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

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00550524

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 I

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Amidotrizoic Acid Diatrizoate Diatrizoate meglumine Diatrizoate Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 1 Study of Bone Marrow - Derived Stem Cell for the Treatment of Knee Osteoarthritis

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: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of side-effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	5
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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

A: Experimental

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
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

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

Contacts

Contact: Fereydoun Davatchi, MD	(98-21) 8802-6956	fddh@davatchi.net
Contact: Bahar Sadeghi-Abdollahi, MD	(98-21) 8820-6956	bahar@bahars.net

Locations

Iran, Islamic Republic of
Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)	Recruiting
Tehran, Iran, Islamic Republic of, 14114
Contact: Fereydoun Davatchi, MD (98-21)8802-6956 fddh@davatchi.net
Principal Investigator: Fereydoun Davatchi, MD
Sub-Investigator: Bahar Sadeghi-Abdollahi, MD
Sub-Investigator: Masoomeh Akhlaghi, MD
Sub-Investigator: Tahereh Faezi, MD

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.

Responsible Party:	Rheumatology Research Center, Tehran University for Medical Sciences ( Fereydoun Davatchi, Head Rheumatology Research Center )
Study ID Numbers:	3087
Study First Received:	October 27, 2007
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00550524
Health Authority:	Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:

Knee osteoarthritis

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 15, 2009