Status:
UNKNOWN
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Osteoarthritis
Lead Sponsor:
International Stemcell Services Limited
Conditions:
Osteoarthritis
Eligibility:
All Genders
30-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Osteoarthritis is a leading cause of chronic disability in elderly and the risk of disability attributed to osteoarthritis is as great as or greater than due to any other medical condition in that age...
Eligibility Criteria
Inclusion
- Must be able to give voluntary written (patients may not be able to write) consent.
- Must be able to understand study information provided to him.
- 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.
Exclusion
- 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 steroid, 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01152125
Start Date
January 1 2010
End Date
January 1 2012
Last Update
June 9 2011
Active Locations (1)
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1
St. Theresa's Hospital
Bengaluru, Karnataka, India, 560010