NCT01500811

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	cell injection	Intra articular injection of chondrocyte

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-12-28
• Last updated: 2014-04-28

Locations

1 site across 1 country: Iran