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MSV Allogenic Stem Cells for Knee Osteoarthritis
NCT01586312Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2012
- Primary completion
- Dec 2013
- Countries
- 1
- Sponsor
- Red de Terapia Celular
- Modality
- Stem Cell Therapies
- Drugs
- MSV
- Conditions
- osteoarthritis (OA)
01
Overview
Phase 2, randomised, double-blind trial of MSV in osteoarthritis (OA) (2 arms), sponsored by Red de Terapia Celular. Primary endpoint: Number of Participants With Adverse Events as a Measure of Safety and Tolerability at 1 year. Started Apr 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
MSV
Intra-articular injection of 40 million allogenic MSCs
Hyaluronic Acid
Intra-articular injection of 60 mg hyaluronic acid
03
Who it enrols
Patients with knee osteoarthritis grade II-IV, chronic pain, BMI <= 30.5, and no recent intra-articular injections.
04
Endpoints
Primary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Secondary
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)
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