Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis

Study Overview
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Brief Summary
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Hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and soft tissue linings. Patients have pain, stiffness, swelling, and difficulty walking. There are treatments available to help manage these symptoms like weight loss, and analgesics. Surgery is the appropriate treatment in patients who have failed these conservative treatments. The aim of this clinical study is to assess safety of autologous cultured chondrocyte intra-articular injection and obtain its clinical results in patients with severe hip osteoarthritis.

Detailed Description
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In this phase I clinical study 6 patients with severe hip osteoarthritis will be recruited. All patients will have a cartilage biopsy taken from the knee cartilage non-weight bearing zone. Chodrocytes will be extracted and cultured for 4 weeks. Patients then will receive chondrocyte injection under the guide of fluoroscopy. Patients will be evaluated post injection for 6 months at time intervals. Parameters considered being evaluated are, adverse effects, pain intensity and joint physical function and cartilage repair. These effects are measured by Visual Analogue Scale, WOMAC, Harris Hip Score questionnaire and MRI.

Official Title
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Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Biological: cell injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis diagnosed by MRI 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: 50 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: chondrocyte<br>Patients with sever hip osteoarthritis who underwent intra articular cell injection. | Biological: cell injection<br>* Intra articular injection of chondrocyte<br>* Other names: chondrocyte transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| joint swelling | Evaluation the swelling of hip joint after cell injection by physical examination. | 2 months | 
| deterioration of joint function | evaluation the deterioration of joint function by physical examination 2 months after injection in compare with base line(before injection) | 2 months | 
| dispenea | Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection. | 1 week | 
| skin rash | Evaluation the skin allergic reactions like skin rash by physical examination after cell injection. | 1 week | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chondrocyte hip osteoarthritis intra articular injection