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NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. NurOwn® is not currently approved in the United States, Israel or elsewhere. There is no guaranty that this treatment will be effective or that there will not be any adverse effects for patients as a result of this treatment. Brainstorm - Phase 2 Study Results
To advance and accelerate the leading ALS adult stem cell science in Canada requires many hands. We've got many successes under our belt, but we need more help, and that's where you come in.
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CCRM is providing BrainStorm regulatory consulting. Patrick Bedford, manager of clinical translation and regulatory affairs, CCRM adds: “Health Canada is a world-class regulator that can use special regulatory pathways to review safety data and preliminary efficacy data to authorize promising therapies, while awaiting the completion of confirmatory efficacy studies. In fact, ALS has been specifically identified by Health Canada as a serious condition with unmet clinical needs that may qualify for a special regulatory pathway. If Brainstorm’s existing clinical trial data can be found sufficient, NurOwn could be distributed to Canadians by next year.”
Feb 21st, 2017 - BrainStorm-Cell Therapeutics (NASDAQ: BCLI) Seeking Health Canada Approval To Distribute NurOwn® in Canada. BrainStorm signs agreement with CCRM for regulatory support of ALS treatment. Health Canada considering "Notice of Compliance with Conditions” in effort to provide world-leading NurOwn® stem cell treatment to Canadian ALS patients. BrainStorm Official Press Release / Adaptive Canuck ALS Foundation Official Press Release
Health Canada Early Access Pathway for treatment of patients with Amyotrophic Lateral Sclerosis (ALS). If NurOwn® qualifies for Health Canada’s “Notice of Compliance with Conditions” pathway, it could be authorized in Canada for distribution in early 2018.
NurOwn® uses proprietary culture conditions to induce mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors known to promote the survival of neurons (nerve cells). The product is manufactured using a process that involves taking a sample of bone marrow from a patient and then sending the bone marrow to a manufacturing facility where MSCs are isolated and grown under carefully managed conditions. At the end of this process NurOwn® is harvested, placed into syringes and is ready to be delivered to the patient for an intrathecal administration. www.brainstorm-cell.com
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