Stem Cell Transplantation for the Treatment of Knee Osteoarthritis - Full Text View

Purpose

The purpose of this study is to find if autologous stem cell transplantation can improve clinical manifestations of knee osteoarthritis.

Condition	Intervention	Phase
Knee Osteoarthritis	Biological: Autologous Stem Cell Transplantation	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 1 Study of Bone Marrow - Derived Stem Cell for the Treatment of Knee Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of side-effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	5
Study Start Date:	December 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Knee osteoarthritis	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.

Arms

Assigned Interventions

Experimental: A

Knee osteoarthritis

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.

Eligibility


Ages Eligible for Study:	40 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Moderate bilateral knee osteoarthritis

Exclusion Criteria:

No infectious or inflammatory arthritis

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550524

Locations


Iran, Islamic Republic of
Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
Tehran, Iran, Islamic Republic of, 14114

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators


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

More Information

Publications:

Le Blanc K. [Mesenchymal stem cells. Basic science and future clinical use]. Lakartidningen. 2002 Mar 21;99(12):1318-21, 1324. Review. Swedish.

Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50.

Caplan AI, Elyaderani M, Mochizuki Y, Wakitani S, Goldberg VM. Principles of cartilage repair and regeneration. Clin Orthop Relat Res. 1997 Sep;(342):254-69.

Solchaga LA, Welter JF, Lennon DP, Caplan AI. Generation of pluripotent stem cells and their differentiation to the chondrocytic phenotype. Methods Mol Med. 2004;100:53-68.

Caplan AI. Adult mesenchymal stem cells for tissue engineering versus regenerative medicine. J Cell Physiol. 2007 Nov;213(2):341-7. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Davatchi F, Abdollahi BS, Mohyeddin M, Shahram F, Nikbin B. Mesenchymal stem cell therapy for knee osteoarthritis. Preliminary report of four patients. Int J Rheum Dis. 2011 May;14(2):211-5. doi: 10.1111/j.1756-185X.2011.01599.x. Epub 2011 Mar 4.


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
Study First Received:	October 27, 2007
Last Updated:	November 19, 2010
Health Authority:	Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:


Knee osteoarthritis

Additional relevant MeSH terms:


Osteoarthritis Osteoarthritis, Knee Arthritis	Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

ClinicalTrials.gov processed this record on September 29, 2016