Stem cells will be certainly in the news this year as several clinical trials for spinal cord injury are underway, or planned.
StemCells, Inc. Trial to Canada
StemCells, Inc. enrolled its first North American patient for neural stem cell transplantation to treat spinal cord injury. As we have followed from day one, the California company began this SCI stem cell safety trial in Switzerland two years ago. The trial is based on animal studies
from the University of California, Irvine lab of Reeve International Research Consortium member Aileen Anderson and her husband, Brian Cummings
The first eight patients – each three months to a year post-injury – were dosed with human fetal-derived neural stem cells at Balgrist Universtiy Hospital in Zurich; early results showed modest sensory recovery in at least two. Last year the company got permission from Canadian and U.S. regulatory agencies to bring the trial to North America. The first person enrolled was Alex Petric, 29, from Winnepeg, who injured his spinal cord last year diving into an unseen sandbar in Panama. A team in Calgary injected him with neural stem cells a few days ago. Here’s more
from a local TV station, including a bit of context from neurosurgeon scientist Michael Fehlings, who advises cautious hope for what he terms “a major advance” and “a big deal.”
From StemCells President and CEO, Martin McGlynn:
Using the encouraging safety and efficacy data obtained from the Swiss trial, in 2013 we sought and obtained approval from Health Canada and the FDA to expand the study into North America, the largest market in the world for spinal cord injury. We did so to accelerate completion of the current study, and so we are confident that we will wrap up enrollment in Q1 2014, which should pave the way for the controlled Phase II efficacy trial that we plan to initiate by the middle of 2014.
The StemCells line is also currently being studied in a Phase I/II trial for dry age-related macular degeneration at the Retina Foundation of the Southwest, in Dallas,
Neuralstem raises some dough:
We reported a year ago today
that Neuralstem had gotten the green light for a trial of its line of neural stem cells for chronic spinal cord injury. The cells, called NSI-566, have been used for several years with no adverse effects in Phase I and II trials for ALS. Although five centers were named to host the SCI trial (Shepherd Center, Atlanta; University of Miami; Thomas Jefferson University Hospital in Philadelphia; Wisconsin Medical College of Milwaukee; UC San Diego) there has still been no one enrolled. Neuralstem says the SCI trial should begin first quarter of the new year. Why the delay? Let’s assume technology and regulatory issues are non-issues. That pretty much leaves money to blame. Good news for CUR (the Neuralstem stock exchange name): $20 million was just raised from institutional and accredited investors (see this link
) in a registered direct placement, with warrants that might add another $12.5 million.
Geron’s stem cells, redux:
Three months ago the rights to the cell line that was featured in the first ever human embryonic stem cell trial were officially transferred to Asterias Biotherapeutics
, a subsidiary of BioTime, operated by founders of Geron. Asterias acquired Geron’s human embryonic stem cell assets, as well as rights to use certain human embryonic stem cell lines. No announcement has been made regarding timing but the company indicates in press releases that it hopes to resume the acute SCI trial Geron abandoned two years ago.