Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

NCT ID: NCT00550498

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2013-07-31

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.

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.

Conditions

Retinitis; Behcet's Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Behcet's Disease with ocular lesions

Group Type: EXPERIMENTAL

Autologous Stem Cell Transplantation

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fereydoun Davatchi, MD

Role: STUDY_CHAIR

Rheumatology Research Center, Medical Sciences/University of Teheran

Hormoz Shams, MD

Role: PRINCIPAL_INVESTIGATOR

Rheumatology Research Center, Medical Sciences/University of Tehran

Behrouz Nikbin, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Immunology, Medical Sciences/University of Tehran

Locations

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

Tehran, Tehran Province, Iran

Countries

Iran

References

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.

Reference Type: BACKGROUND

PMID: 15372100 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12944502 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12077603 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23773637 (View on PubMed)

Other Identifiers

3086

Identifier Type: -

Identifier Source: org_study_id