Knee Osteoarthritis
Conditions
Keywords
Knee osteoarthritis
Brief summary
The purpose of this study is to find if autologous stem cell transplantation can improve clinical manifestations of knee osteoarthritis.
Interventions
BIOLOGICALAutologous Stem Cell Transplantation
Autologous bone marrow aspiration (20 ml) from iliac crest. Separation of mononuclear cells using ficoll hypaque and culture in 10% fetal bovine serum and Dulbecco modified eagles medium. After confluent stage, detachment of cells with trypsin/EDTA, and subculture. Repeated passages until obtainment of required cell number. Confluent cells of last passage are washed with tyrode solution and incubate with M199 for 60 minutes. Cells are separated using trypsin/EDTA and washed 3 times with M199 and 1% HSA. Precipitate will be diluted with heparinized M199 to make solution with 6×106 cells /ml. Sample will be tested for viability and detection of CD45, CD34, CD90, CD44, CD13, CD105, and CD166 before injection. The number of cells for injection will be between 20-25 million cells; in a maximum volume of 4-6 ml. Cells will be injected in the knee joint with a 21 gauge needle.
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Moderate bilateral knee osteoarthritis
Exclusion criteria
* No infectious or inflammatory arthritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1- Comparison of pain in the injected knee with the controlateral knee 2- Comparison of joint motion of the injected knee with the controlateral knee | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of side-effects | 12 months |
Countries
Iran
Outcome results
None listed