Status:
UNKNOWN
Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis
Lead Sponsor:
National University of Malaysia
Collaborating Sponsors:
Cytopeutics Pte. Ltd.
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Osteoarthritis is a progressively degenerative disease resulting in increasing pain, impairment and ultimately disability. While the available treatments seek to ameliorate pain or improve mobility, t...
Eligibility Criteria
Inclusion
- Diagnosed with mild to moderate osteoarthritis based on Kellgren-Lawrence radiographic classification
- Has a history of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage
Exclusion
- Has systemic bone or cartilage disorders
- Has significant vascular impairment proximal to implant site
- Has substantial joint destabilization including extensive osteophyte formation
- Has substantial surface erosion of the weight-bearing articular cartilage
- Evidence of infection or fractures in or around the joint
- Contraindication to bone marrow aspiration
- Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- Any past history of neoplasia and primary hematological disease
- Renal impairment indicated by serum creatinine greater than 200mM
- Liver impairment indicated by serum aspartate transaminase and serum alanine transaminase greater than 120 IU
- Any other co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01459640
Start Date
March 1 2011
End Date
March 1 2014
Last Update
October 25 2011
Active Locations (1)
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1
UKM Medical Centre
Kuala Lumpur, Malaysia, 56000