NCT01632527

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2012

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 3, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

3 years

First QC Date

June 21, 2012

Last Update Submit

September 10, 2015

Conditions

Age Related Macular DegenerationMacular DegenerationAMD

Keywords

Age-Related Macular DegenerationDry AMD with GAGeographic Atrophy of Age-Related Macular DegenerationStem Cell TransplantationStem Cell transplantStem cells for AMDHuman neural stem cellsmultipotent stem cellsMacular DegenerationDry AMDHuman central nervous system stemcellsdry age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with adverse events

    Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period.

    One year following transplant surgery

Secondary Outcomes (1)

  • Assessment of visual function changes from baseline

    At frequent intervals for one year following transplantation

Study Arms (1)

HuCNS-SC

EXPERIMENTAL

HuCNS-SC cells

Drug: HuCNS-SC cells

Interventions

HuCNS-SC cellsDRUG

HuCNS-SC cells transplantation directly into the subretinal space of one eye (Study eye) in a single transplant procedure.

Also known as: Human Central Nervous System Stem Cells
HuCNS-SC

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Retina-Vitreaous Associates Medical Group

Los Angeles, California, 90211, United States

Location

Byers Eye Institute at Stanford, Stanford Hospital and Clinics

Palo Alto, California, 94303, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Stephen Huhn, M.D.

    StemCells, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2012

First Posted

July 3, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 14, 2015

Record last verified: 2015-09

Locations

US(5)