Stem Cell Transplantation for the Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Phase 1 Study of Bone Marrow - Derived Stem Cell for the Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00550524
• Other study ID #: 3087
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: October 27, 2007
• Last updated: November 19, 2010
• Start date: December 2007
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Moderate bilateral knee osteoarthritis

Exclusion Criteria:

• No infectious or inflammatory arthritis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (5)

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. — View Citation

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

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation of side-effects		12 months	Yes