MedTrace Logo

Stem Cell Transplantation for the Treatment of Knee Osteoarthritis

NCT00550524 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2010-11-22

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Fereydoun Davatchi, MD · Rheumatology Research Center, Medical Sciences/University of Teheran

  • Behrouz Nikbin, MD · Department of Immunology, Medical Sciences/University of Tehran

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00550524 on ClinicalTrials.gov