Stem Cell Ophthalmology Treatment Study II

NCT03011541 | Recruiting

• 1 other identifier: SCOTS2
• Study Type: interventional
• Target: 500
• Locations: 3 countries
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from pre-procedure to 12 months

Secondary Outcomes (2)

• Visual Fields

  Change from pre-procedure to 12 months

• Optical Coherence Tomography (OCT)

  Change from pre-procedure to 12 months

Study Arms (1)

Arm 1

OTHER

BMSC provided retrobulbar, subtenon and intravenous for one or both eyes

Procedure: Arm 1

Interventions

Arm 1 PROCEDURE

Procedure/ Surgery: RB (Retrobulbar) Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: ST (Subtenon) Subtenon injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: IV (Intravenous) Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)

Also known as: Retrobulbar( RB), Subtenon (ST), Intravenous (IV)

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MD Stem Cells: lead

Study Sites (4)

MD Stem Cells

Westport, Connecticut, 06880, United States

RECRUITING

MD Stem Cells

Coral Springs, Florida, 33065, United States

RECRUITING

MD Stem Cells Kobinia Med

Vienna, Austria, 1010, Austria

RECRUITING

The Saudi-German Hospital

Dubai, United Arab Emirates, 337-1500, United Arab Emirates

RECRUITING

Related Publications (11)

• 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.

  PMID: 26199618 BACKGROUND

• 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.

  PMID: 26604914 BACKGROUND

• 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.

  PMID: 27857759 BACKGROUND

• 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.

  PMID: 27904503 BACKGROUND

• 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.

  PMID: 29270420 BACKGROUND

• 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.

  PMID: 30050918 BACKGROUND

• 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.

  PMID: 31119146 BACKGROUND

• 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.

  PMID: 31620478 BACKGROUND

• 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.

  PMID: 32039263 BACKGROUND

• 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.

  PMID: 32231088 BACKGROUND

• 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.

  PMID: 33546345 BACKGROUND

MeSH Terms

Conditions

Retinal Diseases; Macular Degeneration; Retinitis Pigmentosa; Stargardt Disease; Optic Nerve Diseases; Optic Atrophy; Glaucoma; Optic Atrophy, Hereditary, Leber; Blindness; Vitamin A Deficiency; Vision, Low; Eye Diseases; Geographic Atrophy; Wet Macular Degeneration; Retinal Dystrophies; Doyne honeycomb retinal dystrophy; Cone Dystrophy; Cone-Rod Dystrophies; Optic Neuropathy, Ischemic; Optic Nerve Injuries; Neuromyelitis Optica; Usher Syndromes; Optic Atrophy, Autosomal Dominant; Vision Disorders

Condition Hierarchy (Ancestors)

Retinal Degeneration; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cranial Nerve Diseases; Nervous System Diseases; Ocular Hypertension; Optic Atrophies, Hereditary; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vascular Diseases; Cardiovascular Diseases; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Optic Neuritis; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Deaf-Blind Disorders; Deafness; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Loss, Sensorineural; Abnormalities, Multiple; Congenital Abnormalities

Study Officials

• Steven Levy, MD

  MD Stem Cells

  STUDY CHAIR

• Jeffrey Weiss, MD

  Coral Springs Florida, Vienna Austria, Dubai UAE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Levy, MD

CONTACT

203-423-9494; stevenlevy@mdstemcells.com

Steven Levy, MD

CONTACT

203-423-9494

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm- Arm 1. Comparator is natural history of the disease.

Study Record Dates

• First Submitted: January 1, 2017
• First Posted: January 5, 2017
• Study Start: January 1, 2016
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (2); AE (1)