NCT00550524

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_1 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 22, 2010

Status Verified

November 1, 2010

Enrollment Period

2.9 years

First QC Date

October 27, 2007

Last Update Submit

November 19, 2010

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Evaluation of side-effects

    12 months

Study Arms (1)

A

EXPERIMENTAL

Knee osteoarthritis

Biological: Autologous Stem Cell Transplantation

Interventions

Autologous Stem Cell TransplantationBIOLOGICAL

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.

A

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate bilateral knee osteoarthritis

You may not qualify if:

  • No infectious or inflammatory arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)

Tehran, Tehran Province, 14114, Iran

Location

Related Publications (6)

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

    PMID: 11998164BACKGROUND

  • Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504.

    PMID: 1870029BACKGROUND

  • 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.

    PMID: 9308548BACKGROUND

  • 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.

    PMID: 15280587BACKGROUND

  • 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.

    PMID: 17620285BACKGROUND

  • 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.

    PMID: 21518322DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Fereydoun Davatchi, MD

    Rheumatology Research Center, Medical Sciences/University of Teheran

    STUDY CHAIR

  • Behrouz Nikbin, MD

    Department of Immunology, Medical Sciences/University of Tehran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2007

First Posted

October 30, 2007

Study Start

December 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 22, 2010

Record last verified: 2010-11

Locations

IR(1)