Retinitis Pigmentosa Clinical Trial
— RETICELLOfficial title:
Phase 2 Study Of Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa
Verified date | July 2017 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the short-term safety and efficacy of a single intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - diagnosis of retinitis pigmentosa logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse - visual Field less than 20 degreees Exclusion Criteria: - previous ocular surgery other than cataract - presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation - other ophthalmic disease like glaucoma and uveitis - previous history of blood disorders like leukemia - known allergy to fluorescein or indocyanine green - known coagulation abnormalities or current use of anticoagulative medication other than aspirin. |
Country | Name | City | State |
---|---|---|---|
Brazil | Centro de Pesquisa Rubens Siqueira | Sao Jose do Rio Preto | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Siqueira RC, Messias A, Messias K, Arcieri RS, Ruiz MA, Souza NF, Martins LC, Jorge R. Quality of life in patients with retinitis pigmentosa submitted to intravitreal use of bone marrow-derived stem cells (Reticell -clinical trial). Stem Cell Res Ther. 2015 Mar 14;6:29. doi: 10.1186/s13287-015-0020-6. — View Citation
Siqueira RC, Messias A, Voltarelli JC, Messias K, Arcieri RS, Jorge R. Resolution of macular oedema associated with retinitis pigmentosa after intravitreal use of autologous BM-derived hematopoietic stem cell transplantation. Bone Marrow Transplant. 2013 Apr;48(4):612-3. doi: 10.1038/bmt.2012.185. Epub 2012 Sep 24. — View Citation
Siqueira RC, Messias A, Voltarelli JC, Scott IU, Jorge R. Intravitreal injection of autologous bone marrow-derived mononuclear cells for hereditary retinal dystrophy: a phase I trial. Retina. 2011 Jun;31(6):1207-14. doi: 10.1097/IAE.0b013e3181f9c242. — View Citation
Siqueira RC. Stem cell therapy in retinal diseases? Rev Bras Hematol Hemoter. 2012;34(3):222-6. doi: 10.5581/1516-8484.20120054. — View Citation
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