NCT01674829

Brief Summary

To evaluate the safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry AMD To evaluate the safety of the surgical procedures when used to implant MA09-hRPE cells To assess the number of hRPE cells to be transplanted in future studies To evaluate on an exploratory basis potential efficacy endpoints to be used in future studies of MA09-hRPE cellular therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

August 22, 2012

Last Update Submit

April 5, 2024

Conditions

Dry Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Safety of hESC derived RPE cells

    The transplantation of hESC-derived RPE cells MA09-hRPE will be considered safe in the absence of: 1. Any grade 2 (NCI grading system) or greater adverse event related to the cell product 2. Any evidence that the cells are contaminated with an infectious agent 3. Any evidence that the cells show tumorigenic potential

    12 months

Secondary Outcomes (1)

  • exploratory evaluations for potential efficacy endpoints

    12months

Study Arms (4)

Cohort 1

EXPERIMENTAL

Biological: MA09-hRPE Cellular therapy Cohort 1 Dose 1

Biological: MA09-hRPE

Cohort 2

EXPERIMENTAL

Biological: MA09-hRPE Cellular therapy Cohort 2 Dose 2

Biological: MA09-hRPE

Cohort 3

EXPERIMENTAL

Biological: MA09-hRPE Cellular therapy Cohort 3 Dose 3

Biological: MA09-hRPE

Cohort 4

EXPERIMENTAL

Biological: MA09-hRPE Cellular therapy Cohort 4 Dose 4

Biological: MA09-hRPE

Interventions

MA09-hRPEBIOLOGICAL

Transplantation of MA09-hRPE cells accoding to the assigned dose group

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male or female over 55 years of age. Patient should be in sufficiently good health to reasonably expect survival for at least four years after treatment
  • Clinical findings consistent with advanced dry AMD
  • GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA.
  • No evidence of current or prior choroidal neovascularization in the treated eye
  • The visual acuity (BCVA) of the eye to receive the transplant found to be eligible for trial based on study protocol
  • Electrophysiological findings consistent with advanced dry AMD.
  • Medically suitable to undergo vitrectomy and subretinal injection.
  • Medically suitable for general anesthesia or waking sedation, if needed.
  • Medically suitable for transplantation of an embryonic stem cell line

You may not qualify if:

  • Presence of active or inactive CNV in the eye to be treated.
  • Presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serious choroidopathy, diabetic retinopathy or other retinal vascular or degenerative disease other than ARMD.
  • History of optic neuropathy.
  • Macular atrophy due to causes other than AMD.
  • Presence of glaucomatous optic neuropathy in the study eye, uncontrolled IOP, or use of two or more agents to control IOP (acetazolamide, beta blocker, alpha-1-agonist, prostaglandins, anhydrous carbonic inhibitors)
  • Cataract of sufficient severity likely to necessitate surgical extraction within 1 year.
  • History of retinal detachment repair in the study eye.
  • History of myocardial infarction in previous 12 months.
  • History of diabetes mellitus.
  • History of cognitive impairments or dementia which may impact the patients ability participate in the informed consent process and to appropriately complete evaluations.
  • Any immunodeficiency.
  • Any abnormalities in laboratory test result.
  • Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
  • Current participation in any other clinical trial.
  • Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 463-712,, South Korea

Location

Study Officials

  • Yeong je Seong

    CHA Bundang Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2012

First Posted

August 29, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

KR(1)