International Stem Cell Corp. (ISCO), a California based clinical-stage company has announced that the first two patients in its Phase 1 trial in Parkinson’s disease has successfully undergone intracranial neural stem cell transplants.
Parkinson’s disease is a neurodegenerative disorder involving loss of neurons that release dopamine in the striatum. Levodopa medication is the standard treatment prescribed to patients to compensate for the loss of dopamine.
The present Phase 1 study is designed as a single arm, open-label study to evaluate the safety and tolerability of ISC-human parthenogenetic neural stem cells (hpNSC) injected intracerebrally into the striatum and substantia nigra of patients with Parkinson’s disease. The study will enrol 12 patients at three dosing regimens; 4 patients each for the three different doses. The primary endpoint of the study is safety but will also gather preliminary efficacy data measured at six and 12 months following the treatment. Patients on the study will be treated with 30 million to 70 million stem cells, delivered via intracranial injection.The trial conducted at the Royal Melbourne Hospital in Australia is expected to complete in 2018.
ISCO had treated the first patient in July, but additional surgical procedures were delayed by “a supply chain disruption of equipment critical to the operation,” according to Russell Kern, ISCO’s CSO.
The company will use data obtained from the study to design a future Phase 2 trial, which is expected to initiate in late 2017 or 2018.
Source: After delay, ISCO’s trial of Parkinson’s stem cell therapy gets underway again. Press Release