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This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.
Eyes with loss of vision from retinal or optic nerve conditions generally considered irreversible will be treated with a combination of injections of autologous bone marrow derived stem cells isolated from the bone marrow using standard medical and surgical practices. Retinal conditions may include degenerative, ischemic or physical damage ( examples may include macular degeneration, hereditary retinal dystrophies such as retinitis pigmentosa, stargardt, non-perfusion retinopathies, post retinal detachment. Optic Nerve conditions may include degenerative, ischemic or physical damage ( examples may include optic nerve damage from glaucoma, compression, ischemic optic neuropathy, optic atrophy ). Injections may include retrobulbar, subtenon, intravitreal, intraocular, subretinal and intravenous. Patients will be followed for 12 months with serial comprehensive eye examinations including relevant imaging and diagnostic ophthalmic testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | BMSC provided retrobulbar, subtenon and intravenous for one or both eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1 | Procedure | Procedure/ Surgery: RB (Retrobulbar) Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: ST (Subtenon) Subtenon injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: IV (Intravenous) Intravenous injection of Bone Marrow Derived Stem Cells (BMSC) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Best corrected visual acuity will be measured with Snellen Eye Chart and the ETDRS (Early Treatment Diabetic Retinopathy Study)Eye Chart when available at each post- procedure visit. Intervals at minimum will be first post- procedure day,then 3 months, 6 months and 12 months post-procedure day. Recommended visit 1 month post -procedure day. | Change from pre-procedure to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Fields | Visual fields will be evaluated with automated perimetry during post- procedure visits as needed and specifically at 6 months and 12 months. Visual fields are a key measurement in patients with peripheral vision loss. | Change from pre-procedure to 12 months |
| Optical Coherence Tomography (OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Levy, MD | Contact | 203-423-9494 | stevenlevy@mdstemcells.com | |
| Steven Levy, MD | Contact | 203-423-9494 |
| Name | Affiliation | Role |
|---|---|---|
| Steven Levy, MD | MD Stem Cells | Study Chair |
| Jeffrey Weiss, MD | Coral Springs Florida, Vienna Austria, Dubai UAE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Stem Cells | Recruiting | Westport | Connecticut | 06880 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26199618 | Result | Weiss JN, Levy S, Malkin A. Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a preliminary report. Neural Regen Res. 2015 Jun;10(6):982-8. doi: 10.4103/1673-5374.158365. | |
| 26604914 | Result | Weiss JN, Levy S, Benes SC. Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a case report of improvement in relapsing auto-immune optic neuropathy. Neural Regen Res. 2015 Sep;10(9):1507-15. doi: 10.4103/1673-5374.165525. |
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The investigators do not plan to share individual participant data (IPD)
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Single Arm- Arm 1. Comparator is natural history of the disease.
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|
|
OCT thickness of the retinal nerve fiber layer the optic nerve and/or macula during the post- procedure visits as needed and specifically at 6 and 12 months - if available. |
| Change from pre-procedure to 12 months |
| MD Stem Cells | Recruiting | Coral Springs | Florida | 33065 | United States |
|
| MD Stem Cells Kobinia Med | Recruiting | Vienna | Austria | 1010 | Austria |
|
| The Saudi-German Hospital | Recruiting | Dubai | United Arab Emirates | 337-1500 | United Arab Emirates |
|
| 27857759 | Result | Weiss JN, Benes SC, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): improvement in serpiginous choroidopathy following autologous bone marrow derived stem cell treatment. Neural Regen Res. 2016 Sep;11(9):1512-1516. doi: 10.4103/1673-5374.191229. |
| 27904503 | Result | Weiss JN, Levy S, Benes SC. Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow-derived stem cells in the treatment of Leber's hereditary optic neuropathy. Neural Regen Res. 2016 Oct;11(10):1685-1694. doi: 10.4103/1673-5374.193251. |
| 29270420 | Result | Weiss JN, Levy S, Benes SC. Stem Cell Ophthalmology Treatment Study: bone marrow derived stem cells in the treatment of non-arteritic ischemic optic neuropathy (NAION). Stem Cell Investig. 2017 Nov 23;4:94. doi: 10.21037/sci.2017.11.05. eCollection 2017. |
| 30050918 | Result | Weiss JN, Levy S. Stem Cell Ophthalmology Treatment Study: bone marrow derived stem cells in the treatment of Retinitis Pigmentosa. Stem Cell Investig. 2018 Jun 6;5:18. doi: 10.21037/sci.2018.04.02. eCollection 2018. |
| 31119146 | Result | Weiss JN, Levy S. Dynamic light scattering spectroscopy of the retina-a non-invasive quantitative technique to objectively document visual improvement following ocular stem cell treatment. Stem Cell Investig. 2019 Apr 1;6:8. doi: 10.21037/sci.2019.03.01. eCollection 2019. |
| 31620478 | Result | Weiss JN, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow derived stem cells in the treatment of Usher syndrome. Stem Cell Investig. 2019 Sep 9;6:31. doi: 10.21037/sci.2019.08.07. eCollection 2019. |
| 32039263 | Result | Weiss JN, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow derived stem cells in the treatment of Dominant Optic Atrophy. Stem Cell Investig. 2019 Dec 5;6:41. doi: 10.21037/sci.2019.11.01. eCollection 2019. |
| 32231088 | Result | Weiss JN, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): Bone Marrow-Derived Stem Cells in the Treatment of Age-Related Macular Degeneration. Medicines (Basel). 2020 Mar 28;7(4):16. doi: 10.3390/medicines7040016. |
| 33546345 | Result | Weiss JN, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): Bone Marrow-Derived Stem Cells in the Treatment of Stargardt Disease. Medicines (Basel). 2021 Feb 3;8(2):10. doi: 10.3390/medicines8020010. |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D008268 | Macular Degeneration |
| D012174 | Retinitis Pigmentosa |
| D000080362 | Stargardt Disease |
| D009901 | Optic Nerve Diseases |
| D009896 | Optic Atrophy |
| D005901 | Glaucoma |
| D029242 | Optic Atrophy, Hereditary, Leber |
| D001766 | Blindness |
| D014802 | Vitamin A Deficiency |
| D015354 | Vision, Low |
| D005128 | Eye Diseases |
| D057092 | Geographic Atrophy |
| D057135 | Wet Macular Degeneration |
| D058499 | Retinal Dystrophies |
| C535602 | Doyne honeycomb retinal dystrophy |
| D000077765 | Cone Dystrophy |
| D000071700 | Cone-Rod Dystrophies |
| D018917 | Optic Neuropathy, Ischemic |
| D020221 | Optic Nerve Injuries |
| D009471 | Neuromyelitis Optica |
| D052245 | Usher Syndromes |
| D029241 | Optic Atrophy, Autosomal Dominant |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009798 | Ocular Hypertension |
| D015418 | Optic Atrophies, Hereditary |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D028361 | Mitochondrial Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020209 | Cranial Nerve Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009902 | Optic Neuritis |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D054062 | Deaf-Blind Disorders |
| D003638 | Deafness |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006319 | Hearing Loss, Sensorineural |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
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