Osteoarthritis, KneeEarly Phase 1NCT04971798
Cell-free Stem Cell-derived Extract Formulation for Knee Osteoarthritis
A Early Phase 1 study testing Cell-free Stem Cell-derived Extract Formulation (CCM) in people with Osteoarthritis, Knee, run by General Therapeutics.
Trial summary
The purpose of this study is to determine the safety and efficacy of intraarticular injection of Cell-free Stem Cell-derived Extract Formulation for treatment of knee osteoarthritis symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Cell-free Stem Cell-derived Extract Formulation (CCM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older at the time of enrollment
- Have a body mass index (BMI) of ≤ 35Kg/m2
- Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after thorough explanation of the subject's participation has been provided
- Be willing and capable of subjective evaluation, reading and understanding written questionnaires, and reading, understanding and signing the written informed consent
- Has been diagnosed with Mild to Moderate knee osteoarthritis (OA) in one knee only, with a Grade 2 or 3 on the Kellgren Lawrence (KL) grading scale
- Has an average knee pain intensity ≥ 6 of the Numerical Pain Rating Scale (NPRS); Scale 0 to 10
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- Be willing to not take any knee symptom modifying drugs from baseline through the End of Study
- Be willing and able to comply with study-related requirements, procedures, and visits
- If female, sexually active, and of childbearing age, subject must be willing to use a reliable form of birth control throughout the duration of the study. If Male, sexually active with partners of childbearing age, must be willing to use contraceptive measures
Who cannot join
- Has taken any pain medications, including NSAIDs, within 15 days prior to the study injection date
- Current use of anticoagulants or history of regular use of anticoagulants
- History of addiction to dependency producing medications or history of a substance abuse (including alcohol and illicit drugs)
- Has mechanical knee symptoms consistent with extensive intraarticular pathology not amenable to injection therapy alone, including clinical or imaging evidence indicative of ACL, MCL, LCL, or meniscal pathology
- Has undergone intraarticular injection of any drug including but not limited to corticosteroids or viscosupplementation in the index knee in the last 3 months
- History of any type of surgery on the index knee
Show all 20Show fewer
- History of traumatic injury to the index knee within the last 3 months
- Has planned elective knee surgery during the course of the study
- History of organ or hematologic transplantation
- History of rheumatoid arthritis or other autoimmune disorders
- History of immunosuppressive medication/treatment or cancer diagnosis within the last 5 years
- Current knee infection or history of using antibiotics for knee infection within the last 3 months
- Has participated in another clinical study or received treatment with any investigational product within 30 days of enrollment
- Is pregnant as determined by urine testing unless female subject is surgically sterile or post-menopausal
- Currently breastfeeding or desires to be pregnant during the course of the study
- Has contraindications to X-ray or MRI imaging
- Has a diagnosis of progressive neurological disease
- Has a diagnosis of an active psychological or psychiatric disorder
- Has pain in other area(s) and/or medical condition(s) that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of the study
- Has unresolved major issues of secondary gain (e.g., social, financial, or legal (e.g., worker's compensation claim)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Non-randomized, Open-label, Multi-center, Prospective Study to Evaluate the Safety and Efficacy of Intraarticular Injection of Cell-free Stem Cell-derived Extract Formulation in Patients Suffering From Knee Osteoarthritis
The purpose of this study is to determine the safety and efficacy of intraarticular injection of Cell-free Stem Cell-derived Extract Formulation for treatment of knee osteoarthritis symptoms.
Read the detailed description
Osteoarthritis and other orthopaedic acute and degenerative conditions affect millions of people each year, resulting in significant pain and disability. Conservative modalities are limited, as they may not reverse the underlying pathology and may only provide minimal relief.
To address the limitations of traditional conservative modalities, there has been substantial interest in biologics for musculoskeletal regenerative medicine applications. The efficacy of these biologics is attributed to the presence of stem cells, growth factors (GFs), cytokines (CKs), and extracellular vesicles (EVs) including exosomes.
However, first generation biologics, specifically whole stem cell products, are not without their own inherent limitations, including establishing a reliable source with a stable phenotype, genetic instability and chromosomal aberrations, intravenous administration related toxicities caused by the physical trapping of the cells in the lung microvasculature, rejection by the host, formation of ectopic tissue, and tumorigenicity.
When considering how to harness the value of current biologics into a next generation product that can address existing limitations, it is important to consider current foundational knowledge regarding the mechanism of action of stem cell products. Recent literature regarding the beneficial effects of mesenchymal stem cells (MSCs) postulates that the mechanism of action is not due to their ability to grow and differentiate. Rather, it is secondary to their secretion of bioactive molecules such as growth factors, cytokines, and exosomes. GFs, secreted from stem cells, induce signal transduction pathways that initiate cell migration, proliferation, growth, and differentiation. CKs, similarly, can regulate inflammation, immune response, cellular differentiation, and tissue remodeling. Exosomes also are secreted by mesenchymal stem cells and act as a paracrine mediator to target cells, providing a regenerative microenvironment for damaged tissues.
As existing literature establishes that these aforementioned components of stem cells lead to regenerative responses, we have accordingly sought to establish if a sub-cellular approach to biologics can provide similar benefits while avoiding the risk profile, including immunogenicity, infection, and the potential for tumorgenicity, associated with whole stem cell products. In support of this hypothesis, recent studies have demonstrated that MSCs-derived exosomes can act as a cell-free therapeutic alternative to whole cell therapy with great regenerative potential. In addition, to the benefits by means of risk elimination, there may be further therapeutic benefits of a cellular derived therapeutic approach. For example, exosomes due to their smaller size, have the potential to migrate to target organs efficiently after, without getting trapped in the lung microvasculature. Additionally, a higher concentration of "active ingredients" can be administered directly to the patient, which may induce a larger healing response than is possible with whole stem cell therapies.
To meet these goals of improving the risk profile and therapeutic benefit of regenerative medicine, we have formulated a novel cell-free stem cell-derived extract, CCM, from human progenitor endothelial stem cells (hPESCs). Our preliminary results demonstrated presence of several GFs, anti-inflammatory CKs and EVs including exosomes in this formulation. Functionally, this formulation also significantly enhanced cell proliferation and induced stem cell migration.
The goal of this proposed study is to evaluate the safety and efficacy of intraarticular injection of this cell-free stem cell-derived extract formulation for treatment of knee osteoarthritis symptoms. We hypothesize that intraarticular administration of this cell-free stem cell-derived extract formulation is safe. We also hypothesize that patients receiving intraarticular injection of this formulation will show an improvement in their overall satisfaction, Numeric Pain rating Scale (NPRS), Patient-Reported Outcomes Measurement Information System (PROMIS) score and Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) over a period of 2-years compared to the baseline visit. Our null hypothesis is that there is no difference between baseline and follow-up visits for any outcome measures.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Cell-free Stem Cell-derived Extract Formulation (CCM)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-free Stem Cell-derived Extract Formulation (CCM)Biological
Intraarticular injection
| Study group | Role | What they receive |
|---|---|---|
| Cell-free Stem cell-derived Extract Formulation (CCM) | Experimental | Intraarticular administration of CCM Receives: Biological: Cell-free Stem Cell-derived Extract Formulation (CCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile
Measured: 1 week
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile
Measured: 6 weeks
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile
Measured: 3 Months
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile
Measured: 6 Months
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile
Measured: 12 Months
Treatment-emergent adverse effects as assessed by Creatinine levels
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels
Measured: 1 Week
Treatment-emergent adverse effects as assessed by Creatinine levels
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels
Measured: 6 Weeks
Treatment-emergent adverse effects as assessed by Creatinine levels
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels
Measured: 3 Months
Treatment-emergent adverse effects as assessed by Creatinine levels
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels
Measured: 6 Months
Treatment-emergent adverse effects as assessed by Creatinine levels
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels
Measured: 12 Months
Treatment-emergent adverse effects as assessed by Liver Function Test
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test
Measured: 1 Week
Treatment-emergent adverse effects as assessed by Liver Function Test
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test
Measured: 6 Weeks
Treatment-emergent adverse effects as assessed by Liver Function Test
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test
Measured: 3 Months
Treatment-emergent adverse effects as assessed by Liver Function Test
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test
Measured: 6 Months
Treatment-emergent adverse effects as assessed by Liver Function Test
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test
Measured: 12 Months
Treatment-emergent adverse effects as assessed by Complete Blood Count
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count
Measured: 1 Week
Treatment-emergent adverse effects as assessed by Complete Blood Count
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count
Measured: 6 Weeks
Treatment-emergent adverse effects as assessed by Complete Blood Count
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count
Measured: 3 Months
Treatment-emergent adverse effects as assessed by Complete Blood Count
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count
Measured: 6 Months
Treatment-emergent adverse effects as assessed by Complete Blood Count
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count
Measured: 12 Months
Treatment-emergent adverse effects as assessed by C-reactive protein
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein
Measured: 1 Week
Treatment-emergent adverse effects as assessed by C-reactive protein
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein
Measured: 6 Weeks
Treatment-emergent adverse effects as assessed by C-reactive protein
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein
Measured: 3 Months
Treatment-emergent adverse effects as assessed by C-reactive protein
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein
Measured: 6 Months
Treatment-emergent adverse effects as assessed by C-reactive protein
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein
Measured: 12 Months
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate
Measured: 1 Week
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate
Measured: 6 Weeks
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate
Measured: 3 Months
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate
Measured: 6 Months
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate
Measured: 12 Months
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets
Measured: 1 Week
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets
Measured: 6 Weeks
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets
Measured: 3 Months
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets
Measured: 6 Months
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets
Measured: 12 Months
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels
Measured: 1 Week
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels
Measured: 6 Weeks
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels
Measured: 3 Months
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels
Measured: 6 Months
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels
Measured: 12 Months
Secondary outcomes (45)
Change in patient reported outcome measures, Numeric Pain Rating Scale
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.
Measured: Change from baseline to immediately after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.
Measured: Change from baseline to 24 hours after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.
Measured: Change from baseline to 48 hours after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.
Measured: Change from baseline to 1 week after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.
Measured: Change from baseline to 6 weeks after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.
Measured: Change from baseline to 3 months after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.
Measured: Change from baseline to 6 months after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.
Measured: Change from baseline to 12 months after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.
Measured: Change from baseline to 18 months after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
To determine change in patient reported outcome measure, Numeric Pain Rating Scale (NPRS). A decrease in score indicates improvement.
Measured: Change from baseline to 24 months after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.
Measured: Change from baseline to 1 week after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.
Measured: Change from baseline to 6 weeks after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.
Measured: Change from baseline to 3 months after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.
Measured: Change from baseline to 6 months after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.
Measured: Change from baseline to 12 months after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.
Measured: Change from baseline to 18 months after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
To determine change in patient reported outcome measure, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.). An increase in score indicates improvement.
Measured: Change from baseline to 24 months after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.
Measured: Change from baseline to 1 week after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.
Measured: Change from baseline to 6 weeks after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.
Measured: Change from baseline to 3 months after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.
Measured: Change from baseline to 6 months after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.
Measured: Change from baseline to 12 months after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.
Measured: Change from baseline to 18 months after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
To determine change in patient reported outcome measure, Patient-Reported Outcomes Measurement Information System (PROMIS) score. An increase in score indicates improvement.
Measured: Change from baseline to 24 months after injection
Patient Satisfaction via 5-point Likert Scale
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.
Measured: 1 Week after injection
Patient Satisfaction via 5-point Likert Scale
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.
Measured: 6 Weeks after injection
Patient Satisfaction via 5-point Likert Scale
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.
Measured: 3 Months after injection
Patient Satisfaction via 5-point Likert Scale
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.
Measured: 6 Months after injection
Patient Satisfaction via 5-point Likert Scale
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.
Measured: 12 Months after injection
Patient Satisfaction via 5-point Likert Scale
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.
Measured: 18 Months after injection
Patient Satisfaction via 5-point Likert Scale
To determine patient satisfaction via 5-point Likert Scale. An increase in score indicates improvement.
Measured: 24 Months after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.
Measured: Change from baseline to 1 week after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.
Measured: Change from baseline to 6 weeks after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.
Measured: Change from baseline to 3 months after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.
Measured: Change from baseline to 6 months after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.
Measured: Change from baseline to 12 months after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.
Measured: Change from baseline to 18 months after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
To determine patient satisfaction via Single Assessment Numeric Evaluation (SANE). An increase in score indicates improvement.
Measured: Change from baseline to 24 months after injection
Patient Satisfaction via 36-item short form survey (SF36)
To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement.
Measured: Change from baseline to 3 months after injection
Patient Satisfaction via 36-item short form survey (SF36)
To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement.
Measured: Change from baseline to 6 months after injection
Patient Satisfaction via 36-item short form survey (SF36)
To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement.
Measured: Change from baseline to 12 months after injection
Patient Satisfaction via 36-item short form survey (SF36)
To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement.
Measured: Change from baseline to 18 months after injection
Patient Satisfaction via 36-item short form survey (SF36)
To determine patient satisfaction via 36-item short form survey (SF36). An increase in score indicates improvement.
Measured: Change from baseline to 24 months after injection
Cartilage Formation
To assess cartilage formation via MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue). An increase in score indicates improvement.
Measured: Change from baseline to 12 months after injection
Cartilage Formation
To assess cartilage formation via MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue). An increase in score indicates improvement.
Measured: Change from baseline to 24 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Cady, PhD, Study director, General Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971798
- Sponsor's protocol ID
- GT - 2021CCM/OA
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gupta A, Maffulli N, Rodriguez HC, Mistovich RJ, Delfino K, Cady C, Fauser AM, Cundiff ED, Martinez MA, Potty AG. Cell-free stem cell-derived extract formulation for treatment of knee osteoarthritis: study protocol for a preliminary non-randomized, open-label, multi-center feasibility and safety study. J Orthop Surg Res. 2021 Aug 20;16(1):514. doi: 10.1186/s13018-021-02672-3.
PubMed 34416898
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Open-label, Multi-center, Prospective Study to Evaluate the Safety and Efficacy of Intraarticular Injection of Cell-free Stem Cell-derived Extract Formulation in Patients Suffering From Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04971798
- Acronym / sponsor ID
- GT - 2021CCM/OA
- Conditions
- Osteoarthritis, Knee
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- General TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of intraarticular injection of Cell-free Stem Cell-derived Extract Formulation for treatment of knee osteoarthritis symptoms.
Detailed description
Osteoarthritis and other orthopaedic acute and degenerative conditions affect millions of people each year, resulting in significant pain and disability. Conservative modalities are limited, as they may not reverse the underlying pathology and may only provide minimal relief.
To address the limitations of traditional conservative modalities, there has been substantial interest in biologics for musculoskeletal regenerative medicine applications. The efficacy of these biologics is attributed to the presence of stem cells, growth factors (GFs), cytokines (CKs), and extracellular vesicles (EVs) including exosomes.
However, first generation biologics, specifically whole stem cell products, are not without their own inherent limitations, including establishing a reliable source with a stable phenotype, genetic instability and chromosomal aberrations, intravenous administration related toxicities caused by the physical trapping of the cells in the lung microvasculature, rejection by the host, formation of ectopic tissue, and tumorigenicity.
When considering how to harness the value of current biologics into a next generation product that can address existing limitations, it is important to consider current foundational knowledge regarding the mechanism of action of stem cell products. Recent literature regarding the beneficial effects of mesenchymal stem cells (MSCs) postulates that the mechanism of action is not due to their ability to grow and differentiate. Rather, it is secondary to their secretion of bioactive molecules such as growth factors, cytokines, and exosomes. GFs, secreted from stem cells, induce signal transduction pathways that initiate cell migration, proliferation, growth, and differentiation. CKs, similarly, can regulate inflammation, immune response, cellular differentiation, and tissue remodeling. Exosomes also are secreted by mesenchymal stem cells and act as a paracrine mediator to target cells, providing a regenerative microenvironment for damaged tissues.
As existing literature establishes that these aforementioned components of stem cells lead to regenerative responses, we have accordingly sought to establish if a sub-cellular approach to biologics can provide similar benefits while avoiding the risk profile, including immunogenicity, infection, and the potential for tumorgenicity, associated with whole stem cell products. In support of this hypothesis, recent studies have demonstrated that MSCs-derived exosomes can act as a cell-free therapeutic alternative to whole cell therapy with great regenerative potential. In addition, to the benefits by means of risk elimination, there may be further therapeutic benefits of a cellular derived therapeutic approach. For example, exosomes due to their smaller size, have the potential to migrate to target organs efficiently after, without getting trapped in the lung microvasculature. Additionally, a higher concentration of "active ingredients" can be administered directly to the patient, which may induce a larger healing response than is possible with whole stem cell therapies.
To meet these goals of improving the risk profile and therapeutic benefit of regenerative medicine, we have formulated a novel cell-free stem cell-derived extract, CCM, from human progenitor endothelial stem cells (hPESCs). Our preliminary results demonstrated presence of several GFs, anti-inflammatory CKs and EVs including exosomes in this formulation. Functionally, this formulation also significantly enhanced cell proliferation and induced stem cell migration.
The goal of this proposed study is to evaluate the safety and efficacy of intraarticular injection of this cell-free stem cell-derived extract formulation for treatment of knee osteoarthritis symptoms. We hypothesize that intraarticular administration of this cell-free stem cell-derived extract formulation is safe. We also hypothesize that patients receiving intraarticular injection of this formulation will show an improvement in their overall satisfaction, Numeric Pain rating Scale (NPRS), Patient-Reported Outcomes Measurement Information System (PROMIS) score and Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) over a period of 2-years compared to the baseline visit. Our null hypothesis is that there is no difference between baseline and follow-up visits for any outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell-free Stem cell-derived Extract Formulation (CCM) | Experimental | Biological: Cell-free Stem Cell-derived Extract Formulation (CCM)Intraarticular administration of CCM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be 18 years of age or older at the time of enrollment
- Have a body mass index (BMI) of ≤ 35Kg/m2
- Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after thorough explanation of the subject's participation has been provided
- Be willing and capable of subjective evaluation, reading and understanding written questionnaires, and reading, understanding and signing the written informed consent
- Has been diagnosed with Mild to Moderate knee osteoarthritis (OA) in one knee only, with a Grade 2 or 3 on the Kellgren Lawrence (KL) grading scale
Key exclusion criteria (20 listed)
- Has taken any pain medications, including NSAIDs, within 15 days prior to the study injection date
- Current use of anticoagulants or history of regular use of anticoagulants
- History of addiction to dependency producing medications or history of a substance abuse (including alcohol and illicit drugs)
- Has mechanical knee symptoms consistent with extensive intraarticular pathology not amenable to injection therapy alone, including clinical or imaging evidence indicative of ACL, MCL, LCL, or meniscal pathology
- Has undergone intraarticular injection of any drug including but not limited to corticosteroids or viscosupplementation in the index knee in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell-free Stem Cell-derived Extract Formulation (CCM)Intraarticular injection | Biological | Cell-free Stem cell-derived Extract Formulation (CCM) |
Primary outcome
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile
Time frame: 1 week
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile
Time frame: 6 weeks
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile
Time frame: 3 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile
Time frame: 6 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile
Time frame: 12 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Comprehensive metabolic profile
Treatment-emergent adverse effects as assessed by Creatinine levels
Time frame: 1 Week
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels
Treatment-emergent adverse effects as assessed by Creatinine levels
Time frame: 6 Weeks
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels
Treatment-emergent adverse effects as assessed by Creatinine levels
Time frame: 3 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels
Treatment-emergent adverse effects as assessed by Creatinine levels
Time frame: 6 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels
Treatment-emergent adverse effects as assessed by Creatinine levels
Time frame: 12 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Creatinine levels
Treatment-emergent adverse effects as assessed by Liver Function Test
Time frame: 1 Week
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test
Treatment-emergent adverse effects as assessed by Liver Function Test
Time frame: 6 Weeks
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test
Treatment-emergent adverse effects as assessed by Liver Function Test
Time frame: 3 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test
Treatment-emergent adverse effects as assessed by Liver Function Test
Time frame: 6 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test
Treatment-emergent adverse effects as assessed by Liver Function Test
Time frame: 12 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Liver Function Test
Treatment-emergent adverse effects as assessed by Complete Blood Count
Time frame: 1 Week
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count
Treatment-emergent adverse effects as assessed by Complete Blood Count
Time frame: 6 Weeks
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count
Treatment-emergent adverse effects as assessed by Complete Blood Count
Time frame: 3 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count
Treatment-emergent adverse effects as assessed by Complete Blood Count
Time frame: 6 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count
Treatment-emergent adverse effects as assessed by Complete Blood Count
Time frame: 12 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Complete Blood Count
Treatment-emergent adverse effects as assessed by C-reactive protein
Time frame: 1 Week
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein
Treatment-emergent adverse effects as assessed by C-reactive protein
Time frame: 6 Weeks
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein
Treatment-emergent adverse effects as assessed by C-reactive protein
Time frame: 3 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein
Treatment-emergent adverse effects as assessed by C-reactive protein
Time frame: 6 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein
Treatment-emergent adverse effects as assessed by C-reactive protein
Time frame: 12 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by C-reactive protein
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate
Time frame: 1 Week
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate
Time frame: 6 Weeks
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate
Time frame: 3 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate
Time frame: 6 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate
Treatment-emergent adverse effects as assessed by Erythrocyte Sedimentation Rate
Time frame: 12 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Erythrocyte Sedimentation Rate
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets
Time frame: 1 Week
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets
Time frame: 6 Weeks
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets
Time frame: 3 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets
Time frame: 6 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets
Treatment-emergent adverse effects as assessed by T, B and NK Cell Lymphocyte subsets
Time frame: 12 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by T, B and NK Cell Lymphocyte subsets
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels
Time frame: 1 Week
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels
Time frame: 6 Weeks
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels
Time frame: 3 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels
Time frame: 6 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels
Treatment-emergent adverse effects as assessed by Serum IgG, IgA, IgM and IgE levels
Time frame: 12 Months
To determine safety i.e. adverse events associated with intraarticular administration of CCM as assessed by Serum IgG, IgA, IgM and IgE levels
45 secondary outcomes
Change in patient reported outcome measures, Numeric Pain Rating Scale
Time frame: Change from baseline to immediately after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
Time frame: Change from baseline to 24 hours after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
Time frame: Change from baseline to 48 hours after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
Time frame: Change from baseline to 1 week after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
Time frame: Change from baseline to 6 weeks after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
Time frame: Change from baseline to 3 months after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
Time frame: Change from baseline to 6 months after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
Time frame: Change from baseline to 12 months after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
Time frame: Change from baseline to 18 months after injection
Change in patient reported outcome measures, Numeric Pain Rating Scale
Time frame: Change from baseline to 24 months after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
Time frame: Change from baseline to 1 week after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
Time frame: Change from baseline to 6 weeks after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
Time frame: Change from baseline to 3 months after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
Time frame: Change from baseline to 6 months after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
Time frame: Change from baseline to 12 months after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
Time frame: Change from baseline to 18 months after injection
Change in patient reported outcome measures, Knee Injury and Osteoarthritis Outcome Score Jr.
Time frame: Change from baseline to 24 months after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
Time frame: Change from baseline to 1 week after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
Time frame: Change from baseline to 6 weeks after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
Time frame: Change from baseline to 3 months after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
Time frame: Change from baseline to 6 months after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
Time frame: Change from baseline to 12 months after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
Time frame: Change from baseline to 18 months after injection
Change in patient reported outcome measures, Patient-Reported Outcomes Measurement Information System (PROMIS) score.
Time frame: Change from baseline to 24 months after injection
Patient Satisfaction via 5-point Likert Scale
Time frame: 1 Week after injection
Patient Satisfaction via 5-point Likert Scale
Time frame: 6 Weeks after injection
Patient Satisfaction via 5-point Likert Scale
Time frame: 3 Months after injection
Patient Satisfaction via 5-point Likert Scale
Time frame: 6 Months after injection
Patient Satisfaction via 5-point Likert Scale
Time frame: 12 Months after injection
Patient Satisfaction via 5-point Likert Scale
Time frame: 18 Months after injection
Patient Satisfaction via 5-point Likert Scale
Time frame: 24 Months after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
Time frame: Change from baseline to 1 week after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
Time frame: Change from baseline to 6 weeks after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
Time frame: Change from baseline to 3 months after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
Time frame: Change from baseline to 6 months after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
Time frame: Change from baseline to 12 months after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
Time frame: Change from baseline to 18 months after injection
Patient Satisfaction via Single Assessment Numeric Evaluation (SANE)
Time frame: Change from baseline to 24 months after injection
Patient Satisfaction via 36-item short form survey (SF36)
Time frame: Change from baseline to 3 months after injection
Patient Satisfaction via 36-item short form survey (SF36)
Time frame: Change from baseline to 6 months after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 34416898Gupta A, Maffulli N, Rodriguez HC, Mistovich RJ, Delfino K, Cady C, Fauser AM, Cundiff ED, Martinez MA, Potty AG. Cell-free stem cell-derived extract formulation for treatment of knee osteoarthritis: study protocol for a preliminary non-randomized, open-label, multi-center feasibility and safety study. J Orthop Surg Res. 2021 Aug 20;16(1):514. doi: 10.1186/s13018-021-02672-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Cady, PhD study director
General Therapeutics
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cell-free Stem Cell-derived Extract Formulation (CCM) in people with Osteoarthritis, Knee, run by General Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig Cady, PhD (2174161497, cjcady@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile (time frame: 1 week). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04971798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.