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This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of non-arteritic ischemic optic neuropathy
This patient funded trial aims to study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of non-arteritic ischemic optic neuropathy. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group (AlloRx) | Experimental | intravenous and sub-tenon delivery (total dose of 100 million cells) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlloRx | Biological | cultured allogeneic adult umbilical cord derived mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chadwick Prodromos, MD | The Foundation for Orthopaedics and Regenerative Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Surgical Associates Center | Recruiting | St John's | Antigua and Barbuda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33315474 | Background | Sung Y, Lee SM, Park M, Choi HJ, Kang S, Choi BI, Lew H. Treatment of traumatic optic neuropathy using human placenta-derived mesenchymal stem cells in Asian patients. Regen Med. 2020 Oct;15(10):2163-2179. doi: 10.2217/rme-2020-0044. Epub 2020 Dec 14. | |
| 32679004 | Background | Zhao T, Liang Q, Meng X, Duan P, Wang F, Li S, Liu Y, Yin ZQ. Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells Maintains and Partially Improves Visual Function in Patients with Advanced Retinitis Pigmentosa. Stem Cells Dev. 2020 Aug;29(16):1029-1037. doi: 10.1089/scd.2020.0037. Epub 2020 Jul 15. |
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| Center for Investigation in Tissue Engineering and Cellular Therapy | Recruiting | Buenos Aires | Argentina |
|
| 31931872 | Background | Ozmert E, Arslan U. Management of retinitis pigmentosa by Wharton's jelly derived mesenchymal stem cells: preliminary clinical results. Stem Cell Res Ther. 2020 Jan 13;11(1):25. doi: 10.1186/s13287-020-1549-6. |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012174 | Retinitis Pigmentosa |
| D003930 | Diabetic Retinopathy |
| D008268 | Macular Degeneration |
| D020221 | Optic Nerve Injuries |
| D009896 | Optic Atrophy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009901 | Optic Nerve Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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