OsteoarthritisPhase 2ADIPOA-2NCT02838069
A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis
A Phase 2 study testing Injection (2x106 ASC/5ml). and Injection (10x106 ASC/5ml). in people with Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects. The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo)… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Injection (2x106 ASC/5ml). and Injection (10x106 ASC/5ml).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2016to Mar 2024
- Phase
- Phase 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined by the American college of Rheumatology (ACR)
- Must meet pain criteria at the time of screening/baseline visit since at least half of the days in the previous month
- NSAID washout of at least 2 days before screening/baseline
Who cannot join
- Previous treatments acting on cartilage or bone metabolism
- Received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months,
- Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening.
- Kellgren-Lawrence Grade 1 or 4 in the index knee on any incidences.
- Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
- History of joint replacement of the knee or hip within the previous 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIb, Prospective, Multicentre, Double-blind, Triple-arm, Randomized Versus Placebo Trial, to Assess the Efficacy of a Single Injection of Either 2 or 10 x 106 Autologous Adipose Derived Mesenchymal Stromal Cells (ASC) in the Treatment of Mild to Moderate Osteoarthritis (OA) of the Knee, Active and Unresponsive to Conservative Therapy for at Least 12 Months
ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects.
The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years.
This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.
- Conditions
- Osteoarthritis
- Being tested
- Injection (2x106 ASC/5ml)., Injection (10x106 ASC/5ml)., Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection (2x106 ASC/5ml).Biological
Injection of Autologous adipose derived stem cells (2x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24.
Injection (10x106 ASC/5ml).Biological
Injection of Autologous adipose derived stem cells (10x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24.
PlaceboOther
Injection of placebo 0.5% glucose in saline with 4.5% alb/5ml The patient of this group will receive one single administration and will be followed for 12 months. A final follow up visit will occur at Month 24.
| Study group | Role | What they receive |
|---|---|---|
| 2x106 ASC intra-articular injection | Experimental | Injection of Autologous adipose derived stem cells (2x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24. Receives: Biological: Injection (2x106 ASC/5ml). |
| 10x106 ASC intra-articular injection | Experimental | Injection of Autologous adipose derived stem cells (10x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24. Receives: Biological: Injection (10x106 ASC/5ml). |
| Placebo | Placebo comparator | 0.5% glucose in saline with 4.5% albumin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of pain or physical function
evaluate the efficacy of ASC in mild to moderate knee OA (KL 2-3) based on increase in the number of "strict" responders defined by improvements from baseline in WOMAC pain or physical function subscores 50% with absolute changes 20 mm at 6 month, compared to placebo
Measured: Month 6
Secondary outcomes (7)
Disability (WOMAC)
assessed by WOMAC questionnaire
Measured: Months 1, 3, 6, 12 and 24
Disability (KOOS)
assessed by KOOS (Knee injury and Osteoarthritis Outcome Score questionnaire)
Measured: Months 1, 3, 6, 12 and 24
Disability (SAS)
assessed by SAS questionnaire (The Short Arthritis Assessment Scale)
Measured: Months 1, 3, 6, 12 and 24
Change in Quality of life
assessed by SF-36 questionnaire
Measured: Months 1, 3, 6, 12 and 24
painkillers consumption
Changes from baseline (Day 0) to months 1, 3, 6, 12 and 24 in use of painkillers
Measured: Months 1, 3, 6, 12 and 24
Structural changes (X-Ray)
Changes from baseline (Day 0) to months 12 and 24 in femorotibial joint space of the index knee on X-ray
Measured: Months 12 and 24
Structural changes (MRI)
Changes from baseline (Day 0) to months 12 and 24 by MOAKS (MRI Osteoarthritis Knee score)
Measured: Months 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start20 Sep 2016
- Primary completionSep 2022
- Study completionMar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Toulouse, Assistance Publique - Hôpitaux de Paris, National University of Ireland, Galway, Ireland, Istituto Ortopedico Rizzoli, Etablissement Français du Sang, Institut National de la Santé Et de la Recherche Médicale, France, European Clinical Research Infrastructure Network, HUMAN MED AG (HM), Stichting Katholieke Universiteit, SPORTS SURGERY CLINIC LIMITED, University of Padova, EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH (EWK), PINTAIL LTD (PT), Centre National de la Recherche Scientifique, France, University of Ulm, Cambridge University Hospitals NHS Foundation Trust, Aries srl (ARIES)
- Responsible party
- Sponsor
- Investigators
- Christian Jorgensen, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838069
- Sponsor's protocol ID
- RECHMPL15_0453
- Acronym
- ADIPOA-2
- Status last verified
- Sep 2025
- First submitted
- 13 Jun 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cosenza S, Toupet K, Maumus M, Luz-Crawford P, Blanc-Brude O, Jorgensen C, Noel D. Mesenchymal stem cells-derived exosomes are more immunosuppressive than microparticles in inflammatory arthritis. Theranostics. 2018 Feb 3;8(5):1399-1410. doi: 10.7150/thno.21072. eCollection 2018.
PubMed 29507629Pers YM, Schrezenmeier H, Fleury-Cappellesso S, Noth U, Rackwitz L, Ferreira R, Berenbaum F, Ruyssen-Witrand A, Thurlings RM, Addimanda O, Lisignoli G, Ramonda R, Shannon F, Punzi L, Baillet A, McCaskie AW, McDonnell S, O'Callaghan J, Turmezei T, Kessler DA, Lotfi R, Rojewski M, Duffy A, Finnerty A, Moisan A, Brochot-Dechet H, Aubery-Rousselet M, Michon A, Bouzas-Rodriguez J, Pullig O, Broussous S, Nogue E, Amico M, Picot MC, Barry F, Jorgensen C; ADIPOA2 consortium. Effect of intra-articular adipose-derived mesenchymal stromal cell versus placebo injection on pain and function in patients with knee osteoarthritis: the ADIPOA2 phase 2b randomised clinical trial. Ann Rheum Dis. 2025 Dec;84(12):2103-2114. doi: 10.1016/j.ard.2025.07.026. Epub 2025 Aug 29.
PubMed 40885690
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Prospective, Multicentre, Double-blind, Triple-arm, Randomized Versus Placebo Trial, to Assess the Efficacy of a Single Injection of Either 2 or 10 x 106 Autologous Adipose Derived Mesenchymal Stromal Cells (ASC) in the Treatment of Mild to Moderate Osteoarthritis (OA) of the Knee, Active and Unresponsive to Conservative Therapy for at Least 12 Months
- ClinicalTrials.gov ID
- NCT02838069
- Acronym / sponsor ID
- ADIPOA-2 / RECHMPL15_0453
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Toulouse, Assistance Publique - Hôpitaux de Paris, National University of Ireland, Galway, Ireland, Istituto Ortopedico Rizzoli, Etablissement Français du Sang, Institut National de la Santé Et de la Recherche Médicale, France, European Clinical Research Infrastructure Network, HUMAN MED AG (HM), Stichting Katholieke Universiteit, SPORTS SURGERY CLINIC LIMITED, University of Padova, EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH (EWK), PINTAIL LTD (PT), Centre National de la Recherche Scientifique, France, University of Ulm, Cambridge University Hospitals NHS Foundation Trust, Aries srl (ARIES)
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Mar 2024 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects.
The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years.
This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2x106 ASC intra-articular injection | Experimental | Biological: Injection (2x106 ASC/5ml).Injection of Autologous adipose derived stem cells (2x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24. |
| 10x106 ASC intra-articular injection | Experimental | Biological: Injection (10x106 ASC/5ml).Injection of Autologous adipose derived stem cells (10x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24. |
| Placebo | Placebo comparator | Other: Placebo0.5% glucose in saline with 4.5% albumin |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined by the American college of Rheumatology (ACR)
- Must meet pain criteria at the time of screening/baseline visit since at least half of the days in the previous month
- NSAID washout of at least 2 days before screening/baseline
Key exclusion criteria (6 listed)
- Previous treatments acting on cartilage or bone metabolism
- Received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months,
- Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening.
- Kellgren-Lawrence Grade 1 or 4 in the index knee on any incidences.
- Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
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 |
|---|---|---|
| Injection (2x106 ASC/5ml).Injection of Autologous adipose derived stem cells (2x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24. | Biological | 2x106 ASC intra-articular injection |
| Injection (10x106 ASC/5ml).Injection of Autologous adipose derived stem cells (10x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24. | Biological | 10x106 ASC intra-articular injection |
| PlaceboInjection of placebo 0.5% glucose in saline with 4.5% alb/5ml The patient of this group will receive one single administration and will be followed for 12 months. A final follow up visit will occur at Month 24. | Other | Placebo |
Primary outcome
Improvement of pain or physical function
Time frame: Month 6
evaluate the efficacy of ASC in mild to moderate knee OA (KL 2-3) based on increase in the number of "strict" responders defined by improvements from baseline in WOMAC pain or physical function subscores 50% with absolute changes 20 mm at 6 month, compared to placebo
7 secondary outcomes
Disability (WOMAC)
Time frame: Months 1, 3, 6, 12 and 24
Disability (KOOS)
Time frame: Months 1, 3, 6, 12 and 24
Disability (SAS)
Time frame: Months 1, 3, 6, 12 and 24
Change in Quality of life
Time frame: Months 1, 3, 6, 12 and 24
painkillers consumption
Time frame: Months 1, 3, 6, 12 and 24
Structural changes (X-Ray)
Time frame: Months 12 and 24
Structural changes (MRI)
Time frame: Months 12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 29507629Cosenza S, Toupet K, Maumus M, Luz-Crawford P, Blanc-Brude O, Jorgensen C, Noel D. Mesenchymal stem cells-derived exosomes are more immunosuppressive than microparticles in inflammatory arthritis. Theranostics. 2018 Feb 3;8(5):1399-1410. doi: 10.7150/thno.21072. eCollection 2018.
- Derived from this study: PubMed 40885690Pers YM, Schrezenmeier H, Fleury-Cappellesso S, Noth U, Rackwitz L, Ferreira R, Berenbaum F, Ruyssen-Witrand A, Thurlings RM, Addimanda O, Lisignoli G, Ramonda R, Shannon F, Punzi L, Baillet A, McCaskie AW, McDonnell S, O'Callaghan J, Turmezei T, Kessler DA, Lotfi R, Rojewski M, Duffy A, Finnerty A, Moisan A, Brochot-Dechet H, Aubery-Rousselet M, Michon A, Bouzas-Rodriguez J, Pullig O, Broussous S, Nogue E, Amico M, Picot MC, Barry F, Jorgensen C; ADIPOA2 consortium. Effect of intra-articular adipose-derived mesenchymal stromal cell versus placebo injection on pain and function in patients with knee osteoarthritis: the ADIPOA2 phase 2b randomised clinical trial. Ann Rheum Dis. 2025 Dec;84(12):2103-2114. doi: 10.1016/j.ard.2025.07.026. Epub 2025 Aug 29.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Christian Jorgensen, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injection (2x106 ASC/5ml). and Injection (10x106 ASC/5ml). in people with Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. 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?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement of pain or physical function (time frame: Month 6). 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 NCT02838069, which also lists 2 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 12 Jun 2026.