Recruiting

SCOTS2Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II

What is being tested

Arm 1

Procedure

Who is being recruted

Congenital Abnormalities+63

+ Abnormalities, Multiple

+ Cone-Rod Dystrophies

Over 18 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: January 2016

See protocol details

Summary

Principal SponsorMD Stem Cells

Study ContactSteven Levy, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleBone Marrow Derived Stem Cell Ophthalmology Treatment Study II

NCT03011541

Principal SponsorMD Stem Cells

Study ContactSteven Levy, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesAbnormalities, MultipleCone-Rod DystrophiesCone DystrophyStargardt DiseaseAutoimmune DiseasesAvitaminosisBlindnessCardiovascular DiseasesCranial Nerve DiseasesDeafnessDeficiency DiseasesDemyelinating DiseasesEar DiseasesEye DiseasesGlaucomaCraniocerebral TraumaHearing DisordersHearing Loss, SensorineuralImmune System DiseasesMacular DegenerationMetabolic DiseasesMyelitis, TransverseCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeurologic ManifestationsNeuromyelitis OpticaNutrition DisordersNutritional and Metabolic DiseasesOcular HypertensionOptic AtrophyOptic Nerve DiseasesOptic NeuritisOtorhinolaryngologic DiseasesRetinal DegenerationRetinal DiseasesRetinitis PigmentosaSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesVision DisordersVitamin A DeficiencyWounds and InjuriesVision, LowOptic Atrophies, HereditaryEye Diseases, HereditaryOptic Neuropathy, IschemicNeurodegenerative DiseasesTrauma, Nervous SystemCranial Nerve InjuriesOptic Nerve InjuriesHeredodegenerative Disorders, Nervous SystemAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNSMitochondrial DiseasesOptic Atrophy, Autosomal DominantOptic Atrophy, Hereditary, LeberGenetic Diseases, InbornHearing LossMalnutritionUsher SyndromesDeaf-Blind DisordersGeographic AtrophyWet Macular DegenerationRetinal Dystrophies

Criteria

8 inclusion criteria required to participate

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 ).

Show More Criteria

4 exclusion criteria prevent from participating

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

MD Stem Cells

Westport, United StatesOpen MD Stem Cells in Google Maps

Recruiting

MD Stem Cells

Coral Springs, United States

Recruiting

MD Stem Cells Kobinia Med

Vienna, Austria

Recruiting

The Saudi-German Hospital

Dubai, United Arab Emirates

Recruiting

4 Study Centers