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

Phase 1

Completed

• Conditions: Hip Osteoarthritis
• Interventions: Biological: cell injection

• Registration Number: NCT01500811
• Lead Sponsor: Royan Institute

Brief Summary

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

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.

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-03
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-28
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chondrocyte	cell injection	Patients with sever hip osteoarthritis who underwent intra articular cell injection.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quantitative changes in pain intensity	2 months	Evaluation the quantitative changes in pain measured by Visual Analogue Scale 2months after cell injection in compare with base line (before cell transplantation)
physical function improvement	2 months	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)
subchondral bone edema	2 months	Evaluation the subchondral bone edema by MRI after cell transplantation.
cartilage thickness	2 months	Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of