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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Royan Institute

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quantitative changes in pain intensity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 months ]
    Evaluation the subchondral bone edema by MRI after cell transplantation.
  • cartilage thickness [ Time Frame: 2 months ]
    Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)


Original Secondary Outcome: Same as current

Information By: Royan Institute

Dates:
Date Received: December 22, 2011
Date Started: March 2011
Date Completion:
Last Updated: April 24, 2014
Last Verified: January 2011