The California-based biotech company, International Stem Cell Corporation (ISCO), has successfully completed ISC-hpNSC® neural cell transplantation in its first cohort of Parkinson’s disease patients for their Phase 1 clinical study.
ISCO is developing human parthenogenetic neural stem cells (hpNSCs) with the hope of treating a range of neurological conditions. This initial Phase 1 trial is assessing the dose escalation and preliminary efficacy of transplanting the neural stem cells, which have been derived from human parthenogenetic stem cells, in subjects with moderate Parkinson’s disease. The trial conducted at the Royal Melbourne Hospital in Australia will test three dose regimens between 30,000 and 70,000 ISC-hpNSC® cells injected intracerebrally into the striatum and substantia nigra of patients with Parkinson’s disease. The recent update is a positive start for the trial, with no patients experiencing adverse events and all of the transplantation operations going according to plan.
The death of dopaminergic neurons is the cause of the motor symptoms associated with Parkinson’s disease. The transplantation of pure neural cells therefore has the potential to provide neurotrophic support and neuroregeneration to the affected tissues of the recipient brain. This would be a first in the efforts to treat the disease as no current approaches target the restoration of the damaged dopaminergic neurons. Preclinical studies of ISC-hpNSC® 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 the therapy. A further plus found in preclinical models was the absence of adverse events such as dyskinesia, system toxicity or tumors.
Russell Kern, executive VP and CSO of ISCO commented: “We look forward to dosing our second cohort with 50 million cells and enrolling the rest of our clinical trial participants in 2017. The Data Safety Monitor Board meeting will be held in the beginning of May and we expect to receive approval to start an accelerated enrollment of patients into the second cohort.”
Source: International Stem Cell Corporation Completes First Cohort In Parkinson’s Disease Clinical Trial; Press Release