Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Age-Related Macular Degeneration (AMD)

Trial ID or NCT#

NCT01632527

Status

recruiting iconRECRUITING

Purpose

The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic atrophy secondary to age-related macular degeneration.

Official Title

Phase I/II Study of the Safety and Preliminary Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration

Eligibility Criteria

Ages Eligible for Study: Older than 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Diagnosis of age-related macular degeneration with geographic atrophy (GA) - Only patients with a specific degree and extent of GA will be eligible - Subjects with best-corrected visual acuity (BCVA) of less than or equal to 20/400 in the Study Eye will be enrolled in Cohort I. Subjects with BCVA of 20/320 to 20/100 in the Study Eye will be enrolled in Cohort II - No prior or current choroidal neovascularization in either eye - Must have adequate care-giver support and access to medical care in the local community - Able to provide written informed consent prior to any study related procedures - Agree to comply in good faith with all conditions of the study and to attend all required study visits
Exclusion Criteria:
  1. - Prior vitreal or retinal surgery - Glaucoma - Atrophic macular disease of any other cause - Diabetic retinopathy or diabetic macular edema in either eye - Previous organ, tissue or bone marrow transplantation - Previous participation in a gene transfer or a cell transplant trial - Autoimmune disease - Allergy to tacrolimus, mycophenolate mofetil (MMF), scopolamine, Cyclogyl, Moxifloxacin, or Gatifloxacin - Current or prior malignancy (or is on chemotherapy)
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Investigator(s)

Theodore Leng, MD, FACS
Theodore Leng, MD, FACS
Ophthalmologist
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)

Contact us to find out if this trial is right for you.

Contact

Lorella Cabael
650-498-4486

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View on ClinicalTrials.gov