Happy Holidays! I hope you are enjoying this exciting season with family, friends, colleagues, and lots of holiday cheer. As you celebrate and reflect on a prosperous 2016, we have posted new stem cell industry coverage to help you prepare for 2017. This week in stem cells we cover cell therapy in Asia, exosomes going exponential, a massive $225M series A financing, and much more. [Read more…]
International Stem Cell Corporation Announces Second Patient with Parkinson’s Disease Treated in Phase I Clinical Trial
– Second patient of first cohort treated with ISC-hpNSC –
CARLSBAD, Calif., Dec. 07, 2016 (GLOBE NEWSWIRE) — International Stem Cell Corporation (OTCQB:ISCO), a California-based clinical stage biotechnology company developing stem cell-based therapies and biomedical products, today announced the treatment of the second patient in the Australian trial for Parkinson’s Disease. The patient was injected with 30,000,000 ISC-hpNSC® cells and is currently recovering.
The surgery was performed on Sunday, December 4, at the Royal Melbourne Hospital (RMH), the same site as the first treatment. The operation was successfully performed without complications by the team of the RMH neurosurgeons.
“We are very encouraged by how the clinical trial is moving ahead,” commented Russell Kern, PhD, executive vice president and chief scientific officer of ISCO. “The second operation was delayed by a supply chain disruption of equipment critical to the operation, but we have managed to fix the issue and bring the clinical trial back on track. In addition, we have identified patients to be enrolled in the trial and are working to get them treated in 2017.”
About the clinical study
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. [Read more…]
SanBio, a stem cell and regenerative medicine company specializing in neurological disorders, announced that it has been issued a key patent by the Australian Patent Office covering its proprietary modified stem cells, SB623, for the treatment of traumatic brain injury. Australian Patent No. 2013263417 was formally issued on September 8, 2016.
To secure its proprietary technology, SanBio filed a global patent application for it modified stem cells (SB623), doocumenting its ability to support regenerative processes in the central nervous system (CNS). The patent also documents the ability of these cells to provide therapeutic support for a range of neurological disorders, including traumatic brain injury (TBI).
Australia was the first country to grant the patent to SanBio. The company is also seeking patent protection in other regions.
According to Dr. Damien Bates, Chief Medical Officer and Head of Research at SanBio, “There are 5.3 million people living with chronic disabilities from traumatic brain injury in the United States and more than 700,000 in Australia. We hope that SanBio’s regenerative medicine, SB623, will be able to serve as a treatment option for these patients.”
Below is a press release from Santa Clara Valley Medical Center (SCVMC), a site in the AST-OPC1 SCiSTAR Phase 1/2a clinical trial in complete cervical spinal cord injury, which is being sponsored by BioTime, Inc. (NYSE MKT: BTX) subsidiary Asterias Biotherapeutics (NYSE MKT: AST).
The clinical trial will test the safety of three varying doses of AST-OPC1, which are oligodendrocyte progenitors that have the capacity to differentiate into a variety of brain cells. The California Institute of Regenerative Medicine (CIRM) also released a blog post about the procedure conducted at SCVMC.
The SCiSTAR study being run by Asterias Biotherapeutics is funded in part by a $14.3 million grant from CIRM. [Read more…]
The Food and Drug Administration has announced a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.” [Read more…]