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
CARLSBAD, Calif., Dec. 07, 2016 — 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.
About Parkinson’s disease
Parkinson’s disease (PD) is a degenerative disorder of the central nervous system mainly affecting the motor system. The motor symptoms of Parkinson’s disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain. Early in the course of the disease, the most obvious symptoms are movement-related; these symptoms include shaking, rigidity, slowness of movement and difficulty with walking and gait. Later, thinking and behavioral problems may arise, with dementia commonly occurring in the advanced stages of the disease, and depression is the most common psychiatric symptom. Parkinson’s disease is more common in older people, with most cases occurring after the age of 50.
Currently, medications typically used in the treatment of Parkinson’s, L-DOPA and dopamine agonists, improve the early symptoms of the disease. As the disease progresses and dopaminergic neurons continue to be lost, the drugs eventually become ineffective while at the same time frequently producing a complication marked by involuntary writhing movements. In 2013 PD resulted in about 103,000 deaths globally, up from 44,000 deaths in 1990.
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.
About International Stem Cell Corporation
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.
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…]