The regulatory equivalents of the FDA in Switzerland, and now Canada, have approved a human neural stem cell trial for people with spinal cord injuries three to 12-months post-injury. The FDA? Well, no, not yet.
It was announced by StemCells, Inc. today that Health Canada authorized the company to expand its Phase I/II clinical trial for SCI. The trial, currently underway in Zurich, is looking at the safety and any signs of efficacy for a line of purified human neural stem cells. No Canadian trial sites have been announced.
For more on this trial, see our blog about Aileen Anderson
, the Reeve International Research Consortium member who developed the cells for the company. For trial detail, check out www.clinicaltrials.gov
So far four people have gotten these cells in Zurich. The first three were complete injuries, so-called ASIA As. The company has reported no safety issues; however, two “showed multi-segment gains in sensory function,” according to the company. One patient converted from complete to incomplete injury.
The fourth patient was an incomplete paraplegic; there’s been no word on any change in status.
While any kind of recovery is good news, enthusiasm must be tempered by the very small sample size and because this was an “open label” study – there were no controls to mute the power of placebo. The following is from the StemCells, Inc. press release
, containing all the cautions an investor – or potential patient – must keep in mind.
[These] statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the fact that additional trials will be required to demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether the FDA, Health Canada or other applicable regulatory agencies will permit the Company to continue clinical testing in spinal cord injury or in future clinical trials of proposed therapies for other diseases or conditions; uncertainties regarding the ability of preclinical research, including research in animal models, to accurately predict success or failure in clinical trials; uncertainties regarding the Company's ability to recruit the patients required to conduct its clinical trials or to obtain meaningful results; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Company's cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding the Company's ability to commercialize a therapeutic product and its ability to successfully compete with other products on the market; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report.
More from StemCells, Inc.:
If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at email@example.com