Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Bone marrow aspiration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cells<br>Bone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells | Procedure: Bone marrow aspiration<br>* Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WOMAC (Western Ontario and McMaster Universities)score |  | 3 months, 6 months, 9 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cartilage injury, Osteoarthritis, Mesenchymal stem cells