Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

This study has been terminated.
(No improvement obtained in 3 cases. Retinal detachment observed in 2 cases)
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00550498
First received: October 27, 2007
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Retinitis
Behcet's Syndrome
Biological: Autologous Stem Cell Transplantation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Bone Marrow - Derived Stem Cell in the Treatment of Ocular Lesions of Behcet's Disease

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 1- Visual acuity by ETDRS (Early Treatment of Diabetic Retinopathy Study). 2- Retinal state and retinal edema by Color Photography, Multifocal Electroretinography, and OCT (Optic Coherent Tomography). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: December 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Behcet's Disease with ocular lesions
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.

Detailed Description:

To test in a pilot study the effect of autologous stem cell transplantation in stopping the progression of retinal damage of eye lesions in Behcet's Disease by repairing the vascular damage, and possibly to improve the lesions.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Behcet's Disease
  • Fulfilling the International Criteria for behcet's Disease (ICBD)
  • Ocular lesions with retinal vasculitis
  • Resistant to at least 3 months of combination therapy with pulse cyclophosphamide (1g/monthly), azathioprine (3 mg/kg/daily), and prednisolone 0.5 mg/kg/daily
  • Visual acuity not less than 4 meters finger count
  • Retinal edema confirmed by color photography and OCT

Exclusion Criteria:

  • No Vision
  • Active posterior uveitis
  • Fundus not visible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550498

Locations
Iran, Islamic Republic of
Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Fereydoun Davatchi, MD Rheumatology Research Center, Medical Sciences/University of Teheran
Principal Investigator: Hormoz Shams, MD Rheumatology Research Center, Medical Sciences/University of Tehran
Principal Investigator: Behrouz Nikbin, MD Department of Immunology, Medical Sciences/University of Tehran
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences
ClinicalTrials.gov Identifier: NCT00550498     History of Changes
Other Study ID Numbers: 3086
Study First Received: October 27, 2007
Last Updated: July 25, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
Retinal Vasculitis
Retinal Edema
Behcet's Disease

Additional relevant MeSH terms:
Behcet Syndrome
Cardiovascular Diseases
Eye Diseases
Mouth Diseases
Panuveitis
Skin Diseases
Skin Diseases, Vascular
Stomatognathic Diseases
Uveal Diseases
Uveitis
Uveitis, Anterior
Vascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on October 23, 2014