Status:
COMPLETED
Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair
Lead Sponsor:
Alexandra Cristina Senegaglia
Collaborating Sponsors:
Pontifícia Universidade Católica do Paraná
Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil
Conditions:
Osteoarthritis
Eligibility:
All Genders
25-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a non-randomized study aimed to determine the safety and efficacy of intra-articular injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee articular cartilag...
Detailed Description
Osteoarthritis is the most prevalent joint disease, create articular cartilage defects is a frequent cause of joint pain, functional loss, and disability. Osteoarthritis often becomes chronic, and con...
Eligibility Criteria
Inclusion
- Diagnosed with mild to moderate osteoarthritis (visual analogue scale)
- History of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage
Exclusion
- Any past history of neoplasia and primary hematological disease
- Autoimmune disease or the medical history
- Systemic bone or cartilage disorders
- Acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- Co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy
- Evidence of infection or fractures in or around the joint
- Contraindication to bone marrow aspiration
- Deviation from the axial axis (varus or valgus) greater than 12 degrees.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01895413
Start Date
September 1 2012
End Date
January 1 2016
Last Update
December 13 2017
Active Locations (1)
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1
Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, Brazil, 80215-901