Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT01500811|
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : April 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hip Osteoarthritis||Biological: cell injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Patients with sever hip osteoarthritis who underwent intra articular cell injection.
Biological: cell injection
Intra articular injection of chondrocyte
Other Name: chondrocyte transplantation
- 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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|