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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: StemCells, Inc.

Criteria

Inclusion Criteria:

• 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:

• 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)