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

Completed · Phase 1/Phase 2

Conditions studied: Age Related Macular Degeneration, Macular Degeneration, AMD

In brief

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.

Key facts

Study ID

NCT01632527

Run by

StemCells, Inc.

People needed

15

Starts

2012-06-01

Expected to finish

2015-06-01

Last updated by the study team

2015-09-14

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Retina-Vitreaous Associates Medical Group — Los Angeles, California, United States
• Byers Eye Institute at Stanford, Stanford Hospital and Clinics — Palo Alto, California, United States
• New York Eye and Ear Infirmary — New York, New York, United States
• Retina Research Institute of Texas — Abilene, Texas, United States
• Retina Foundation of the Southwest — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.