Fifth Patient in U.S. Clinical Trial Injected with 100,000 RPE Cells
ACT Announces Second Stargardt’s Disease Patient Treated with Higher Dosage of Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells
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Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fifth patient, the second in the second patient cohort, in its U.S. clinical trial for Stargardt’s Macular Dystrophy (SMD). The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE) cells, as compared with the 50,000 cell dose used in the three patients of the first cohort. The patient successfully underwent the outpatient transplantation surgery yesterday, and is recovering uneventfully.
“We continue to make steady progress in our ongoing clinical trials,” commented Gary Rabin, chairman and CEO. “We look forward to completing the third and final patient in this cohort in the U.S. clinical trial for SMD in the near future, which will mark the halfway point. We have now mapped out the series of patients to complete this cohort and the second cohort in the European trial, and have done the same in the US AMD trial, pending DSMB review. With all four trial centers in the US and both trial centers in the UK now trained and ready to treat patients, combined with the streamlined process in the European trial protocol, we anticipate an accelerated pace of generating patient data.”
Initiated in July of last year, the Phase I/II trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the study’s primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format. The company is concurrently conducting a second trial for SMD in Europe and another for dry age-related macular degeneration in the U.S.
“We continue to be very encouraged with how this clinical trial is progressing,” said Robert Lanza, M.D., chief scientific officer. “We are confident of continued momentum in our other two trials, as well.”
Further information about patient eligibility for ACT’s SMD study and the concurrent studies in the U.S. and Europe (for dry age-related macular degeneration and SMD, respectively) are available at , with the following Identifiers: NCT01345006 (U.S. SMD), NCT01344993 (dry AMD), and NCT01469832 (E.U. SMD).
Stargardt’s disease or Stargardt’s Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit .