Clinical trial NCT03011541: Stem Cell Ophthalmology Treatment Study II
Official title: Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinal Disease
Age-Related Macular Degeneration
Retinitis Pigmentosa
Stargardt Disease
Optic Neuropathy
Nonarteritic Ischemic Optic Neuropathy
Optic Atrophy
Optic Nerve Disease
Glaucoma
Leber Hereditary Optic Neuropathy
Blindness
Vision Loss Night
Vision Loss Partial
Vision, Low
Retinopathy
Maculopathy
Macular Degeneration
Retina Atrophy
Keywords: Stem Cells
Bone Marrow Derived Stem Cells
BMSC
Mesenchymal Stem Cells
MSC
Eye Disease
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
Malattia Leventinese
Retinitis Pigmentosa
Stargardt Disease
Cone Dystrophy
Rod-Cone Dystrophy
Cone-Rod Dystrophy
Maculopathy
Optic Nerve Disease
Optic Atrophy
Optic Neuropathy
Ischemic Optic Neuropathy
Optic Nerve Damage
Optic Nerve Compression
Compressive Optic Neuropathy
Devics Syndrome
Ushers Syndrome
Neuromyelitis Optica
Dominant Optic Atrophy
Kjers Optic Atrophy
Leber Hereditary Optic Neuropathy
Blindness
Vision Loss
Retina Atrophy
Lead sponsor: MD Stem Cells
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Arm- Arm 1. Comparator is natural history of the disease.
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.

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 20/30 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: Change from pre-procedure to 12 months
Secondary outcomes:
measure: Visual Fields
timeFrame: Change from pre-procedure to 12 months
measure: Optical Coherence Tomography (OCT)
timeFrame: Change from pre-procedure to 12 months
Other outcomes:
Locations:
city: Westport
country: United States
facility: MD Stem Cells
state: Connecticut
city: Coral Springs
country: United States
facility: MD Stem Cells
state: Florida
city: Vienna
country: Austria
facility: MD Stem Cells Kobinia Med
city: Dubai
country: United Arab Emirates
facility: The Saudi-German Hospital
Study officials:
affiliation: MD Stem Cells
name: Steven Levy, MD
role: STUDY_CHAIR
affiliation: Coral Springs Florida, Vienna Austria, Dubai UAE
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: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.