International Stem Cell Completes Enrollment & Dosing in its Parkinson’s Disease Clinical Trial
International Stem Cell Corporation recently announced the completion of subject enrollment in its Phase 1 clinical trial of ISC-hpNSC for the treatment of Parkinson’s disease. 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. This clinical trial, which involved 12 patients with Parkinson’s disease, was conducted in collaboration with investigators from Royal Melbourne Hospital, a leading medical institution with an international reputation for excellence.
“We are excited to announce the completion of enrollment of the world’s first approved human pluripotent stem cell-based clinical trial for the treatment of Parkinson’s disease. This is a major milestone for the company, and we expect to announce complete clinical results of this Phase 1 clinical trial in the first half of 2020,” said ISCO’s Co-Chairman and CEO Andrey Semechkin, PhD. “In addition, now that we have completed the most expensive stage of the Phase 1 clinical trial, ISCO will have more resources available to invest in growing and developing its commercial business, where we have recently made significant progress.”
The goal of this 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, which is a very 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.
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 free 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 neuroregeneration to the dying dopaminergic neurons of the recipient Parkinson’s disease brain. Additionally, ISC-hpNSC is safe, well tolerated and has shown not to 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 pluripotent human 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 hundreds of 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). For more information, visit www.internationalstemcell.com.
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