Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD

Overview

A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.

Full Title of Study: “A Phase II Proof-of-Concept Study of the Safety and Efficacy of HUCNS-SC Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

Detailed Description

A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.

Interventions

  • Biological: HuCNS-SC sub-retinal transplantation
    • HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD

Arms, Groups and Cohorts

  • Experimental: HuCNS-SC
    • HuCNS-SC sub-retinal transplantation

Clinical Trial Outcome Measures

Primary Measures

  • GA area based on fundus autofluorescence
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence.
  • BCVA of 20/320 or better in each eye at screening assessment

Exclusion Criteria

  • Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center.
  • Retinal or macular disease of any other cause in either eye.
  • Diagnosis of glaucoma in either eye.
  • Uncontrolled intraocular pressure in either eye
  • Compromised renal function defined as eGFR <60mL/min and urine protein-to-creatinine ration >0.3 is spot urine collection.
  • History of or active autoimmune disease.
  • Previous organ, tissue or bone marrow transplantation.
  • Seropositive for HIV, hepatitis B or C, or CMV IgM

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • StemCells, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joel Naor, MD, Study Chair, StemCells, Inc.

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