Retinal DiseaseSCOTS2NCT03011541
Stem Cell Ophthalmology Treatment Study II
A study testing Arm 1 in people with Retinal Disease and Age-Related Macular Degeneration, run by MD Stem Cells at 4 sites in 3 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Disease, Age-Related Macular Degeneration, Retinitis Pigmentosa
- What is being tested?
- Arm 1
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jan 2016to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Steven Levy, MD contact
4 sites in 3 countries
United States2 sites, 2 recruiting
- Recruiting
MD Stem Cells
Coral Springs, Florida, 33065
Steven Levy, MD, 203-423-9494
- Recruiting
MD Stem Cells
Westport, Connecticut, 06880
Steven Levy, MD, 203-423-9494, stevenlevy@mdstemcells.com
Steven Levy, MD, 203-423-9494
Austria1 site, 1 recruiting
- Recruiting
MD Stem Cells Kobinia Med
Vienna, Austria, 1010
Steven Levy, MD, 001-203-423-9494, stevenlevy@mdstemcells.com
Gloria,Office Manager, 001-203-423-9494, stevenlevy@mdstemcells.com
United Arab Emirates1 site, 1 recruiting
- Recruiting
The Saudi-German Hospital
Dubai, United Arab Emirates, 337-1500
Steven Levy, MD, (001) 203-423-9494, stevenlevy@mdstemcells.com
Jeffrey Weiss, MD
About this study
Official title: Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II
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.
- Conditions
- Retinal Disease, Age-Related Macular Degeneration, Retinitis Pigmentosa, Stargardt Disease, Optic Neuropathy, Nonarteritic Ischemic Optic Neuropathy
- Being tested
- Arm 1
- 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
- Medical subject headings
- Retinal Diseases, Macular Degeneration, Retinitis Pigmentosa, Stargardt Disease, Optic Nerve Diseases, Optic Atrophy, Glaucoma, Optic Atrophy, Hereditary, Leber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1Procedure or surgery
Also called Retrobulbar( RB), Subtenon (ST), Intravenous (IV)
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | BMSC provided retrobulbar, subtenon and intravenous for one or both eyes Receives: Procedure: Arm 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from pre-procedure to 12 months
Secondary outcomes (2)
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.
Measured: Change from pre-procedure to 12 months
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.
Measured: Change from pre-procedure to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2016
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm- Arm 1. Comparator is natural history of the disease.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MD Stem Cells
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Levy, MD, Study chair, MD Stem CellsJeffrey Weiss, MD, Principal investigator, Coral Springs Florida, Vienna Austria, Dubai UAE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011541
- Sponsor's protocol ID
- SCOTS2
- Acronym
- SCOTS2
- Status last verified
- Jun 2026
- First submitted
- 1 Jan 2017
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data (IPD)
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 26199618Weiss 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 26604914Weiss 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 27857759Weiss 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 27904503Weiss 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 29270420Weiss 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 30050918Weiss 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 31119146Weiss 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 31620478Weiss 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 32039263Weiss 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 32231088Weiss 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II
- ClinicalTrials.gov ID
- NCT03011541
- Acronym / sponsor ID
- SCOTS2 / SCOTS2
- Conditions
- Retinal Disease, Age-Related Macular Degeneration, Retinitis Pigmentosa, Stargardt Disease, Optic Neuropathy, Nonarteritic Ischemic Optic Neuropathy
- Keywords
- Stem Cells, Bone Marrow Derived Stem Cells, BMSC, Mesenchymal Stem Cells, MSC, Eye Disease, Ophthalmology, Ophthalmic Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- MD Stem CellsIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm- Arm 1. Comparator is natural history of the disease.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Arm 1BMSC provided retrobulbar, subtenon and intravenous for one or both eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1Also: Retrobulbar( RB), Subtenon (ST), Intravenous (IV)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) | Procedure or surgery | Arm 1 |
Primary outcome
Visual Acuity
Time frame: Change from pre-procedure to 12 months
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.
2 secondary outcomes
Visual Fields
Time frame: Change from pre-procedure to 12 months
Optical Coherence Tomography (OCT)
Time frame: Change from pre-procedure to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 26199618Weiss 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.
- Results publication: PubMed 26604914Weiss 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.
- Results publication: PubMed 27857759Weiss 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.
- Results publication: PubMed 27904503Weiss 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.
- Results publication: PubMed 29270420Weiss 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.
- Results publication: PubMed 30050918Weiss 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.
- Results publication: PubMed 31119146Weiss 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.
- Results publication: PubMed 31620478Weiss 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.
- Results publication: PubMed 32039263Weiss 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.
- Results publication: PubMed 32231088Weiss 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.
- Results publication: PubMed 33546345Weiss 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.
- Individual participant dataSharing planned: No. The investigators do not plan to share individual participant data (IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Levy, MD contact
Steven Levy, MD study chair
MD Stem Cells
Jeffrey Weiss, MD principal investigator
Coral Springs Florida, Vienna Austria, Dubai UAE
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1 in people with Retinal Disease and Age-Related Macular Degeneration, run by MD Stem Cells at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Austria, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Levy, MD (203-423-9494, stevenlevy@mdstemcells.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: Change from pre-procedure to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03011541, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.