International Stem Cell Corporation Announces Third Patient With Parkinson’s Disease in Clinical Trial
International Stem Cell Corporation recently announced the third patient in the clinical trial for Parkinson’s Disease was successfully transplanted with ISC-hpNSC cells and is already discharged from the Royal Melbourne Hospital (RMH). The operation was successfully performed without complications by the team of the RMH neurosurgeons.
“The third operation went according to plan, and we are on track to dosing all of our clinical trial participants in 2017. We have enrolled the fourth patient, and we expect to perform the surgery in March. No test article related adverse events have been recorded for any of the patients transplanted in 2016,” said Russell Kern, PhD, Executive Vice President and Chief Scientific Officer of ISCO.
The Phase I clinical study is a dose escalation safety and preliminary efficacy study of ISC-hpNSC, intracranially transplanted into patients with moderate-to-severe Parkinson’s disease. The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens of 30,000,000 to 70,000,000 neural cells. A total of 12 participants with moderate-to-severe Parkinson’s disease will be treated. Following transplantation, the patients will be monitored for 12 months at specified intervals, to evaluate the safety and biologic activity of ISC-hpNSC. PET scan will be performed at baseline, as part of the screening assessment, and at 6 and 12 months after surgical intervention. Clinical responses compared to baseline after the administration of ISC-hpNSC will be evaluated using various neurological assessments, such as Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr, and other rating scales.
International Stem Cell Corporation’s proprietary ISC-hpNSC consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells. ISC-hpNSC is a suspension of clinical-grade cells manufactured under cGMP conditions that have undergone stringent quality control measures and are clear of any microbial and viral contaminants. Preclinical studies in rodents and non-human primates have shown improvement in Parkinson’s disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC. ISC-hpNSC provides neurotrophic support and cell replacement to the dying dopaminergic neurons of the recipient PD brain. Additionally, ISC-hpNSC is safe, well tolerated, and does not cause adverse events, such as dyskinesia, systemic toxicity, or tumors in preclinical models. International Stem Cell Corporation believes that ISC-hpNSC may have broad therapeutic applications for many neurological diseases affecting the brain, the spinal cord, and the eye.
International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of human pluripotent stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for millions of individuals of differing genders, ages, and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
Total Page Views: 687