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

NCT ID: NCT02467634

Last Updated: 2016-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HuCNS-SC

HuCNS-SC sub-retinal transplantation

Group Type EXPERIMENTAL

HuCNS-SC sub-retinal transplantation

Intervention Type BIOLOGICAL

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

Interventions

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HuCNS-SC sub-retinal transplantation

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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StemCells, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel Naor, MD

Role: STUDY_CHAIR

StemCells, Inc.

Locations

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Retina Associates Southwest, PC

Tucson, Arizona, United States

Site Status

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

Retinal Diagnostic Center

Campbell, California, United States

Site Status

Northern California Retina Vitreous Associates

Mountain View, California, United States

Site Status

Retina Research Institute of Texas

Palo Alto, California, United States

Site Status

Rush University Med Ctr.

Chicago, Illinois, United States

Site Status

William Beaumont Health System

Royal Oak, Michigan, United States

Site Status

New York Eye and Ear Infirmary

New York, New York, United States

Site Status

Retina Research Institute of Texas

Abilene, Texas, United States

Site Status

Retina Research Center

Austin, Texas, United States

Site Status

Retina Foundation of the Southwest

Dallas, Texas, United States

Site Status

University Of Utah / John A. Moran Eye Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CL-AMD-201

Identifier Type: -

Identifier Source: org_study_id

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