Safety Study of Use of Autologous Bone Marrow Derived Stem Cell in Treatment of Age Related Macular Degeneration
NCT ID: NCT02016508
Last Updated: 2013-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
1 participants
INTERVENTIONAL
2013-03-31
2015-06-30
Brief Summary
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Detailed Description
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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 .
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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autologous bone marrow stem cells
use of autologous bone marrow derived stem cells as intravitreal injection in AMD patients
autologous bone marrow derived stem cells
intravitreal injection of autologous bone marrow stem cells in 0.1 ml volume
Interventions
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autologous bone marrow derived stem cells
intravitreal injection of autologous bone marrow stem cells in 0.1 ml volume
Eligibility Criteria
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Inclusion Criteria
* Only patients with a specific degree and extent of GA will be eligible
* Subjects with best-corrected visual acuity (BCVA) of less than or equal to 20/400 in the Study Eye
* No prior or current choroidal neovascularization in either eye
* Able to provide written informed consent prior to any study related procedures
* Agree to comply in good faith with all conditions of the study and to attend all required study visits
Exclusion Criteria
* Glaucoma
* Atrophic macular disease of any other cause
* Diabetic retinopathy or diabetic macular edema in either eye
* Previous organ, tissue or bone marrow transplantation
* Autoimmune disease
* Allergy to moxifloxacin
* Current or prior malignancy (or is on chemotherapy)
50 Years
ALL
No
Sponsors
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Hassan , Hosny , M.D. M.Sc
UNKNOWN
Samour , Hany M.D. M.Sc
UNKNOWN
Ismail , Mahmoud M.D. M.Sc
UNKNOWN
Higazy , Hasan M.D. M.Sc
UNKNOWN
Abou el kheir, Wael, M.D. M.Sc.
UNKNOWN
Gabr, Hala , M.D. M.Sc.
UNKNOWN
Bakry, Sayed , phD. M.Sc.
UNKNOWN
Al-Azhar University
OTHER
Responsible Party
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abdelhakim mohamed safwat
assistant lecturer ophthalmology department al-azhar university
Locations
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Al-Azhar university medical school (Benin-cairo) ophthalmology department
Cairo, Nasr City, Egypt
Countries
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Central Contacts
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Other Identifiers
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4619792013
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NCT 4619792013
Identifier Type: -
Identifier Source: org_study_id