Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

NCT00550498 | Terminated Phase 1 DMC

• 1 other identifier: 3086
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Retinal Vasculitis; Retinal Edema; Behcet's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

A

EXPERIMENTAL

Behcet's Disease with ocular lesions

Biological: Autologous Stem Cell Transplantation

Interventions

Autologous Stem Cell Transplantation BIOLOGICAL

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.

A

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No Vision
• Active posterior uveitis
• Fundus not visible

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

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

Tehran, Tehran Province, 14114, Iran

Location

Related Publications (4)

• 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. doi: 10.1172/JCI21686.

  PMID: 15372100 BACKGROUND

• 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. doi: 10.1523/JNEUROSCI.23-21-07742.2003.

  PMID: 12944502 BACKGROUND

• 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. doi: 10.1038/nature00870. Epub 2002 Jun 20.

  PMID: 12077603 BACKGROUND

• Davatchi F, Nikbin B, Shams H, Sadeghi Abdollahi B, Mohyeddin M, Shahram F. Mesenchymal stem cell therapy unable to rescue the vision from advanced Behcet's disease retinal vasculitis: report of three patients. Int J Rheum Dis. 2013 Apr;16(2):139-47. doi: 10.1111/1756-185X.12068.

  PMID: 23773637 DERIVED

MeSH Terms

Conditions

Retinitis; Behcet Syndrome; Retinal Vasculitis; Papilledema

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Fereydoun Davatchi, MD

  Rheumatology Research Center, Medical Sciences/University of Teheran

  STUDY CHAIR

• Hormoz Shams, MD

  Rheumatology Research Center, Medical Sciences/University of Tehran

  PRINCIPAL INVESTIGATOR

• Behrouz Nikbin, MD

  Department of Immunology, Medical Sciences/University of Tehran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2007
• First Posted: October 30, 2007
• Study Start: December 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

IR (1)