Stem Cell Ophthalmology Treatment Study (SCOTS)

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ClinicalTrials.gov Identifier: NCT01920867

Recruitment Status : Unknown

Verified October 2019 by MD Stem Cells.
Recruitment status was: Enrolling by invitation

First Posted : August 12, 2013

Last Update Posted : October 23, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

MD Stem Cells

Study Description

Brief Summary:

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/

Condition or disease	Intervention/treatment	Phase
Retinal Disease Macular Degeneration Hereditary Retinal Dystrophy Optic Nerve Disease Glaucoma	Procedure: RB (Retrobulbar) Procedure: ST (Subtenon) Procedure: IV (Intravenous) Procedure: IVIT (Intravitreal) Procedure: IO (Intraocular)	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	300 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Bone Marrow Derived Stem Cell Ophthalmology Treatment Study
Actual Study Start Date :	August 2012
Estimated Primary Completion Date :	July 2020
Estimated Study Completion Date :	July 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Age-related macular degeneration

Genetic and Rare Diseases Information Center resources: Retinitis Pigmentosa Neuromyelitis Optica Spectrum Disorder Anterior Ischemic Optic Neuropathy Cone Dystrophy Cone-rod Dystrophy Stargardt Disease Cone-rod Dystrophy 2

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: RB, ST, IV Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)	Procedure: RB (Retrobulbar) Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC) Other Name: Retrobulbar injection of stem cells Procedure: ST (Subtenon) Subtenon injection of Bone Marrow Derived Stem Cells (BMSC) Other Name: Subtenon injection of stem cells Procedure: IV (Intravenous) Intravenous injection of Bone Marrow Derived Stem Cells (BMSC) Other Name: Intravenous injection of stem cells
Active Comparator: RB, ST, IV, IVIT Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )	Procedure: RB (Retrobulbar) Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC) Other Name: Retrobulbar injection of stem cells Procedure: ST (Subtenon) Subtenon injection of Bone Marrow Derived Stem Cells (BMSC) Other Name: Subtenon injection of stem cells Procedure: IV (Intravenous) Intravenous injection of Bone Marrow Derived Stem Cells (BMSC) Other Name: Intravenous injection of stem cells Procedure: IVIT (Intravitreal) Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC) Other Name: Intravitreal injection of stem cells
Active Comparator: RB, ST, IV, IO Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy	Procedure: RB (Retrobulbar) Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC) Other Name: Retrobulbar injection of stem cells Procedure: ST (Subtenon) Subtenon injection of Bone Marrow Derived Stem Cells (BMSC) Other Name: Subtenon injection of stem cells Procedure: IV (Intravenous) Intravenous injection of Bone Marrow Derived Stem Cells (BMSC) Other Name: Intravenous injection of stem cells Procedure: IO (Intraocular) 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. Other Name: Intraocular injection of stem cells with vitrectomy

Outcome Measures

Primary Outcome Measures :

Visual acuity [ Time Frame: 1 day to 12 months ]
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.

Secondary Outcome Measures :

Visual fields [ Time Frame: 1 day to 12 months ]
Visual fields will be evaluated with automated perimetry during post- procedure visits as needed and specifically at 6 months and 12 months.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have objective, documented damage to the retina or optic nerve unlikely to improve OR
Have objective, documented damage to the retina or optic nerve that is progressive
AND have less than or equal to 20/40 best corrected central visual acuity in one or both eyes AND/OR an abnormal visual field in one or both eyes.
Be at least 3 months post-surgical treatment intended to treat any ophthalmologic disease and stable.
If under current medical therapy ( pharmacologic treatment) for a retinal or optic nerve disease be considered stable on that treatment and unlikely to have visual function improvement ( for example, glaucoma with intraocular pressure stable on topical medications but visual field damage ).
Have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
Be over the age of 18
Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.

Exclusion Criteria:

Patients who are not capable of an adequate ophthalmologic examination or evaluation to document the pathology.
Patients who are not capable or not willing to undergo follow up eye exams with the principle investigator or their ophthalmologist or optometrist as outlined in the protocol.
Patients who are not capable of providing informed consent.
Patients who may be at significant risk to general health or to the eyes and visual function should they undergo the procedure.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920867

Locations

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United States, Connecticut
MD Stem Cells
Westport, Connecticut, United States, 06880

Sponsors and Collaborators

MD Stem Cells

Investigators

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Study Director:	Steven Levy, MD	MD Stem Cells
Principal Investigator:	Jeffrey Weiss, MD	MD Stem Cells

More Information

Additional Information:

The Role of Patient Funded Clinical Research in Advancing Medical Care This link exits the ClinicalTrials.gov site

Study Data/Documents: Clinical Study Report This link exits the ClinicalTrials.gov site

http://mdstemcells.com/scots-ii/

Publications of Results:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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Responsible Party:	MD Stem Cells
ClinicalTrials.gov Identifier:	NCT01920867
Other Study ID Numbers:	ICMS-2013-0019.
First Posted:	August 12, 2013 Key Record Dates
Last Update Posted:	October 23, 2019
Last Verified:	October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by MD Stem Cells:


Stem Cells Bone Marrow Derived Stem Cells BMC (Bone Marrow Cell) Mesenchymal Stem Cells Eye Stem Cells Macular Degeneration Age Related Macular Degeneration Myopic Macular Degeneration Dry Macular Degeneration Wet Macular Degeneration Maculopathy BMSC MSC Eye Disease Ophthalmology	Ophthalmic Disease Retina Retinal Disease Geographic Atrophy Retinal Atrophy Retinal Dystrophy Hereditary Retinal Dystrophy Retinitis Pigmentosa Stargardt Disease Cone Dystrophy Cone Rod Dystrophy Optic Nerve Disease Optic Nerve Atrophy Optic Atrophy Ischemic Optic Neuropathy

Additional relevant MeSH terms:

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Nervous System Diseases Optic Nerve Diseases Macular Degeneration Retinal Diseases	Retinal Dystrophies Eye Diseases Retinal Degeneration Cranial Nerve Diseases

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