Use of Adipose Tissue Derived Mesenchymal Stem Cells for Knee Osteoarthrosis

Study Overview
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Brief Summary
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Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed with Knee osteoarthrosis

Detailed Description
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Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to specific inclusion and exclusion criteria. These patients will be injected with Adipose Tissue derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.

Official Title
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Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Adipose Tissue Derived Mesenchymal Stem Cells (ATMSC) for Advanced Stage III and IV KOA

Conditions
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Knee Osteoarthrosis

Intervention / Treatment
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* Biological: Adipose tissue derived mesenchymal stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe KOA stage III or IV by Laurance & Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint. Willing to participate by signing the informed consent Exclusion Criteria: Sublaxation beyond 20 degrees of the bones of the knee joint Oral anticoagulants or heparin therapy Heart failure or arrhythmia Body Mass Index > 35 Uncontrolled Diabetes Mellitus. Evidence of Infectious Diseases. Active infection Malignancy Pregnancy Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000. Unreliable patients Non-resident in Jordan

Ages Eligible for Study
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Minimum Age: 42 Years
Maximum Age: 75 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: adipose tissue mesenchymal stem cell<br>Intra-articular adipose tissue derived mesenchymal stem cell injection will be given for each patient in 2 doses, 50 million of ATMSC in each dose | Biological: Adipose tissue derived mesenchymal stem cell<br>* Intra-articular adipose tissue derived mesenchymal stem cell injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the safety and tolerability of the intra articular injection | patients will be monitored for any adverse events resulting from the intraarticular injection of ATMSC | Time Frame: 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the efficacy of intra-articular injection of ATMSC | The efficacy of the intra-articular injection of ATMSC will be assessed by Magnetic Resonance Imaging (MRI). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthrosis, knee, adipose tissue, stem cells, cell therapy