ADIPOA - Clinical Study
NCT01585857 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2022-12-23
Summary
Primary:
To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).
Secondary:
To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).
Conditions
Interventions
- BIOLOGICAL
-
Autologous adipose derived stem cells administrated for intra-articular use
Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues.
- BIOLOGICAL
-
Autologous adipose derived stem cells administrated for intra-articular use
Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. The first patient will be followed during 12 weeks before inclusion of the second patient.
Sponsors & Collaborators
-
University Hospital, Montpellier
lead OTHER
Principal Investigators
-
Christian Jorgensen, MD · University Hospital, Montpellier
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2014-12-31
- Completion
- 2014-12-31
Countries
- France
- Germany
Study Locations
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