The Effects of Intra-articular Injection of Mesenchymal Stem Cells in Knee Joint Osteoarthritis
Osteoarthritis of the knee is one of the most common causes of disability among elderly. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in patients with severe knee osteoarthritis.
Biological: mesenchymal stem cell
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells in Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial|
- physical function improvement [ Time Frame: 2weeks ] [ Designated as safety issue: No ]Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection.
- change in pain density [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection.
- joint swelling [ Time Frame: 3months ] [ Designated as safety issue: Yes ]Evaluation the joint swelling by physical examination after intra articular cell injection.
- joint erythema [ Time Frame: 3months ] [ Designated as safety issue: Yes ]Evaluation the joint erythem by physical examination after cell injection
- deterioration of joint function [ Time Frame: 3months ] [ Designated as safety issue: Yes ]Evaluation the deterioration of joint function by physical examination after intra articular cell injection.
- Allergic reactions [ Time Frame: 3months ] [ Designated as safety issue: Yes ]Evaluation the allergic reactions like skin rash,skin erythema,dyspenea by physical examination after cell injection
|Study Start Date:||September 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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
This is single center, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. All subjects will undergo bone marrow aspiration. Mesenchymal stem cells will be isolated from bone marrow, cultured and transplanted back to the knee joint. Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo will be administered in this group 6 months after the first injection. Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed before and 6 months after the first injection by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale.
Please refer to this study by its ClinicalTrials.gov identifier: 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|