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RecruitingNCT03011541SCOTS2Updated Jun 29, 2026

Stem Cell Ophthalmology Treatment Study II

An interventional study of Arm 1 in Retinal Disease, Age-Related Macular Degeneration and Retinitis Pigmentosa, sponsored by MD Stem Cells. Recruiting at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by MD Stem Cells · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Other
    Arm 1

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

    Procedure: Arm 1

Interventions

  • ProcedureArm 1

    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)

05

What researchers measure

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.

    Time frame: Change from pre-procedure to 12 months

Secondary outcomes

  1. Visual Fields

    Visual fields will be evaluated with automated perimetry during post- procedure visits as needed and specifically at 6 months and 12 months. Visual fields are a key measurement in patients with peripheral vision loss.

    Time frame: Change from pre-procedure to 12 months

  2. Optical Coherence Tomography (OCT)

    OCT thickness of the retinal nerve fiber layer the optic nerve and/or macula during the post- procedure visits as needed and specifically at 6 and 12 months - if available.

    Time frame: Change from pre-procedure to 12 months

06

Study locations

4 of 4 sites recruiting
  • MD Stem Cells
    Westport, Connecticut 06880, United States
    • Steven Levy, MD · Contact · stevenlevy@mdstemcells.com · 203-423-9494
    • Steven Levy, MD · Contact · 203-423-9494
    • Steven Levy, MD · Sub investigator
    • Jeffrey Weiss, MD · Principal investigator
    Recruiting
  • MD Stem Cells
    Coral Springs, Florida 33065, United States
    • Steven Levy, MD · Contact · 203-423-9494
    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
07

References and documents

Publications

  • 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. PubMed 26199618 ↗
  • 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. PubMed 26604914 ↗
  • 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. PubMed 27857759 ↗
  • 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. PubMed 27904503 ↗
  • 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. PubMed 29270420 ↗
  • 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. PubMed 30050918 ↗
  • 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. PubMed 31119146 ↗
  • 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. PubMed 31620478 ↗
  • 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. PubMed 32039263 ↗
  • 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. PubMed 32231088 ↗
  • 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. PubMed 33546345 ↗

Individual participant data

Plan to share: No — The investigators do not plan to share individual participant data (IPD)

08

Registry details

Key details

Study ID
NCT03011541
Lead sponsor
MD Stem Cells
Responsible party
Sponsor
First posted
Jan 5, 2017
Start date
Jan 2016
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Jun 29, 2026

Study contacts

Steven Levy, MD
Contact
stevenlevy@mdstemcells.com
203-423-9494
Steven Levy, MD
Contact
203-423-9494
Steven Levy, MD
study chair · MD Stem Cells
Jeffrey Weiss, MD
principal investigator · Coral Springs Florida, Vienna Austria, Dubai UAE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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