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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Jul 15, 2016

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a single injection of special cells called autologous adipose-derived mesenchymal stromal cells (ASCs) in patients suffering from knee osteoarthritis (OA). Osteoarthritis is a condition that causes pain and stiffness in the joints, and this study aims to see if these cells can help improve the condition better than a standard treatment (placebo). Researchers will check how well the treatment works and how safe it is by using MRI scans after one and two years.

To be eligible for this trial, participants must have mild to moderate knee osteoarthritis and experience pain for at least half of the days in the month leading up to the study. They should not have received certain treatments like injections for their knee in the past six months and should not have had significant injuries or surgeries to the knee recently. This study is currently active but not recruiting new participants, and it includes individuals aged between 16 and 39 years, regardless of gender. Participants will receive either the ASC treatment or a placebo, and they can expect close monitoring of their progress throughout the study.

Gender

ALL

Eligibility criteria

• 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

Trial Officials