Clinical Trial: Stem Cell Ophthalmology Treatment Study II

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II

Brief 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.

Detailed Summary: 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.
Sponsor: MD Stem Cells

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: MD Stem Cells

Dates:
Date Received: January 1, 2017
Date Started: January 2016
Date Completion: January 2021
Last Updated: January 3, 2017
Last Verified: January 2017