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No improvement obtained in 3 cases. Retinal detachment observed in 2 cases
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Behcet's Disease with ocular lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital) | Tehran | Tehran Province | 14114 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15372100 | Background | 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. | |
| 12944502 | Background |
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| ID | Term |
|---|---|
| D012173 | Retinitis |
| D001528 | Behcet Syndrome |
| D031300 | Retinal Vasculitis |
| D010211 | Papilledema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| 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. |
| 12077603 | 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. |
| 23773637 | Derived | 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. |
| D014606 |
| Uveitis, Anterior |
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |