ADIPOA 2
Research type
Research Study
Full 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.
IRAS ID
196188
Contact name
Andrew McCaskie
Contact email
Sponsor organisation
CHU Montpellier
Eudract number
2015-002125-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 25 months, 0 days
Research summary
Background: Osteoarthritis (OA) is an incurable disease. Due to the destruction of the articular cartilage, normal joint function is no longer possible and causes pain. Since articular cartilage is not renewing in adults, it is expected that the disease will further progress. Medicinal treatments using drugs and/or physical therapy help here only soothing, but do not affect the causes of OA. Since OA is increasing in prevalence, it is necessary to gain new insights into the efficacy and tolerability of new therapeutic options.
Study method: The body’s own stem cells are isolated from the fat tissue (adipose derived mesenchymal stromal cells (ASC)), by a limited digestion of the adipose tissue. After culturing these cells for several days, they are injected into the knee joint. These cells have anti-inflammatory properties and have the ability to form cartilage tissue, or may induce the formation of cartilage. Therefore, we want to investigate the efficacy of a single intra-articular injection of ASC in mild to moderate knee OA, based on improvement of pain and function compared to placebo.
Study population: A total of 150 patients will be enrolled in the study. These subjects can be male and female between the ages of 45 to 70 years with diagnosis of mild to moderate medial and/or external femorotibial knee OA. This clinical trial will be performed in 10 trial centres in Europe. On behalf of the sponsor, the trial site in UK will involve about 15 patients. All patients will be randomized in 3 groups: 1) 50 patients will receive placebo; 2) 50 patients will receive 2x106 cellules; 3) 50 patients will receive 10x106 cellules. The patients will be followed during 25 months.
Funding: This study is financed by the H2020 Programme of the European Union (grant: ADIPOA-2: n°643809).
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/1981
Date of REC Opinion
31 Jan 2017
REC opinion
Further Information Favourable Opinion