Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis|
- joint swelling [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Evaluation the swelling of hip joint after cell injection by physical examination.
- deterioration of joint function [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.
- skin rash [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Evaluation the skin allergic reactions like skin rash by physical examination after cell injection.
- Quantitative changes in pain intensity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Evaluation the subchondral bone edema by MRI after cell transplantation.
- cartilage thickness [ Time Frame: 2 months ] [ Designated as safety issue: No ]Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)
|Study Start Date:||March 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Patients with sever hip osteoarthritis who underwent intra articular cell injection.
Biological: cell injection
Intra articular injection of chondrocyte
Other Name: chondrocyte transplantation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500811
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||Nasser Aghdami, MD,PhD||Head of Royan Cell therapy Center|
|Principal Investigator:||Mohsen Emadeddin, MD||scientist|