Clinical trial NCT01920867: Stem Cell Ophthalmology Treatment Study
Official title: Bone Marrow Derived Stem Cell Ophthalmology Treatment Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Disease
Macular Degeneration
Hereditary Retinal Dystrophy
Optic Nerve Disease
Glaucoma
Keywords: Stem Cells
Bone Marrow Derived Stem Cells
BMSC
BMC (Bone Marrow Cell)
Mesenchymal Stem Cells
MSC
Eye Disease
Eye Stem Cells
Ophthalmology
Ophthalmic Disease
Retina
Retinal Disease
Macular Degeneration
Age Related Macular Degeneration
Myopic Macular Degeneration
Geographic Atrophy
Dry Macular Degeneration
Wet Macular Degeneration
Retinal Atrophy
Retinal Dystrophy
Hereditary Retinal Dystrophy
Retinitis Pigmentosa
Stargardt Disease
Cone Dystrophy
Cone Rod Dystrophy
Maculopathy
Optic Nerve Disease
Optic Nerve Atrophy
Optic Atrophy
Ischemic Optic Neuropathy
Optic Nerve Damage
Optic Nerve Compression
Compressive Optic Neuropathy
Devics Syndrome
Lead sponsor: MD Stem Cells
Sponsor class: INDUSTRY
First posted: 2013-08-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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/

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.

Eligibility 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.

Primary outcomes:
measure: Visual acuity
timeFrame: 1 day to 12 months
Secondary outcomes:
measure: Visual fields
timeFrame: 1 day to 12 months
Other outcomes:
Locations:
city: Westport
country: United States
facility: MD Stem Cells
state: Connecticut
Study officials:
affiliation: MD Stem Cells
name: Steven Levy, MD
role: STUDY_DIRECTOR
affiliation: MD Stem Cells
name: Jeffrey Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.