Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint
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|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|
|Actual Primary Completion Date :||February 2011|
|Actual 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
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): 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|