A Phase 1 interventional study of intravitreal injection of autologous bone marrow stem cells in Retinitis Pigmentosa, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-20.
Sponsored by University of Sao Paulo · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the short-term safety of a single intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.
A prospective phase I, nonrandomized open-label study of retinitis pigmentosa patients with best-corrected ETDRS visual acuity (BCVA) worse than 20/200. Standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . Three measures will be used to evaluate the short-term safety of intravitreal of ABMDSC: 1) severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale; 2) decrease in ERG response; 3) decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+ for more than 1 month after injection according to a classification described elsewhere ; 2) decrease in CMT more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. Secondary outcome measures will be used to evaluate the short-term efficiency of intravitreal of ABMDSC: 1) improvement in ERG response; 2) increase in visual field: 3) increase in CSMT > 50um and not related to macular edema; 4) increase > 5 letters on BCVA
273 studies on the registry are indexed under Retinitis Pigmentosa; 71 are open to participants now.
This study's enrollment of 5 is below the median of 27 across 177 interventional studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →University of Sao Paulo is the lead sponsor of 1,032 studies on the registry; 93 are open to participants now.
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open-label study of retinitis pigmentosa patients with best-corrected visual acuity (BCVA) worse than 20/200.
Biological: intravitreal injection of autologous bone marrow stem cells
One intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure.
Also known as: Autologous bone marrow mononuclear stem cells
severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale
Time frame: 3-6 months
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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