ACT Announces Second Patient with Dry AMD Treated in U.S. Clinical Trial with RPE Cells Derived from Embryonic Stem Cells
ACT Announces Second Patient with Dry AMD Treated in U.S. Clinical Trial with RPE Cells Derived from Embryonic Stem Cells
Two Clinical Trial Sites Now Approved to Participate in Clinical Trial for Dry AMD
MARLBOROUGH, Mass.--(BUSINESS WIRE)--
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the second patient was dosed in the Company’s Phase I/II trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient is recovering uneventfully.
“We are very pleased to announce that the treatment of the second dry AMD patient went very well, without any complications,” said Gary Rabin, chairman and CEO of ACT. “We are delighted with our ongoing progress in all of our clinical trials using our stem cell-derived RPE cells to treat forms of macular degeneration. So far, there have not been any complications or side effects due to the stem cell-derived RPE cells, and we will continue monitoring the patients for safety, tolerability and efficacy of this therapy.”
The dry AMD trial is one of three clinical trials being carried out by the company in the U.S. and in Europe. Each trial will enroll 12 patients, with cohorts of three patients in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD or Stargardt's macular dystrophy (SMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet.
Further information about patient eligibility for the dry AMD study and the concurrent study on SMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.
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