Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD
Long Term Follow up to A Phase I/II, Open-Label, Multi-Center, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (MA09-hRPE) Cells in Patients With Advanced Dry AMD
2 other identifiers
observational
11
1 country
4
Brief Summary
The purpose of his study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry Age-Related Macular Degeneration (AMD) from one to five years following the surgical procedure to implant the MA09-hRPE cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2013
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2013
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2019
CompletedOctober 31, 2024
October 1, 2024
6.5 years
May 13, 2015
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety assessed by Adverse Events (AEs) of special interest in regards to the investigational product
This will include obtaining information about ophthalmological findings and Serious Adverse Events (SAEs) that are neurologic, infectious, hematologic or fatal, pregnancy in a female subject or the partner of a male subject and pregnancy outcome, any Adverse Event (AE) that causes a subject to withdraw from the study, any new diagnosis of an ocular or immune-mediated disorder, cancer, ectopic or proliferative cell growth (Retinal pigment epithelium (RPE) or non-RPE) with adverse clinical consequence, and unexpected, clinically significant AEs possibly related to the cell transplant procedure or the investigational product (MA09-hRPE cells).
4 years
Secondary Outcomes (2)
Incidence of graft failure or rejection
4 years
Number of patients with changes in ocular examinations or images
4 years
Study Arms (1)
MA09-hRPE
Experimental: Subretinal injection of MA09-hRPE * Cohort 1 50,000 cells * Cohort 2 100,000 cells * Cohort 2a Better Vision 100,000 cells * Cohort 3 150,000 cells * Cohort 4 200,000 cells
Interventions
Cohort 1 50,000 cells Cohort 2 100,000 cells Cohort 2a Better Vision 100,000 cells Cohort 3 150,000 cells Cohort 4 200,000 cells
Eligibility Criteria
The study population is by invitation only for previous participants in the core protocol
You may qualify if:
- Must have been treated with hESC-RPE cell transplant in the core protocol.
- Able to understand and willing to sign the informed consent to participate in the follow up study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Jules Stein Eye Institute, UCLA School of Medicine
Los Angeles, California, 90095, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Mass Eye and Ear
Boston, Massachusetts, 02114-3002, United States
Wills Eye Institute-Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Related Publications (2)
Schwartz SD, Hubschman JP, Heilwell G, Franco-Cardenas V, Pan CK, Ostrick RM, Mickunas E, Gay R, Klimanskaya I, Lanza R. Embryonic stem cell trials for macular degeneration: a preliminary report. Lancet. 2012 Feb 25;379(9817):713-20. doi: 10.1016/S0140-6736(12)60028-2. Epub 2012 Jan 24.
PMID: 22281388RESULTSchwartz SD, Regillo CD, Lam BL, Eliott D, Rosenfeld PJ, Gregori NZ, Hubschman JP, Davis JL, Heilwell G, Spirn M, Maguire J, Gay R, Bateman J, Ostrick RM, Morris D, Vincent M, Anglade E, Del Priore LV, Lanza R. Human embryonic stem cell-derived retinal pigment epithelium in patients with age-related macular degeneration and Stargardt's macular dystrophy: follow-up of two open-label phase 1/2 studies. Lancet. 2015 Feb 7;385(9967):509-16. doi: 10.1016/S0140-6736(14)61376-3. Epub 2014 Oct 15.
PMID: 25458728RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Institute for Regenerative Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2015
First Posted
June 4, 2015
Study Start
February 25, 2013
Primary Completion
August 19, 2019
Study Completion
August 19, 2019
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.