Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint
|ClinicalTrials.gov Identifier: NCT01499056|
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : December 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hip Osteoarthritis||Biological: stem 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 Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint|
|Study Start Date :||June 2010|
|Primary Completion Date :||February 2011|
|Study Completion Date :||March 2011|
Experimental: hip osteoarthritis
The patients with hip joint osteoarthritis who underwent cell injection
Biological: stem cell injection
intra articular inection of mesenchymal stem cell
- swelling of hip joint [ Time Frame: 2 months ]Evaluatin the swelling of hip joint by physical examination after intra articular injection.
- deterioration of joint function [ Time Frame: 2 months ]Evaluation deterioration of joint function by physical examination after intra articular cell injection.
- skin allergic reaction [ Time Frame: 1 week ]Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.
- Respiratory reaction [ Time Frame: 1 week ]Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.
- Quantitative changes in pain intensity [ Time Frame: 2 months ]Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection)
- physical function improvement [ Time Frame: 2 months ]Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.
- subchondral bone edema [ Time Frame: 2 months ]Evaluation the subchondral bone edema by MRI
- cartilage thickness [ Time Frame: 2 months ]measuring the cartilage thickness after cell transplantation by MRI
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499056
|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|