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| ID | Type | Description | Link |
|---|---|---|---|
| BMSCRetPilot | Other Identifier | Other |
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This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.
In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell treated | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD34+ bone marrow stem cells intravitreal | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of ocular adverse events | As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment. | 1 day to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The number of stem cells isolated and injected into the study eye | Will determine the yield of the bone marrow aspiration and stem cell isolation procedures. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of systemic adverse events | Any systemic adverse event attributable to the bone marrow aspiration or intravitreal injection of the stem cells. | 1 day to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanna s Park, MD PhD | University of California Davis Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27116667 | Background | Park SS. Cell Therapy Applications for Retinal Vascular Diseases: Diabetic Retinopathy and Retinal Vein Occlusion. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(5):ORSFj1-ORSFj10. doi: 10.1167/iovs.15-17594. | |
| 25491299 | Result | Park SS, Bauer G, Abedi M, Pontow S, Panorgias A, Jonnal R, Zawadzki RJ, Werner JS, Nolta J. Intravitreal autologous bone marrow CD34+ cell therapy for ischemic and degenerative retinal disorders: preliminary phase 1 clinical trial findings. Invest Ophthalmol Vis Sci. 2014 Dec 9;56(1):81-9. doi: 10.1167/iovs.14-15415. |
| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
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Once study is completed, the study findings will be published in peer reviewed publication for public access.
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D012174 | Retinitis Pigmentosa |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D015785 | Eye Diseases, Hereditary |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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