Safety and efficacy of autologous stem cells derived from bone marrow in treating Osteoarthritis
- Registration Number
- CTRI/2010/091/001044
- Lead Sponsor
- International Stemcell Services Limited117, Venkateshwara Nagar, Jakkur, Bengaluru 560064
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 10
1. Must be able to give voluntary written (patients may not be able to write) consent.
2. Must be able to understand study information provided to him.
3. Age 30 to 70, inclusive
OA Kellgren and Lawrence classification 3 & 4
No ligamentous laxity i.e. stable
Ability to understand and willingness to sign consent form
The participant is able to comply with and understand the required visit schedule and all required tests and procedures.
Serious pre-existing medical conditions like Diabetes Mellitus, Chronic Renal Failure, Rheumatoid Arthritis, Collagen vascular diseases and Autoimmune diseases
Pregnant or lactating woman
Inflammatory arthritis
Oral steriod, methotrexate (immune suppressants)
History of drug or alcohol abuse or chronic smoking
Poor patient compliance
Infectious disease test positive for HIV 1&2, HbsAg, HCV and VDRL.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To establish safety of stem cell therapy in patients with osteoarthritis <br>2.To assess short and long term efficacy of stem cell therapy in OsteoarthritisTimepoint: 3 months, 6 months, 1 year
- Secondary Outcome Measures
Name Time Method Changes in the MRI knee with cartilage mapping and clinical improvement.Timepoint: 3 months, 6 months, 1 year