NCT02838069

Brief 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), 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

6 years

First QC Date

June 13, 2016

Last Update Submit

September 24, 2025

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

    Month 6

Secondary Outcomes (7)

  • Disability (WOMAC)

    Months 1, 3, 6, 12 and 24

  • Disability (KOOS)

    Months 1, 3, 6, 12 and 24

  • Disability (SAS)

    Months 1, 3, 6, 12 and 24

  • Change in Quality of life

    Months 1, 3, 6, 12 and 24

  • painkillers consumption

    Months 1, 3, 6, 12 and 24

  • +2 more secondary outcomes

Study Arms (3)

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.

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.

Biological: Injection (10x106 ASC/5ml).

Placebo

PLACEBO COMPARATOR

0.5% glucose in saline with 4.5% albumin

Other: Placebo

Interventions

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.

2x106 ASC intra-articular injection
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.

10x106 ASC intra-articular injection
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.

Placebo

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • Pers 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.

    PMID: 40885690DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Injections

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Christian Jorgensen, MD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

July 20, 2016

Study Start

September 20, 2016

Primary Completion

September 1, 2022

Study Completion

March 1, 2024

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)