Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis

Study Overview
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Brief Summary
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Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first. If unsuccessful, surgical options are considered. Stem cell therapy is one of the therapeutic options that can repair the damaged cartilage. Bone marrow derived mesenchymal stem cells have showed the capacity of bone and cartilage regeneration.

Detailed Description
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In this clinical study the investigators aim to investigate the safety of intra-articular injection of cultured autologous bone marrow derived mesenchymal stem cells (BM-MSCs) to the ankle joint in patients with severe ankle osteoarthritis. Patients will undergo bone marrow aspiration and will receive cultured BM-MSCs one month later. Patients will be assessed clinically with scoring system (FAO, VAS, WOMAC) preoperatively as well as 2 and 6 months postoperative to measure pain reduction and joint function improvement. Paraclinical studies (X-Ray and MRI) will be performed before and 6 months after treatment.

Official Title
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Phase 1 Study of Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Patients With Ankle Joint Osteoarteritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Biological: mesenchymal stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis diagnosed by MRI End stage osteoarthritis candidate for total ankle replacement Exclusion Criteria: Pregnancy or lactating Positive tests for HIV, HCV, HBV Active neurologic disorder End organ damage Uncontrolled endocrine disorder

Ages Eligible for Study
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Minimum Age: 18 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: stem cell recipient<br>patients with ankle joint osteoarthritis | Biological: mesenchymal stem cell<br>* intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis<br>* Other names: stem cell transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | Evaluate Safety of intra-articular injection of autologous cultured mesenchymal stem cells in patients with ankle osteoarthritis (time frame : baseline, 2 months, 6 months)by filling the check list of side effects | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | evaluation the pain reduction in patients with ankle joint osteoarthritis after stem cell transplantation by filling the SF36 | 6 months | 
| physical function | evaluation the ability of patient to standing,walking,climb the steps after stem cell transplantation. | 6 months | 
| defect | evaluation regeneration of ankle joint by serial MRI after stem cell transplantation based on changing the size of articular defect | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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side effect, mesenchymal stem cell, ankle, osteoarthritis