Mesenchymal Stem Cells in Knee Cartilage Injuries

Study Overview
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Brief Summary
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Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.

Detailed Description
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Fourteen patients from both genders, age range 40-68, will be enrolled according to strict inclusion and exclusion criteria, divided into two equal groups based upon receiving autologous MSCs alone, or MSCs supported by platelet lysate through percutaneous injection. The patients are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee. The investigators hypothesize that the two groups will give satisfactory clinical outcomes, but the investigators are looking forward to assessing the best product that will activate chondrogenesis and heal cartilaginous injury.

Official Title
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Use of Mesenchymal Stem Cells for the Repair of Articular Cartilage Disorder of Knee Using Intra-articular Injection of Mesenchymal Cells Alone or Mesenchymal Cells With Platelet Lysate

Conditions
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Articular Cartilage Disorder of Knee, Osteoarthritis, Knee

Intervention / Treatment
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* Biological: Autologous Mesenchymal Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MRI must show moderate/severe articular injury Serum collagen II must be above the normal value. Lesion site: Femoral and Tibial condyles or patella Admission of steroid , NSAID, pain killers must be stopped before 1 month Exclusion Criteria: Lesion size PT and PTT not within normal value Complete blood count ( Hb, PCV, and RBC) not within the normal value HIV and Hepatitis Antigens (B and C) detection

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 68 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mesenchymal stem cells<br>Autologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury | Biological: Autologous Mesenchymal Stem Cells<br>* Comparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate<br>|
| Active Comparator: mesenchymal cells&platelet lysate<br>Autologous Mesenchymal Stem Cells primed prior to intra articular injection with platelet lysate into knees of patients with advanced articular cartilage injury | Biological: Autologous Mesenchymal Stem Cells<br>* Comparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product. | For every patient tests would be performed repeated at 6, and 12 months post-injection. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow derived Mesenchymal Stem Cells, Knee articular cartilage injury, Chondrogenesis, orthopedics