ISCO Completes Enrollment, Dosing In Parkinson's Trial.
CARLSBAD, Calif, April 29, 2019 -- International Stem Cell Corporation (OTCQX:ISCO) said it has completed subject enrollment in its phase 1 clinical trial of ISC-hpNSC for the treatment of Parkinson's disease.
The trial, which involved 12 Parkinson's patients, was conducted with investigators from Royal Melbourne Hospital.
The fourth subject of the third cohort, who was the twelfth and final subject of the phase 1 clinical study, was successfully transplanted with the highest dose of ISC-hpNSC cells.
According to the company, the trial is the world's first approved human pluripotent stem cell-based clinical trial for the treatment of Parkinson's disease.
"We expect to announce complete clinical results of this phase 1 clinical trial in the first half of 2020," CEO Andrey Semechkin.
Completion of the trial frees up resources "to invest in growing and developing [our] commercial business," Semechkin added.
The goal of the study is to assess the safety and incidence of treatment-emergent adverse events after intracerebral transplantation of 30 million, 50 million, and 70 million ISC-hpNSC cells into the substantia nigra and striatum of patients with Parkinson's disease.
Thus far there have been no serious adverse events related to the transplanted ISC-hpNSC, a significant achievement due to the invasive nature of the transplantation procedure.
Preliminary efficacy is also evaluated through secondary endpoints, although no definitive conclusions can be drawn due to the fact that this is a clinical study with no placebo control group.
Secondary endpoints assess the change from baseline in different neurological scales such as Unified Parkinson's Disease Rating Scale, Parkinson's Disease Quality of Life Questionnair-39, and Patient motor diary.
After transplantation, patients are evaluated for 12 months (active phase of the study) with an additional 5-year observational follow-up period to assess the safety of ISC-hpNSC.
Eight patients have already completed the 12-month study and entered the follow-up phase.
Interim results of the study will be presented at the American Academy of Neurology 71 annual meeting in Philadelphia, Pa. on May 5.
More than 10 million people worldwide are afflicted with Parkinson's disease. In 2013 Parkinson's disease resulted in about 103,000 deaths, globally. In 1990, the death toll recorded was 44,000.
ISC-hpNSC consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells.
The drug is a suspension of clinical grade cells manufactured under cGMP conditions that have undergone stringent quality control measures and are free of any microbial and viral contaminants.
ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs).
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|Publication:||Stem Cell Business News|
|Date:||Apr 29, 2019|
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