The Effects of Intra-articular Injection of Mesenchymal Stem Cells in Knee Joint Osteoarthritis
|ClinicalTrials.gov Identifier: NCT01504464|
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Biological: mesenchymal stem cell Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells in Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||October 2015|
Experimental: mesenchymal stem cell
Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection.
Biological: mesenchymal stem cell
intra articular injection of mesenchymal stem cell
Other Name: stem cell transplantation
The patients who are in control group and underwent placebo injection.
Patients with knee joint osteoarthritis who underwent intra articular placebo injection
- physical function improvement [ Time Frame: 2weeks ]Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection.
- change in pain density [ Time Frame: 2 weeks ]Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection.
- joint swelling [ Time Frame: 3months ]Evaluation the joint swelling by physical examination after intra articular cell injection.
- joint erythema [ Time Frame: 3months ]Evaluation the joint erythem by physical examination after cell injection
- deterioration of joint function [ Time Frame: 3months ]Evaluation the deterioration of joint function by physical examination after intra articular cell injection.
- Allergic reactions [ Time Frame: 3months ]Evaluation the allergic reactions like skin rash,skin erythema,dyspenea by physical examination after 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): NCT01504464
|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|