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Completed

NCT Number: NCT02838069

A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UH Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Placebo

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Disability (WOMAC)

    Time frame: Months 1, 3, 6, 12 and 24

    assessed by WOMAC questionnaire

  2. Disability (KOOS)

    Time frame: Months 1, 3, 6, 12 and 24

    assessed by KOOS (Knee injury and Osteoarthritis Outcome Score questionnaire)

  3. Disability (SAS)

    Time frame: Months 1, 3, 6, 12 and 24

    assessed by SAS questionnaire (The Short Arthritis Assessment Scale)

  4. Change in Quality of life

    Time frame: Months 1, 3, 6, 12 and 24

    assessed by SF-36 questionnaire

  5. painkillers consumption

    Time frame: Months 1, 3, 6, 12 and 24

    Changes from baseline (Day 0) to months 1, 3, 6, 12 and 24 in use of painkillers

  6. Structural changes (X-Ray)

    Time frame: Months 12 and 24

    Changes from baseline (Day 0) to months 12 and 24 in femorotibial joint space of the index knee on X-ray

  7. Structural changes (MRI)

    Time frame: Months 12 and 24

    Changes from baseline (Day 0) to months 12 and 24 by MOAKS (MRI Osteoarthritis Knee score)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Aries srl (ARIES)
  • Assistance Publique - Hôpitaux de Paris
  • Cambridge University Hospitals NHS Foundation Trust
  • Centre National de la Recherche Scientifique, France
  • EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH (EWK)
  • Etablissement Français du Sang
  • European Clinical Research Infrastructure Network
  • HUMAN MED AG (HM)
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Istituto Ortopedico Rizzoli
  • National University of Ireland, Galway, Ireland
  • PINTAIL LTD (PT)
  • SPORTS SURGERY CLINIC LIMITED
  • Stichting Katholieke Universiteit
  • University Hospital, Toulouse
  • University of Padova
  • University of Ulm

Registry information

Official study 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

Acronym: ADIPOA-2

Important dates

Study start
2016
Primary completion
2022
Study completion
2024
First posted
Jul 20, 2016
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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