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The purpose of this study is to evaluate the behavior of intravitreal injection of of autologous bone marrow stem cells in patients with age related macular degeneration.
A prospective phase I/II, nonrandomized open-label study of agen related macular degeneration and Stargartd 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 bone marrow stem cells: 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 Bone Marrow Stem Cells: 1) improvement in ERG response; 2) increase in visual field: 3) increase in CSMT > 50um and not related to macular edemar or choroidal neovascularization; 4) increase > 5 letters on BCVA
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stem cell group | Experimental | intravitreal injection of autologous bone marrow stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravitreal injection of autologous bone marrow stem cells | Other | intravitreal injection of autologous bone marrow stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| ETDRS Visual acuity change | Primary safety outcome included visual acuity loss of 15 or more ETDRS letters after treatment | Day 1 to Day 365 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rubens C Siqueira, MD,PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rubens Siqueira Research Center | São José do Rio Preto | São Paulo | 15010-100 | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 28, 2021 | |
| Reset | Oct 18, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 28, 2021 | Oct 18, 2021 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D064987 | Cell- and Tissue-Based Therapy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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intravitreal injection of autologous bone marrow stem cells
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