The world of ALS patients and their families focuses on the most current research, theories, clinical trials taking place, potential treatment opportunities and symptom relief availability. While a great deal of information is available on this website, current updates with the most recent information can be read here. At times, brief statements are offered as well as links to other websites for in depth explanations. Steve will do his best to keep information current as he combs the internet, visits with researchers, explores bio-medical facilities and meets with patients and their families.
PRECISION STEMCELL REPORT UPDATE
Dr. Leigh Turner, one of the nation's foremost bioethicists, has recently reaffirmed the conclusions drawn by Dr. Peiman Hematti and Stephen Byer about the Precision StemCell procedure. Previously unknown to ALSWW, Dr. Turner had already investigated Precision StemCell in December, 2012. His letter, Written Notice to FDA, in which his concerns are extensively detailed, can be read in its entirety. Interestingly, these two totally independent investigations are remarkably parallel, citing the same concerns. We appreciate this highly regarded bioethicist, pharmacologist and stem cell researcher for allowing us to reprint his investigatory letter to FDA.
In February 2013, Dr. Peiman Hematti and Stephen Byer determined that the Precision StemCell procedure is both ineffective and potentially dangerous. Dr. Jason Williams stated his intention to discontinue this procedure in the U.S. However, he plans to move his operation to Bogota, Colombia. The complete discussion can be reviewed in detail at Precision StemCell. Dr. Leigh Turner also wrote about Precision Stem Cell on his blog, Health in the Global Village, in a post entitled "Precision StemCell: Selling Stem Cells & Treating Individuals with ALS as Human Guinea Pigs."
Encouraging Results in BrainStorm's NurOwn Clinical Trial, Israel
On March 20th, 2013, during the 65th Annual Meeting of the American Academy of Neurology (AAN), BrainStorm Cell Therapeutics, an Israeli developer of adult stem cell technologies for neurodegenerative diseases, reported positive results from their Phase I/II clinical trial, which evaluated the company’s NurOwn technology in ALS patients. Principal Investigator and Prof. Dimitrios Karussis, Head of the Neuroimmunology Laboratory at Hassadah Medical Center in Jerusalem, reported that the six patients who received an intrathecal stem cell injection experienced a significantly slower decline in clinical and respiratory function in the six months following treatment, as compared to the three months preceding treatment. In addition to providing positive indications for efficacy, the trial also established the safety of the treatment, which is the principal goal for all Phase I clinical trials.
After the disappointment surrounding ALS WORLDWIDE’s investigation of Precision StemCell, this news is a heartening reminder of the potential that stem cell technology holds for ALS patients. BrainStorm is continuing its development of NurOwn technology. As stated by Alon Natanson, Chief Executive Officer, “We are excited by these data and the potential of NurOwn to positively impact the lives of patients with ALS, [and] we look forward to continuing to advance this potentially important therapy. To that end, we have begun a Phase IIa dose-escalating trial at Hadassah and plan to launch a multi-center Phase II trial in the USA later this year in order to further validate the results that were presented today.”
Brainstorm's US clinical trials are already scheduled at University of Massachusetts, Massachusetts General Hospital and Mayo Clinic, Rochester, MN and may begin as early as mid-2013. We urge patients and caregivers to carefully and thoroughly explore these trials as a means of both contributing to ALS research and to hopefully alleviate symptom progression, as has been suggested by the analysis of the Phase I/II trial results at Hadassah Medical Center.
ALS WORLDWIDE representatives will meet with NurOwn in Israel during April, 2013, as they have each of the past several years, to better understand the state of their research and its further implementation on behalf of those with ALS. It is expected that much more information will be transmitted through the ALS WORLDWIDE website and newsletters immediately after the upcoming meetings. To read about the results of the BrainStorm trial in greater detail, see the AAN poster here.
NEWLY DISCOVERED BIOMARKER FOR LOU GEHRIG'S DISEASE COULD LEAD TO NEW THERAPY click here to read article