ACT’s European Clinical Trial Advances To First Patient Treatment With Higher Dosage Of Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in its European 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 50,000 cells in the three patients comprising the first cohort. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.
“Our progress continues in our European clinical trial and both our trials in the U.S., as seen most recently with last week’s announcement of treatment of the second patient in the second patient cohort of our U.S. trial for SMD,” said Gary Rabin, chairman and CEO of ACT. “As I mentioned last week, we have mapped out the series of patients to complete the second cohort of both our trials for SMD, as well as for our trial for dry age-related macular degeneration (dry AMD), pending DSMB review, and we anticipate generating patient data at a faster pace.”
Initiated in January of this 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 another trial for SMD and one for dry AMD, both in the U.S.
“We are very gratified to be initiating the first treatment of the second patient cohort in our European clinical trial, having just started it this year,” commented Robert Lanza, M.D., ACT’s chief scientific officer. “Our two U.S. trials also continue to move steadily forward.”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 www.clinicaltrials.gov, with the following Identifiers: NCT01469832 (E.U. SMD), NCT01345006 (U.S. SMD), and NCT01344993 (dry AMD). About Stargardt’s Disease 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.
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