Stem Cell Transplantation for the Treatment of Knee Osteoarthritis
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ClinicalTrials.gov Identifier: NCT00550524 |
Recruitment Status
: Unknown
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was: Enrolling by invitation
First Posted
: October 30, 2007
Last Update Posted
: November 22, 2010
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Condition or disease | Intervention/treatment | Phase |
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Knee Osteoarthritis | Biological: Autologous Stem Cell Transplantation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1 Study of Bone Marrow - Derived Stem Cell for the Treatment of Knee Osteoarthritis |
Study Start Date : | December 2007 |
Estimated Primary Completion Date : | November 2010 |
Estimated Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Knee osteoarthritis
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Biological: Autologous 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.
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- 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 [ Time Frame: 12 months ]
- Evaluation of side-effects [ Time Frame: 12 months ]

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Moderate bilateral knee osteoarthritis
Exclusion Criteria:
- No infectious or inflammatory arthritis

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): NCT00550524
Iran, Islamic Republic of | |
Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital) | |
Tehran, Iran, Islamic Republic of, 14114 |
Study Chair: | Fereydoun Davatchi, MD | Rheumatology Research Center, Medical Sciences/University of Teheran | |
Principal Investigator: | Behrouz Nikbin, MD | Department of Immunology, Medical Sciences/University of Tehran |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00550524 History of Changes |
Other Study ID Numbers: |
3087 |
First Posted: | October 30, 2007 Key Record Dates |
Last Update Posted: | November 22, 2010 |
Last Verified: | November 2010 |
Keywords provided by Tehran University of Medical Sciences:
Knee osteoarthritis |
Additional relevant MeSH terms:
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |