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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. http://mdstemcells.com/scots-ii/
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 |
|---|---|---|---|
| RB, ST, IV | Active Comparator | Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV) |
|
| RB, ST, IV, IVIT | Active Comparator | Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT ) |
|
| RB, ST, IV, IO | Active Comparator | Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RB (Retrobulbar) | Procedure | Retrobulbar 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. | 1 day 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. | 1 day to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Levy, MD | MD Stem Cells | Study Director |
| Jeffrey Weiss, MD | MD Stem Cells | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Stem Cells | 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. |
| Label | URL |
|---|---|
| The Role of Patient Funded Clinical Research in Advancing Medical Care | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 18, 2020 | |
| Reset | Jul 10, 2020 | |
| Release | Feb 22, 2021 | |
| Reset | Mar 17, 2021 | |
| Release | Mar 13, 2023 | |
| Reset | Dec 21, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2020 | Jul 10, 2020 | |||
| Feb 22, 2021 |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D008268 | Macular Degeneration |
| D009901 | Optic Nerve Diseases |
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
| D057092 | Geographic Atrophy |
| D057135 | Wet Macular Degeneration |
| D058499 | Retinal Dystrophies |
| D012174 | Retinitis Pigmentosa |
| D000080362 | Stargardt Disease |
| D000077765 | Cone Dystrophy |
| D000071700 | Cone-Rod Dystrophies |
| D009896 | Optic Atrophy |
| D018917 | Optic Neuropathy, Ischemic |
| D020221 | Optic Nerve Injuries |
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D018538 | Jupiter |
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| ST (Subtenon) | Procedure | Subtenon injection of Bone Marrow Derived Stem Cells (BMSC) |
|
|
| IV (Intravenous) | Procedure | Intravenous injection of Bone Marrow Derived Stem Cells (BMSC) |
|
|
| IVIT (Intravitreal) | Procedure | Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC) |
|
|
| IO (Intraocular) | Procedure | Intraocular injection of Bone Marrow Derived Stem Cells (BMSC) with vitrectomy prior to intraocular injection. For example, may include larger amount of stem cells in the intravitreal cavity, intraneuronal injections or subretinal injections of stem cells. |
|
|
| 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. |
| 32568958 | Derived | Kasetty MA, Hedges TR 3rd, Witkin AJ. BILATERAL EPIRETINAL MEMBRANE FORMATION AFTER INTRAVITREAL INJECTIONS OF AUTOLOGOUS MESENCHYMAL STEM CELLS. Retin Cases Brief Rep. 2022 Sep 1;16(5):561-564. doi: 10.1097/ICB.0000000000001032. |
| 27904503 | Derived | 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. |
| Mar 17, 2021 |
| Mar 13, 2023 | Dec 21, 2023 |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D016083 | Planets |
| D016082 | Solar System |
| D055587 | Astronomical Objects |
| D055580 | Astronomical Phenomena |
| D055585 | Physical Phenomena |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |