Clinical trial

[Shege1]

Does anyone know about this trial? International Stem Cell Corporation Announces Successful Cell Transplantation for the First Patient in Phase 1 Clinical Trial of ISC-hpNSC.

[gloriabus]

Yes

Phase I/IIa trials are being conducted in Melbourne, Australia through the Florey Institute of Neuroscience & Mental Health by Cyto Therapeutics, a wholly owned subsidary of the International Stem Cell Corporation, a listed US biotech (OTCQB.ISCO). ISCO's method is to implant human neural stem cell grafts (ISC-hpNSC®) intracranially. The company claims that "human stem cells have been shown to be as pluripotent as embryonic stem cells; however, their creation does not involve the destruction of a viable human embryo, which effectively sidesteps the controversy and ethical dilemmas associated with the use of human embryonic stem cells." The safety and efficacy trial involves 12 people with moderate to severe Parkinson's and interim results are expected "by October 2016".

However, note also the cautions about stem cell research for PD (and other neurological conditions) contained in the paper by Prof Roger A. Barker et al. "Are Stem Cell-Based Therapies for Parkinson’s Disease Ready for the Clinic in 2016?" Journal of Parkinson’s Disease 6 (2016) 57–63. The paper concludes:

"As our ability to make authentic midbrain dopaminergic neurons from stem cell sources improves, so does the reality of a first in human clinical trial in patients with PD. This is an exciting prospect but should only be undertaken when all the necessary pre-clinical data and regulatory approvals have been obtained and verified and the criteria for moving those cells to trials fully resolved and met - something that is currently a major focus of the GForce-PD consortium (gforce-pd.com/). Only too often are exaggerated claims made, based

on limited pre-clinical data and a desire to pass the financial and regulatory hurdles needed to get to clinic, sometimes driven by personal ambitions along with financial and commercial interests. Acting prematurely has the potential not only to tarnish many years of scientific work, but can threaten to derail and damage this exciting field of regenerative medicine.

Hopefully, in 2016, we are ready to take a more careful approach as we strive to repair the PD brain with stem cell-based therapies, avoiding many of the mistakes that have dogged this field over the last 3 decades."