Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis
Sponsor: University Hospital, Montpellier
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.
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
Key Details
Gender
All
Age Range
45 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2016-09-20
Completion Date
2024-03
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
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.
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
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.
Locations (1)
UH Montpellier
Montpellier, France