Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis

Study Overview
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Brief Summary
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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, these treatments rarely modify the course of the disease, but rather attend to its consequences. For early stage osteoarthritis, treatment is largely limited to addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs). These drugs do not stop the progression of the condition or regenerates damaged cartilage. This is a randomized and open labelled study aimed to determine the efficacy of intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in patients with mild to moderate osteoarthritis.

Official Title
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Phase 2 Study Assessing the Efficacy of Intra-Articular Autologous Mesenchymal Stem Cells in Patients With Mild to Moderate Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Hyaluronic Acid
* Biological: Autologous bone marrow-derived mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyaluronic acid<br> | Drug: Hyaluronic Acid<br>* Intra-articular injection; 30mg/2ml; three-weekly injection regimen<br>* Other names: Orthovisc;|
| Experimental: Bone marrow mesenchymal stem cells<br>Autologous bone marrow-derived mesenchymal stem cells | Biological: Autologous bone marrow-derived mesenchymal stem cells<br>* Single intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in hyaluronic acid Orthovisc (3rd injection in a three-weekly injection regimen)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in cartilage thickness at 12 months by MRI |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score |  | 1 month, 3 months, 6 months, 9 months, 12 months | 
| IKDC Subjective Knee Evaluation Form (2000) |  | 1 month, 3 months, 6 months, 9 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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Osteoarthritis, Bone marrow, Mesenchymal stem cells, Autologous, Mild osteoarthritis, Moderate osteoarthritis