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NCT Number: NCT03011541

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.

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Key information

Conditions

Retinal Disease Abnormalities, Multiple Age-Related Macular Degeneration Autoimmune Diseases Autoimmune Diseases of the Nervous System Avitaminosis Blindness Cardiovascular Diseases Cone Dystrophy Cone-Rod Dystrophies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Deaf-Blind Disorders Deafness Deficiency Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Doyne honeycomb retinal dystrophy Ear Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Geographic Atrophy Glaucoma Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Heredodegenerative Disorders, Nervous System Immune System Diseases Leber Hereditary Optic Neuropathy Macular Degeneration Maculopathy Malnutrition Metabolic Diseases Mitochondrial Diseases Myelitis, Transverse Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromyelitis Optica Nonarteritic Ischemic Optic Neuropathy Nutrition Disorders Nutritional and Metabolic Diseases Ocular Hypertension Optic Atrophies, Hereditary Optic Atrophy Optic Atrophy, Autosomal Dominant Optic Atrophy, Hereditary, Leber Optic Nerve Disease Optic Nerve Diseases Optic Nerve Injuries Optic Neuritis Optic Neuropathy Optic Neuropathy, Ischemic Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Retina Atrophy Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinitis Pigmentosa Retinopathy Sensation Disorders Signs and Symptoms Stargardt Disease Trauma, Nervous System Usher Syndromes Vascular Diseases Vision Disorders Vision Loss Night Vision Loss Partial Vision, Low Vitamin A Deficiency Wet Macular Degeneration Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Stem Cells Kobinia Med, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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)

Other names: Retrobulbar( RB), Subtenon (ST), Intravenous (IV)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Visual Fields

    Time frame: Change from pre-procedure to 12 months

    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.

  2. Optical Coherence Tomography (OCT)

    Time frame: Change from pre-procedure to 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Steven Levy, MD

CONTACT

[email protected]

203-423-9494

Steven Levy, MD

CONTACT

203-423-9494

Sponsors and collaborators

Lead sponsor

MD Stem Cells

Industry

Registry information

Official study title

Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II

Acronym: SCOTS2

Important dates

Study start
2016
Primary completion
2027
Study completion
2028
First posted
Jan 5, 2017
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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