Back to resultsStem Cell Transplantation for the Treatment of Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Autologous Stem Cell Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Moderate bilateral knee osteoarthritis
Exclusion Criteria:
- No infectious or inflammatory arthritis
Sites / Locations
- Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Knee osteoarthritis
Outcomes
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
Secondary Outcome Measures
Evaluation of side-effects
Full Information
NCT ID
NCT00550524
First Posted
October 27, 2007
Last Updated
November 19, 2010
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00550524
Brief Title
Stem Cell Transplantation for the Treatment of Knee Osteoarthritis
Official Title
Phase 1 Study of Bone Marrow - Derived Stem Cell for the Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find if autologous stem cell transplantation can improve clinical manifestations of knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Knee osteoarthritis
Intervention Type
Biological
Intervention Name(s)
Autologous Stem Cell Transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evaluation of side-effects
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate bilateral knee osteoarthritis
Exclusion Criteria:
No infectious or inflammatory arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fereydoun Davatchi, MD
Organizational Affiliation
Rheumatology Research Center, Medical Sciences/University of Teheran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Behrouz Nikbin, MD
Organizational Affiliation
Department of Immunology, Medical Sciences/University of Tehran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
11998164
Citation
Le Blanc K. [Mesenchymal stem cells. Basic science and future clinical use]. Lakartidningen. 2002 Mar 21;99(12):1318-21, 1324. Swedish.
Results Reference
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PubMed Identifier
1870029
Citation
Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504.
Results Reference
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PubMed Identifier
9308548
Citation
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.
Results Reference
background
PubMed Identifier
15280587
Citation
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. doi: 10.1385/1-59259-810-2:053.
Results Reference
background
PubMed Identifier
17620285
Citation
Caplan AI. Adult mesenchymal stem cells for tissue engineering versus regenerative medicine. J Cell Physiol. 2007 Nov;213(2):341-7. doi: 10.1002/jcp.21200.
Results Reference
background
PubMed Identifier
21518322
Citation
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.
Results Reference
derived
Learn more about this trial
Stem Cell Transplantation for the Treatment of Knee Osteoarthritis
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