Mesenchymal Stem CellsPhase 1/2NCT04863183
Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis
A Phase 1/2 study testing CELLISTEM-OA and Triamcinolone acetonide in people with Mesenchymal Stem Cells and Knee Osteoarthritis, run by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle.
Trial summary
Symptomatic knee osteoarthritis is a serious public health problem in the world, it carries a high personal, social and economic impact. Currently, there are no drugs that modify the natural course of the disease. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Mesenchymal Stem Cells, Knee Osteoarthritis, Cell Therapy
- What is being tested?
- CELLISTEM-OA and Triamcinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 30 Jun 2022
- Phase
- Phase 1/2
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who / with:
- Osteoarthritis of the knee.
- Kellgren II or III to knee radiography.
- 30 to 75 years inclusive.
- Pain scale greater than 40 over 100 mm.
- MRI with G I, II or III chondral knee injury with or without stable degenerative meniscal injury.
Show all 10Show fewer
- Stable knee.
- Examination of the rest of the normal limb.
- Willingness to participate in the study for 1 year.
- Ability to understand and willingness to sign the informed consent.
Who cannot join
- Patients who / with:
- Symptomatic contralateral knee osteoarthritis.
- Significant knee trauma in the preceding 3 months.
- Wound or skin lesion in the knee studied.
- Anatomical valgus greater than 10º.
- Anatomical varus greater than 5º.
Show all 27Show fewer
- Clinically significant joint effusion.
- Edema greater than 20% of the surface of the plateau or condyle in NMR.
- Previously known alterations in the hip and / or spine.
- Predominant patellofemoral pathology (radiographs with IWANO II osteoarthritis or more).
- Any type of inflammatory arthritis.
- History of active infections including HIV, HBV and HCV.
- Results of laboratory tests (hemogram and CRP) outside the normal ranges.
- Presence of fever on day -1 or day 0.
- Use of oral corticosteroids.
- Use of anticoagulants.
- Immunosuppression, uncontrolled diabetes mellitus, hyperthyroidism, psychiatric illnesses
- Active neoplasia or during the preceding 5 years.
- Pregnancy or breastfeeding (b-Hcg positive).
- Use of drugs or alcoholism.
- IA injections or knee surgeries in the last 180 days.
- BMI> 35.
- Any type of metallic implant susceptible to displacement with MRI.
- Use of pacemakers.
- History of severe allergy or anaphylactic shock.
- Significant alterations in the evaluation of the initial laboratory tests.
- Any factor that, in the opinion of the investigator, may affect the adequate follow-up of the patient during the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cell Therapy for Patients With Symptomatic Knee Osteoarthritis: Phase I / II, Controlled, Randomized and Double-blind Clinical Trial
Symptomatic knee osteoarthritis is a serious public health problem in the world, it carries a high personal, social and economic impact. Currently, there are no drugs that modify the natural course of the disease. As analgesic therapy becomes insufficient, more invasive measures are applied, ultimately leading to arthroplasty.
The scientific community has joined efforts to develop new therapeutic approaches that allow the delay and regeneration of injured tissue in these patients. These include cell therapy with mesenchymal stem cells derived from different sources. Although most of the clinical studies carried out in different parts of the world with this therapy in patients with knee osteoarthritis have shown therapeutic benefit, it is necessary to develop clinical trials with high quality in our population.
Read more
The aim of this project is to evaluate the safety, tolerance and efficacy of Cellistem-OA (biological therapy based on mesenchymal stem cells derived from Wharton's jelly of umbilical cord) in patients with knee osteoarthritis in the Colombian population.
Investigators proposed to carry out an experimental (clinical trial), randomized, controlled and parallel with 30 participants with knee knee osteoarthritis of the medical complex Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle. The participants will be randomized into two groups: i) 15 patients who will receive a dose of 2 x 106 Cellistem-OA and ii) 15 patients who will receive an active comparator (acetonide of triamcinolone 10mg / mL), which will be administered by intra-articular injection in the superolateral aspect of the knee. The outcomes to be evaluated will be: (i) decrease in joint pain, (ii) increase in joint functionality, (iii) improvement in quality of life and (iv) improvement of articular cartilage. These parameters will be evaluated at weeks 1, 4, 8, 12, 24, 25, 28, 32, 36 and 52 post-treatments. Additionally, local and systemic adverse events will be recorded to establish whether or not there is an association between them and the intervention.
Read the detailed description
Type of study Controlled, randomized, double-blind clinical trial comparing CELLISTEM-OA and active comparator (triamcinolone acetonide).
Study population Patients from the Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle who consult the trauma and rheumatology service by knee osteoarthritis. Patients who show interest in participating will be cited to an interview with the researchers where both the objectives and the research procedures will be explained.
Sample size The sample size considered are 30 participants distributed in two groups.
Group 1 (control) active comparator: triamcinolone acetonide (10mg / mL) via intra-articular, 5 cc.
Group 2 (experimental): CELLISTEM-OA via intra-articular, doses of 2 x 106 cells in 5cc of saline solution.
The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments using sterile technique, after cooling the skin with local ice.
- Conditions
- Mesenchymal Stem Cells, Knee Osteoarthritis, Cell Therapy
- Being tested
- CELLISTEM-OA, Triamcinolone acetonide
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELLISTEM-OABiological
Also called Mesenchymal stem cells
The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice.
Triamcinolone acetonideDrug
Also called Kenacort-A
The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (control-Triamcinolone acetonide) | Active comparator | Triamcinolone acetonide (10mg / mL) via intra-articular, 5 cc, one dose (zero time). Receives: Drug: Triamcinolone acetonide |
| Group 2 (experimental- CELLISTEM-OA) | Experimental | CELLISTEM-OA via intra-articular, doses of 2 x 106 mesenchymal stem cells in 5cc of saline solution, one dose (zero time). Receives: Biological: CELLISTEM-OA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in joint pain
Pain will be measured through visual analog scale (VAS).
Measured: 12 months
Increased joint functionality
Joint functionality will be measured through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Measured: 12 months
Improvement in the quality of life
Quality of life will be measured through the Short Form 36 Health Survey Questionnaire (SF-36).
Measured: 12 months
Imaging improvement of articular cartilage
The improvement of articular cartilage will be evaluated by nuclear magnetic resonance (NMR).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal Stem CellsStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, randomized, double-blind clinical trial comparing CELLISTEM-OA and active comparator (triamcinolone acetonide).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
- Sponsor type
- University, hospital or other
- Collaborators
- Cells for Cells
- Responsible party
- Principal investigator, Martha Ligia Arango Rodríguez, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
- Investigators
- Martha L Arango, PhD, Principal investigator, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863183
- Sponsor's protocol ID
- OA-01
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Therapy for Patients With Symptomatic Knee Osteoarthritis: Phase I / II, Controlled, Randomized and Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04863183
- Acronym / sponsor ID
- OA-01
- Conditions
- Mesenchymal Stem Cells, Knee Osteoarthritis, Cell Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación Oftalmológica de Santander Clínica Carlos Ardila LulleUniversity, hospital or other
- Collaborators
- Cells for Cells
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 28 Apr 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.
Symptomatic knee osteoarthritis is a serious public health problem in the world, it carries a high personal, social and economic impact. Currently, there are no drugs that modify the natural course of the disease. As analgesic therapy becomes insufficient, more invasive measures are applied, ultimately leading to arthroplasty.
The scientific community has joined efforts to develop new therapeutic approaches that allow the delay and regeneration of injured tissue in these patients. These include cell therapy with mesenchymal stem cells derived from different sources. Although most of the clinical studies carried out in different parts of the world with this therapy in patients with knee osteoarthritis have shown therapeutic benefit, it is necessary to develop clinical trials with high quality in our population.
The aim of this project is to evaluate the safety, tolerance and efficacy of Cellistem-OA (biological therapy based on mesenchymal stem cells derived from Wharton's jelly of umbilical cord) in patients with knee osteoarthritis in the Colombian population.
Investigators proposed to carry out an experimental (clinical trial), randomized, controlled and parallel with 30 participants with knee knee osteoarthritis of the medical complex Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle. The participants will be randomized into two groups: i) 15 patients who will receive a dose of 2 x 106 Cellistem-OA and ii) 15 patients who will receive an active comparator (acetonide of triamcinolone 10mg / mL), which will be administered by intra-articular injection in the superolateral aspect of the knee. The outcomes to be evaluated will be: (i) decrease in joint pain, (ii) increase in joint functionality, (iii) improvement in quality of life and (iv) improvement of articular cartilage. These parameters will be evaluated at weeks 1, 4, 8, 12, 24, 25, 28, 32, 36 and 52 post-treatments. Additionally, local and systemic adverse events will be recorded to establish whether or not there is an association between them and the intervention.
Detailed description
Type of study Controlled, randomized, double-blind clinical trial comparing CELLISTEM-OA and active comparator (triamcinolone acetonide).
Study population Patients from the Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle who consult the trauma and rheumatology service by knee osteoarthritis. Patients who show interest in participating will be cited to an interview with the researchers where both the objectives and the research procedures will be explained.
Sample size The sample size considered are 30 participants distributed in two groups.
Group 1 (control) active comparator: triamcinolone acetonide (10mg / mL) via intra-articular, 5 cc.
Group 2 (experimental): CELLISTEM-OA via intra-articular, doses of 2 x 106 cells in 5cc of saline solution.
The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments using sterile technique, after cooling the skin with local ice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Controlled, randomized, double-blind clinical trial comparing CELLISTEM-OA and active comparator (triamcinolone acetonide).
| Arm | Type | Receives |
|---|---|---|
| Group 1 (control-Triamcinolone acetonide) | Active comparator | Drug: Triamcinolone acetonideTriamcinolone acetonide (10mg / mL) via intra-articular, 5 cc, one dose (zero time). |
| Group 2 (experimental- CELLISTEM-OA) | Experimental | Biological: CELLISTEM-OACELLISTEM-OA via intra-articular, doses of 2 x 106 mesenchymal stem cells in 5cc of saline solution, one dose (zero time). |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Osteoarthritis of the knee.
- Kellgren II or III to knee radiography.
- 30 to 75 years inclusive.
- Pain scale greater than 40 over 100 mm.
- MRI with G I, II or III chondral knee injury with or without stable degenerative meniscal injury.
Key exclusion criteria (27 listed)
- Symptomatic contralateral knee osteoarthritis.
- Significant knee trauma in the preceding 3 months.
- Wound or skin lesion in the knee studied.
- Anatomical valgus greater than 10º.
- Anatomical varus greater than 5º.
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 |
|---|---|---|
| CELLISTEM-OAAlso: Mesenchymal stem cellsThe intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice. | Biological | Group 2 (experimental- CELLISTEM-OA) |
| Triamcinolone acetonideAlso: Kenacort-AThe intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice. | Drug | Group 1 (control-Triamcinolone acetonide) |
Primary outcome
Decrease in joint pain
Time frame: 12 months
Pain will be measured through visual analog scale (VAS).
Increased joint functionality
Time frame: 12 months
Joint functionality will be measured through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Improvement in the quality of life
Time frame: 12 months
Quality of life will be measured through the Short Form 36 Health Survey Questionnaire (SF-36).
Imaging improvement of articular cartilage
Time frame: 12 months
The improvement of articular cartilage will be evaluated by nuclear magnetic resonance (NMR).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Mesenchymal Stem Cells
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Not yet recruitingPhase 1/2
cfMSC Therapy for Diabetes
Type II Diabetes Mellitus
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.
Martha L Arango, PhD principal investigator
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CELLISTEM-OA and Triamcinolone acetonide in people with Mesenchymal Stem Cells and Knee Osteoarthritis, run by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle.
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 10 inclusion and 27 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 28 Apr 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Martha L Arango, PhD ((57) 3226816547, martha.arango@foscal.com.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in joint pain (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2021.