Knee OsteoarthritisNCT03898388
Correlating the OA Knee Microenvironment to Outcomes After Regenexx-SD Treatment: A Multi-Site Study
A study testing Bone Marrow Concentrate treatment in people with Knee Osteoarthritis, run by Regenexx, LLC at 3 sites in United States.
Trial summary
Multi-center study to include up to 600 subjects with knee osteoarthritis in unilateral or bilateral knees treated with Regenexx® SD in the osteoarthritic knee/s. Synovial fluid drawn from patients' knee/s prior to receiving Regenexx-SD treatment will be correlated with their clinical outcomes after treatment. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Bone Marrow Concentrate treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Mar 2019to 30 Mar 2022
- Phase
- Interventional
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Voluntary signature of the IRB approved Informed Consent 2) Unilateral or bilateral osteoarthritic male or female ages 35-85 3) Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint 4) Physical examination consistent with osteoarthritis in one knee joint 5) Kellgren-Lawrence grade 2 or greater knee osteoarthritis and/or diagnostic MRI imaging of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus tear, synovial thickening, etc.) 6) Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Who cannot join
- 7) Knee injections of any type within 3 months prior to the study. 8) Knee surgery within 6 months prior to the study.
- 9) Patient undergoing lavage with treatment
- 10) Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout) 11) Quinolone or statin-induced myopathy/tendinopathy 12) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh 13) Contraindications for MRI 14) Condition represents a worker's compensation case 15) Currently involved in a health-related litigation procedure 16) Is pregnant 17) Bleeding disorders 18) Currently taking anticoagulant or immunosuppressive medication 19) Allergy or intolerance to study medication 20) Use of chronic opioid 21) Documented history of drug abuse within six months of treatment 22) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Interventional Orthopedics of Atlanta
Atlanta, Georgia, 30305
Regenexx Des Moines
Des Moines, Iowa, 50321
Regenexx Las Vegas
Las Vegas, Nevada, 89074
About this study
Official title: A Prospective Analysis Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx® SD Treatment: A Multi-Site Study
Multi-center study to include up to 600 subjects with knee osteoarthritis in unilateral or bilateral knees treated with Regenexx® SD in the osteoarthritic knee/s. Synovial fluid drawn from patients' knee/s prior to receiving Regenexx-SD treatment will be correlated with their clinical outcomes after treatment.
Read the detailed description
Initial study procedures include baseline evaluation of medical history, knee history, knee examination, medication use, MRI, and subject-reported outcomes.
Each osteoarthritic subject will undergo withdrawal of knee joint synovial fluid for each knee being treated (0.3-0.5 ml) which will be analyzed by the research laboratory via multiplexed enzyme linked immunosorbent assay (ELISA) and dimethylmethylene blue assay (DMMB) at pre-injection (2-8 days before Regenexx-SD treatment). Documentation of osteoarthritic joint characteristics and injection procedure details will be recorded throughout the study.
The unaffected knee joint will undergo no treatment, but bilateral knees may be treated.
The objective of this study is to correlate the pre- Regenexx-SD treatment levels of pro-inflammatory cytokines, anti-inflammatory cytokines, matrix metalloproteinases, and catabolic articular cartilage breakdown products in the osteoarthritic knee synovial fluid microenvironment with 6 month post-treatment clinical outcomes. This data will be used to establish a predictive a priori testing "model" to determine if a patient is a good candidate for the Regenexx-SD treatment based on their initial osteoarthritic knee synovial fluid microenvironment phenotype. It may also be used to determine if the micro-environment can be altered to improve outcome before receiving Regenexx-SD.
Incidence of post-operative complications, adverse events, re-injections, and surgical intervention and change in pain score will be considered while determining these direct and indirect associations upon completion of the Regenexx-SD treatment.
Components of the synovial fluid will be correlated to post-treatment clinical outcomes, which include several self-reported questionnaires as well as assessment of post-injection complications, adverse events, re-injections and surgical interventions. Patient reported questionnaires include IKDC Subjective Knee Evaluation, Lower Extremity Function Scale, Pain Scales and a Modified Single Assessment Numeric Evaluation (SANE).
- Conditions
- Knee Osteoarthritis
- Being tested
- Bone Marrow Concentrate treatment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Concentrate treatmentProcedure or surgery
Also called Regenexx®SD Treatment
Correlate patient outcomes 6 months after receiving the Regenexx SD treatment with measurements of synovial fluid collected before treatment
| Study group | Role | What they receive |
|---|---|---|
| Knee Synovial Fluid collection before Regenexx-SD | Experimental | Measure components of knee synovial fluid 2-4 days before the Regenexx-SD treatment. Receives: Procedure: Bone Marrow Concentrate treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between components in knee synovial fluid to patient-reported outcomes post-procedure.
- Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to IKDC delta scores at 6 months.
Measured: 6 months after Regenexx-SD treatment
Secondary outcomes (7)
Correlation between components of synovial fluid to 12 month IKDC outcomes
Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to IKDC delta scores at 12 months.
Measured: 12 months
Correlation between components of synovial fluid and 6 month pain score
Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to pain scale deltas at 6 months.
Measured: 6 months
Correlation between components of synovial fluid and 6 month Lower Extremity Function Scale (LEFS).
Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to LEFS deltas at 6 months.
Measured: 6 months
Correlation between components of synovial fluid and 6 month modified Single Assessment Numeric Evaluation (SANE)
Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to SANE scores at 6 months.
Measured: 6 months
Correlation between components of synovial fluid and 12 month pain scores
Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to pain scale deltas at 12 months.
Measured: 12 months
Correlation between components of synovial fluid and 12 month LEFS
Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to LEFS deltas at 12 months.
Measured: 12 months
Correlation between components of synovial fluid and modified SANE
Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to modified SANE scores at 12 months.
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 posted2 Apr 2019
- Study start21 Mar 2019
- Primary completion30 Oct 2020
- Study completion30 Mar 2022
Why it stopped: sponsor discontinued study-impacted by COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Centeno, MD, Principal investigator, Regenexx, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898388
- Sponsor's protocol ID
- RGX2018-LAB01
- Status last verified
- Sep 2023
- First submitted
- 29 Mar 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Centeno CJ, Al-Sayegh H, Bashir J, Goodyear S, Freeman MD. A dose response analysis of a specific bone marrow concentrate treatment protocol for knee osteoarthritis. BMC Musculoskelet Disord. 2015 Sep 18;16:258. doi: 10.1186/s12891-015-0714-z.
PubMed 26385099Centeno C, Sheinkop M, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2 year follow-up. J Transl Med. 2018 Dec 13;16(1):355. doi: 10.1186/s12967-018-1736-8.
PubMed 30545387Themistocleous GS, Chloros GD, Kyrantzoulis IM, Georgokostas IA, Themistocleous MS, Papagelopoulos PJ, Savvidou OD. Effectiveness of a single intra-articular bone marrow aspirate concentrate (BMAC) injection in patients with grade 3 and 4 knee osteoarthritis. Heliyon. 2018 Oct 18;4(10):e00871. doi: 10.1016/j.heliyon.2018.e00871. eCollection 2018 Oct.
PubMed 30364761Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30.
PubMed 27026621
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx® SD Treatment: A Multi-Site Study
- ClinicalTrials.gov ID
- NCT03898388
- Acronym / sponsor ID
- RGX2018-LAB01
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor discontinued study-impacted by COVID
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 2 Apr 2019 (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.
Multi-center study to include up to 600 subjects with knee osteoarthritis in unilateral or bilateral knees treated with Regenexx® SD in the osteoarthritic knee/s. Synovial fluid drawn from patients' knee/s prior to receiving Regenexx-SD treatment will be correlated with their clinical outcomes after treatment.
Detailed description
Initial study procedures include baseline evaluation of medical history, knee history, knee examination, medication use, MRI, and subject-reported outcomes.
Each osteoarthritic subject will undergo withdrawal of knee joint synovial fluid for each knee being treated (0.3-0.5 ml) which will be analyzed by the research laboratory via multiplexed enzyme linked immunosorbent assay (ELISA) and dimethylmethylene blue assay (DMMB) at pre-injection (2-8 days before Regenexx-SD treatment). Documentation of osteoarthritic joint characteristics and injection procedure details will be recorded throughout the study.
The unaffected knee joint will undergo no treatment, but bilateral knees may be treated.
The objective of this study is to correlate the pre- Regenexx-SD treatment levels of pro-inflammatory cytokines, anti-inflammatory cytokines, matrix metalloproteinases, and catabolic articular cartilage breakdown products in the osteoarthritic knee synovial fluid microenvironment with 6 month post-treatment clinical outcomes. This data will be used to establish a predictive a priori testing "model" to determine if a patient is a good candidate for the Regenexx-SD treatment based on their initial osteoarthritic knee synovial fluid microenvironment phenotype. It may also be used to determine if the micro-environment can be altered to improve outcome before receiving Regenexx-SD.
Incidence of post-operative complications, adverse events, re-injections, and surgical intervention and change in pain score will be considered while determining these direct and indirect associations upon completion of the Regenexx-SD treatment.
Components of the synovial fluid will be correlated to post-treatment clinical outcomes, which include several self-reported questionnaires as well as assessment of post-injection complications, adverse events, re-injections and surgical interventions. Patient reported questionnaires include IKDC Subjective Knee Evaluation, Lower Extremity Function Scale, Pain Scales and a Modified Single Assessment Numeric Evaluation (SANE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Synovial Fluid collection before Regenexx-SD | Experimental | Procedure: Bone Marrow Concentrate treatmentMeasure components of knee synovial fluid 2-4 days before the Regenexx-SD treatment. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Voluntary signature of the IRB approved Informed Consent 2) Unilateral or bilateral osteoarthritic male or female ages 35-85 3) Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint 4) Physical examination consistent with osteoarthritis in one knee joint 5) Kellgren-Lawrence grade 2 or greater knee osteoarthritis and/or diagnostic MRI imaging of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus tear, synovial thickening, etc.) 6) Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Key exclusion criteria (3 listed)
- 7) Knee injections of any type within 3 months prior to the study. 8) Knee surgery within 6 months prior to the study.
- 9) Patient undergoing lavage with treatment
- 10) Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout) 11) Quinolone or statin-induced myopathy/tendinopathy 12) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh 13) Contraindications for MRI 14) Condition represents a worker's compensation case 15) Currently involved in a health-related litigation procedure 16) Is pregnant 17) Bleeding disorders 18) Currently taking anticoagulant or immunosuppressive medication 19) Allergy or intolerance to study medication 20) Use of chronic opioid 21) Documented history of drug abuse within six months of treatment 22) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
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 |
|---|---|---|
| Bone Marrow Concentrate treatmentAlso: Regenexx®SD TreatmentCorrelate patient outcomes 6 months after receiving the Regenexx SD treatment with measurements of synovial fluid collected before treatment | Procedure or surgery | Knee Synovial Fluid collection before Regenexx-SD |
Primary outcome
Correlation between components in knee synovial fluid to patient-reported outcomes post-procedure.
Time frame: 6 months after Regenexx-SD treatment
1) Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to IKDC delta scores at 6 months.
7 secondary outcomes
Correlation between components of synovial fluid to 12 month IKDC outcomes
Time frame: 12 months
Correlation between components of synovial fluid and 6 month pain score
Time frame: 6 months
Correlation between components of synovial fluid and 6 month Lower Extremity Function Scale (LEFS).
Time frame: 6 months
Correlation between components of synovial fluid and 6 month modified Single Assessment Numeric Evaluation (SANE)
Time frame: 6 months
Correlation between components of synovial fluid and 12 month pain scores
Time frame: 12 months
Correlation between components of synovial fluid and 12 month LEFS
Time frame: 12 months
Correlation between components of synovial fluid and modified SANE
Time frame: 12 months
Results and safety
The study was stopped early (reason given: sponsor discontinued study-impacted by COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 26385099Centeno CJ, Al-Sayegh H, Bashir J, Goodyear S, Freeman MD. A dose response analysis of a specific bone marrow concentrate treatment protocol for knee osteoarthritis. BMC Musculoskelet Disord. 2015 Sep 18;16:258. doi: 10.1186/s12891-015-0714-z.
- Background: PubMed 30545387Centeno C, Sheinkop M, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2 year follow-up. J Transl Med. 2018 Dec 13;16(1):355. doi: 10.1186/s12967-018-1736-8.
- Background: PubMed 30364761Themistocleous GS, Chloros GD, Kyrantzoulis IM, Georgokostas IA, Themistocleous MS, Papagelopoulos PJ, Savvidou OD. Effectiveness of a single intra-articular bone marrow aspirate concentrate (BMAC) injection in patients with grade 3 and 4 knee osteoarthritis. Heliyon. 2018 Oct 18;4(10):e00871. doi: 10.1016/j.heliyon.2018.e00871. eCollection 2018 Oct.
- Background: PubMed 27026621Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30.
- Individual participant dataSharing planned: No
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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.
Christopher Centeno, MD principal investigator
Regenexx, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow Concentrate treatment in people with Knee Osteoarthritis, run by Regenexx, LLC at 3 sites in United States.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: sponsor discontinued study-impacted by COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between components in knee synovial fluid to patient-reported outcomes post-procedure. (time frame: 6 months after Regenexx-SD treatment). 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 NCT03898388, which also lists 4 linked publications.
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 Sep 2023.