Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2012-08-31
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RB, ST, IV
Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)
RB (Retrobulbar)
Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
ST (Subtenon)
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
IV (Intravenous)
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
RB, ST, IV, IVIT
Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )
RB (Retrobulbar)
Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
ST (Subtenon)
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
IV (Intravenous)
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
IVIT (Intravitreal)
Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)
RB, ST, IV, IO
Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy
RB (Retrobulbar)
Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
ST (Subtenon)
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
IV (Intravenous)
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
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.
Interventions
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RB (Retrobulbar)
Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
ST (Subtenon)
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
IV (Intravenous)
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
IVIT (Intravitreal)
Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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MD Stem Cells
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Levy, MD
Role: STUDY_DIRECTOR
MD Stem Cells
Jeffrey Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
MD Stem Cells
Locations
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MD Stem Cells
Westport, Connecticut, United States
Countries
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References
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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.
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.
Other Identifiers
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ICMS-2013-0019.
Identifier Type: -
Identifier Source: org_study_id
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