Montreal, Canada, May 4, 2017 – Fortuna Fix Inc., (“Fortuna”), a private, clinical-stage biotech company is aiming to be the first to eliminate the need for embryonic and fetal stem cells by using direct reprogramming of autologous cells to treat neurodegenerative diseases. Fortuna announced today the launch of its Scientific Advisory Board (“SAB”) with Professor Michael Fehlings, MD, PhD, Father Kevin FitzGerald, S.J., PhD, COL (R) Dallas Hack, MD, MPH, and Professor James Giordano, PhD. [Read more…]
While our other global strategic reports provide targeted analysis of a single stem cell type, “Stem Cell Research Products – Opportunities, Tools, & Technologies” is an overview report that evaluates strategies across the entire stem cell product spectrum, with emphasis on opportunities for research product development. [Read more…]
What do we know of the safety and efficacy of stem cell therapeutics?
Over 50 years have passed since the discovery of hematopoietic stem cells (bone marrow transplantation to cure diseases such as leukemia), almost 20 years since the discovery of human embryonic stem cells (hESC), and 10 years since the discovery of induced pluripotent stem cells (iPS cells). There are also more than 5,000 stem cell trials ongoing in clinics globally. Despite this experience, what do we actually know about the safety and efficacy of stem cell therapeutics?
In this novel and increasingly complex stem cell space, it is perhaps a timely question to ask, especially since the regulatory assessment criteria designed for conventional medicines are not directly applicable for stem cell therapy. [Read more…]
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…]