Osteoarthritis
Conditions
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.
Interventions
BIOLOGICALInjection (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.
BIOLOGICALInjection (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.
OTHERPlacebo
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.
Sponsors
University Hospital, Montpellier
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of pain or physical function | 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
| Measure | Time frame | Description |
|---|---|---|
| Disability (WOMAC) | Months 1, 3, 6, 12 and 24 | assessed by WOMAC questionnaire |
| Disability (KOOS) | Months 1, 3, 6, 12 and 24 | assessed by KOOS (Knee injury and Osteoarthritis Outcome Score questionnaire) |
| Disability (SAS) | Months 1, 3, 6, 12 and 24 | assessed by SAS questionnaire (The Short Arthritis Assessment Scale) |
| Change in Quality of life | Months 1, 3, 6, 12 and 24 | assessed by SF-36 questionnaire |
| painkillers consumption | Months 1, 3, 6, 12 and 24 | Changes from baseline (Day 0) to months 1, 3, 6, 12 and 24 in use of painkillers |
| Structural changes (X-Ray) | 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 |
| Structural changes (MRI) | Months 12 and 24 | Changes from baseline (Day 0) to months 12 and 24 by MOAKS (MRI Osteoarthritis Knee score) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORChristian Jorgensen, MD, PhD
University Hospital, Montpellier
Outcome results
None listed