Safety Study of Use of Autologous Bone Marrow Derived Stem Cell in Treatment of Age Related Macular Degeneration
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|ClinicalTrials.gov Identifier: NCT02016508|
Recruitment Status : Unknown
Verified December 2013 by abdelhakim mohamed safwat, Al-Azhar University.
Recruitment status was: Recruiting
First Posted : December 20, 2013
Last Update Posted : December 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Drug: autologous bone marrow derived stem cells||Phase 1 Phase 2|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravitreal Injection of Human Bone Marrow Derived Mesenchymal Stem Cell in Patients With Dry Age-related Macular Degeneration(AMD)|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||June 2015|
Experimental: autologous bone marrow stem cells
use of autologous bone marrow derived stem cells as intravitreal injection in AMD patients
Drug: autologous bone marrow derived stem cells
intravitreal injection of autologous bone marrow stem cells in 0.1 ml volume
- number of subjects with adverse events [ Time Frame: 6 months ]Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period
- Assessment of visual function changes from the base line [ Time Frame: 6 months ]assessment will include Change in the mean of BCVA, Optical Coherence Tomography imaging, fluorescein angiography, slitlamp examination with fundus photography, Electroretinographic evidence (mfERG) showing enhanced activity in the location
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016508
|Contact: Abdelhakim mohamed safwat, M.D.||+firstname.lastname@example.org|
|Al-Azhar university medical school (Benin-cairo) ophthalmology department||Recruiting|
|Cairo, Nasr city, Egypt|
|Principal Investigator: Abdelhakim Mohamed Safwat, Msc|