Age Related Macular Degeneration Clinical Trial
Official title:
Intravitreal Injection of Human Bone Marrow Derived Mesenchymal Stem Cell in Patients With Dry Age-related Macular Degeneration(AMD)
The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral intravitreally transplantation of adult bone marrow stem cells in subjects with geographic atrophy secondary to age-related macular degeneration.
This study is an open-label investigation of the safety and preliminary efficacy of
unilateral intravitreal injection of autologous bone marrow stem cells in subjects with
Geographic Atrophy secondary to Age-Related Macular Degeneration (AMD). Subjects will be
enrolled based on specific inclusion/exclusion criteria and evaluated at regular post
transplant intervals.
Human central nervous system -stem cells will be transplanted by a vitreoretinal surgeon.
The transplantation will be conducted in the eye with the inferior best-corrected visual
acuity (BCVA) (i.e., the Study Eye). Only the Study Eye will undergo transplantation. The
adult bone marrow stem cells will be administered into the vitreous cavity through a
standard surgical approach.
Moxifloxacin 300 mg(once per day ) will be administered orally to all subjects for a period
of five days ( 2 days pre and post operatively) .
Subjects will be monitored frequently for a total of one year after adult bone marrow stem
cells cell injection .
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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