Stem Cell Ophthalmology Treatment Study II (SCOTS2)

MD Stem Cells

Status

Enrolling

Conditions

Maculopathy

Age-Related Macular Degeneration

Stargardt Disease

Retina Atrophy

Leber Hereditary Optic Neuropathy

Vision Loss Partial

Vision Loss Night

Retinal Disease

Blindness

Retinopathy

Optic Atrophy

Macular Degeneration

Glaucoma

Optic Neuropathy

Optic Nerve Disease

Retinitis Pigmentosa

Nonarteritic Ischemic Optic Neuropathy

Vision, Low

Treatments

Procedure: Arm 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT03011541

SCOTS2

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.