Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

Study Overview
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Brief Summary
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Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip osteoarthritis

Detailed Description
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This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.

Official Title
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Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Biological: stem cell injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis diagnosed by MRI End stage osteoarthritis candidate for total hip 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: hip osteoarthritis<br>The patients with hip joint osteoarthritis who underwent cell injection | Biological: stem cell injection<br>* intra articular inection of mesenchymal stem cell<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| swelling of hip joint | Evaluatin the swelling of hip joint by physical examination after intra articular injection. | 2 months | 
| deterioration of joint function | Evaluation deterioration of joint function by physical examination after intra articular cell injection. | 2 months | 
| skin allergic reaction | Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection. | 1 week | 
| Respiratory reaction | Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative changes in pain intensity | Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection) | 2 months | 
| physical function improvement | Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score. | 2 months | 
| subchondral bone edema | Evaluation the subchondral bone edema by MRI | 2 months | 
| cartilage thickness | measuring the cartilage thickness after cell transplantation by MRI | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, hip joint, mesenchymal stem cell