Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

Retinitis Clinical Trial

Official title:

Phase 1 Study of Bone Marrow - Derived Stem Cell in the Treatment of Ocular Lesions of Behcet's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00550498
• Other study ID #: 3086
• Status: Terminated
• Phase: Phase 1
• First received: October 27, 2007
• Last updated: November 9, 2015
• Start date: December 2007
• Est. completion date: July 2013

Study information

• Verified date: November 2015
• 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 stop the progression of intractable eye lesions of Behcet's Disease or even to improve it.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Syndrome
• Retinitis

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 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.

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 (3)

Jiang Y, Jahagirdar BN, Reinhardt RL, Schwartz RE, Keene CD, Ortiz-Gonzalez XR, Reyes M, Lenvik T, Lund T, Blackstad M, Du J, Aldrich S, Lisberg A, Low WC, Largaespada DA, Verfaillie CM. Pluripotency of mesenchymal stem cells derived from adult marrow. Nature. 2002 Jul 4;418(6893):41-9. Epub 2002 Jun 20. Erratum in: Nature. 2007 Jun 14;447(7146):879-80. — View Citation

Kicic A, Shen WY, Wilson AS, Constable IJ, Robertson T, Rakoczy PE. Differentiation of marrow stromal cells into photoreceptors in the rat eye. J Neurosci. 2003 Aug 27;23(21):7742-9. — View Citation

Otani A, Dorrell MI, Kinder K, Moreno SK, Nusinowitz S, Banin E, Heckenlively J, Friedlander M. Rescue of retinal degeneration by intravitreally injected adult bone marrow-derived lineage-negative hematopoietic stem cells. J Clin Invest. 2004 Sep;114(6):765-74. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		12 months	Yes