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| ID | Type | Description | Link |
|---|---|---|---|
| 4619792013 | Other Grant/Funding Number | Al-Azhar university |
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| Name | Class |
|---|---|
| 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 |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous bone marrow stem cells | Experimental | use of autologous bone marrow derived stem cells as intravitreal injection in AMD patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous bone marrow derived stem cells | Drug | intravitreal injection of autologous bone marrow stem cells in 0.1 ml volume |
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| Measure | Description | Time Frame |
|---|---|---|
| number of subjects with adverse events | Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of visual function changes from the base line | 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdelhakim mohamed safwat, M.D. | Contact | +201005151919 | abdelhakimsafwat@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Azhar university medical school (Benin-cairo) ophthalmology department | Recruiting | Cairo | Nasr City | Egypt |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| UNKNOWN |
| Abou el kheir, Wael, M.D. M.Sc. | UNKNOWN |
| Gabr, Hala , M.D. M.Sc. | UNKNOWN |
| Bakry, Sayed , phD. M.Sc. | UNKNOWN |
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