Clinical trial NCT00550498: Stem Cell Transplantation in Ocular Lesions of Behcet's Disease
Official title: Phase 1 Study of Bone Marrow - Derived Stem Cell in the Treatment of Ocular Lesions of Behcet's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Retinitis
Behcet's Syndrome
Keywords: Retinal Vasculitis
Retinal Edema
Behcet's Disease
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 5
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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).
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
Study officials:
affiliation: Rheumatology Research Center, Medical Sciences/University of Teheran
name: Fereydoun Davatchi, MD
role: STUDY_CHAIR
affiliation: Rheumatology Research Center, Medical Sciences/University of Tehran
name: Hormoz Shams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Immunology, Medical Sciences/University of Tehran
name: Behrouz Nikbin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1172/JCI21686.
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. doi: 10.1523/JNEUROSCI.23-21-07742.2003.
citation: 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.
citation: 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.