Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a preliminary report.
Jeffrey N Weiss, Steven Levy, Alexis Malkin
https://pubmed.ncbi.nlm.nih.gov/26199618Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03011541
Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II for Retinal and Optic Nerve Damage
Led by MD Stem Cells · Updated on 2025-03-20
500
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of autologous bone marrow derived stem cells (BMSC) to treat vision loss caused by retinal or optic nerve damage that is generally considered irreversible. The study focuses on conditions such as macular degeneration, hereditary retinal dystrophies including retinitis pigmentosa and Stargardt disease, ischemic retinopathies, optic nerve damage from glaucoma, ischemic optic neuropathy, and optic atrophy. The goal is to assess whether these stem cells can improve vision in affected eyes. Participants will receive a combination of injections of their own bone marrow derived stem cells through several methods, including retrobulbar, subtenon, intravenous, intravitreal, intraocular, or subretinal injections. The treatment is administered using standard medical and surgical techniques. The study has one treatment group receiving these injections in one or both eyes. After treatment, participants will be followed for 12 months, during which they will have regular comprehensive eye exams with imaging and diagnostic tests. Throughout the study, participants will undergo assessments such as visual acuity tests, visual field measurements, and Optical Coherence Tomography (OCT) scans to monitor changes from before the procedure to 12 months after. Researchers will track vision improvements and any changes in eye structure or function. Safety and health will be closely monitored, and participants must attend follow-up eye exams as scheduled. The total participation time is about one year post-treatment.
CONDITIONS
Brief Title
Stem Cell Ophthalmology Treatment Study II
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Have documented retinal or optic nerve damage unlikely to improve or progressive damage with 20/30 or worse best corrected central visual acuity or abnormal visual field in one or both eyes
- Be at least 3 months post-surgical treatment for eye disease and stable
- If on medical therapy for retinal or optic nerve disease, be stable and unlikely to improve
- Have potential for improvement with stem cell treatment and minimal risk from the procedure
- Be 18 years of age or older
- Be medically stable and cleared by a primary care physician for the procedure
You will not qualify if you...
- Unable to undergo adequate ophthalmologic examination to document eye pathology
- Unable or unwilling to attend follow-up eye exams as outlined in the protocol
- Unable to provide informed consent
- At significant risk to general health or eye function if undergoing the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Single treatment procedure with immediate post-procedure period
Participants receive injections of autologous bone marrow derived stem cells via retrobulbar, subtenon, and intravenous routes for retinal or optic nerve damage.
1 treatment visit (in-person)
Follow-up
Duration - 12 months
Participants are followed for 12 months with comprehensive eye examinations including imaging and diagnostic ophthalmic testing to monitor changes in vision and eye health.
Multiple follow-up visits over 12 months for eye exams and imaging
Trial Site Locations
Total: 4 locations
1
MD Stem Cells
Westport, Connecticut, United States, 06880
Actively Recruiting
2
MD Stem Cells
Coral Springs, Florida, United States, 33065
Actively Recruiting
3
MD Stem Cells Kobinia Med
Vienna, Austria, Austria, 1010
Actively Recruiting
4
The Saudi-German Hospital
Dubai, United Arab Emirates, United Arab Emirates, 337-1500
Actively Recruiting
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Research Team
S
Steven Levy, MD
S
Steven Levy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a case report of improvement in relapsing auto-immune optic neuropathy.
Jeffrey N Weiss, Steven Levy, Susan C Benes
https://pubmed.ncbi.nlm.nih.gov/26604914Stem Cell Ophthalmology Treatment Study (SCOTS): improvement in serpiginous choroidopathy following autologous bone marrow derived stem cell treatment.
Jeffrey N Weiss, Susan C Benes, Steven Levy
https://pubmed.ncbi.nlm.nih.gov/27857759Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow-derived stem cells in the treatment of Leber's hereditary optic neuropathy.
Jeffrey N Weiss, Steven Levy, Susan C Benes
https://pubmed.ncbi.nlm.nih.gov/27904503Stem Cell Ophthalmology Treatment Study: bone marrow derived stem cells in the treatment of non-arteritic ischemic optic neuropathy (NAION).
Jeffrey N Weiss, Steven Levy, Susan C Benes
https://pubmed.ncbi.nlm.nih.gov/29270420Stem Cell Ophthalmology Treatment Study: bone marrow derived stem cells in the treatment of Retinitis Pigmentosa.
Jeffrey N Weiss, Steven Levy
https://pubmed.ncbi.nlm.nih.gov/30050918Dynamic light scattering spectroscopy of the retina-a non-invasive quantitative technique to objectively document visual improvement following ocular stem cell treatment.
Jeffrey N Weiss, Steven Levy
https://pubmed.ncbi.nlm.nih.gov/31119146Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow derived stem cells in the treatment of Usher syndrome.
Jeffrey N Weiss, Steven Levy
https://pubmed.ncbi.nlm.nih.gov/31620478Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow derived stem cells in the treatment of Dominant Optic Atrophy.
Jeffrey N Weiss, Steven Levy
https://pubmed.ncbi.nlm.nih.gov/32039263Stem Cell Ophthalmology Treatment Study (SCOTS): Bone Marrow-Derived Stem Cells in the Treatment of Age-Related Macular Degeneration.
Jeffrey N Weiss, Steven Levy
https://pubmed.ncbi.nlm.nih.gov/32231088