Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD
Launched by ASTELLAS INSTITUTE FOR REGENERATIVE MEDICINE · Jun 2, 2015
Trial Information
Current as of September 14, 2025
Completed
Keywords
ClinConnect Summary
This study is a long term, follow up to the ACT MA09-hRPE 001 phase I/II trial. The phase I/II trial (referred to as the core protocol) was an open-label, non randomized, dose escalation, multi-center trial. Thirteen AMD patients were treated in this trial. Ten patients with profound vision loss (visual acuity \<= 20/400) received a single subretinal injection of MA09-hRPE cells, starting at a dose of 50,000 MA09-hRPE cells transplanted (three patients), 100,000 MA09-hRPE cells transplanted (three patients), 150,000 MA09-hRPE cells (three patients) and increasing to a maximum dose of 200,00...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • - There are no exclusion criteria.
About Astellas Institute For Regenerative Medicine
Astellas Institute for Regenerative Medicine (AIRM) is a leading biopharmaceutical organization dedicated to advancing transformative therapies in regenerative medicine. As a subsidiary of Astellas Pharma, AIRM focuses on pioneering research and development aimed at addressing unmet medical needs through innovative cell-based treatments. With a commitment to scientific excellence and patient-centered approaches, AIRM strives to harness the power of regenerative medicine to improve health outcomes and enhance the quality of life for patients worldwide. Through collaborative efforts and cutting-edge technology, AIRM is at the forefront of developing solutions that aim to restore function and promote healing across a range of diseases and conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Los Angeles, California, United States
Philadelphia, Pennsylvania, United States
Boston, Massachusetts, United States
Patients applied
Trial Officials
Medical Director
Study Director
Astellas Institute for Regenerative Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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