Stem Cell Ophthalmology Treatment Study II

Last updated: March 17, 2025
Sponsor: MD Stem Cells
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Aging

Eye Disease

Treatment

Arm 1

Clinical Study ID

NCT03011541
SCOTS2
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have objective, documented damage to the retina or optic nerve unlikely to improveOR

  • Have objective, documented damage to the retina or optic nerve that is progressiveAND have less than or equal to 20/30 best corrected central visual acuity in one orboth eyes AND/OR an abnormal visual field in one or both eyes.

  • Be at least 3 months post-surgical treatment intended to treat any ophthalmologicdisease and stable.

  • If under current medical therapy ( pharmacologic treatment) for a retinal or opticnerve disease be considered stable on that treatment and unlikely to have visualfunction improvement ( for example, glaucoma with intraocular pressure stable ontopical medications but visual field damage ).

  • Have the potential for improvement with BMSC treatment and be at minimal risk of anypotential harm from the procedure.

  • Be over the age of 18

  • Be medically stable and able to be medically cleared by their primary care physicianor a licensed primary care practitioner for the procedure.

  • Medical clearance means that in the estimation of the primary care practitioner, thepatient can reasonably be expected to undergo the procedure without significantmedical risk to health.

Exclusion

Exclusion Criteria:

  • Patients who are not capable of an adequate ophthalmologic examination or evaluationto document the pathology.

  • Patients who are not capable or not willing to undergo follow up eye exams with theprinciple investigator or their ophthalmologist or optometrist as outlined in theprotocol.

  • Patients who are not capable of providing informed consent.

  • Patients who may be at significant risk to general health or to the eyes and visualfunction should they undergo the procedure.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Arm 1
Phase:
Study Start date:
January 01, 2016
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • MD Stem Cells Kobinia Med

    Vienna, 1010
    Austria

    Active - Recruiting

  • Fakeeh University Hospital

    Dubai Silicon Oasis, Dubai
    United Arab Emirates

    Site Not Available

  • Fakeeh University Hospital

    Dubai Silicone Oasis, Dubai
    United Arab Emirates

    Site Not Available

  • Medcare Orthopaedics & Spine Hospital

    Dubai,
    United Arab Emirates

    Active - Recruiting

  • The Saudi-German Hospital

    Dubai, 337-1500
    United Arab Emirates

    Active - Recruiting

  • MD Stem Cells

    Westport, Connecticut 06880
    United States

    Active - Recruiting

  • MD Stem Cells

    Coral Springs, Florida 33065
    United States

    Active - Recruiting

  • The Healing Institute

    Margate, Florida 33063
    United States

    Site Not Available

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