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Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

NCT00550498 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-11-10

No results posted yet for this study

Summary

The purpose of this study is to find if autologous stem cell transplantation can stop the progression of intractable eye lesions of Behcet's Disease or even to improve it.

Conditions

  • Retinitis
  • Behcet's Syndrome

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 3-5 million cells, in a maximum volume of 0.3 ml. Cells will be injected in vitreal at 3.5 millimeter of limbus with a 26 gauge insulin needle.

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

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

  • Hormoz Shams, MD · Rheumatology Research Center, Medical Sciences/University of Tehran

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-07-31
Completion
2013-07-31

Countries

  • Iran

Study Locations

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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 NCT00550498 on ClinicalTrials.gov