Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Alexandra Cristina Senegaglia
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in WOMAC (Western Ontario and McMaster Universities)score
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 cartilage defects.
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 conventional treatments seek to ameliorate pain or improve mobility. However, these treatments rarely modify the course of the disease.Recent studies cell-based have shown encouraging results in both animal studies and a few human case reports. We designed a study to assess the safety and efficacy of osteoarthritis treatment with intra-articular injection of autologous bone marrow-derived mesenchymal stem cells.
Investigators
Alexandra Cristina Senegaglia
PhD
Pontifícia Universidade Católica do Paraná
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Change in WOMAC (Western Ontario and McMaster Universities)score
Time Frame: 3 months, 6 months, 9 months, 12 months
Secondary Outcomes
- Change from baseline in cartilage thickness at 6 months by MRI(6 months)
- Knee pain relief (WOMAC and Lequesne scores)(3 months, 6 months, 12 months)
- Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)(12 months)