Brainstorm Cell Therapeutics (BCLI)
605 Third Avenue, 34th Floor
New York NY 10158
Tel: (646) 666-3188
12 Bazel St., POB 10019 Kiryat Aryeh,
Petach Tikva, Israel 49001
BrainStorm Cell Therapeutics (OTC.QB: BCLI) is a biotechnology company developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Multiple Sclerosis (MS) and Parkinson’s Disease (PD).
The company holds the rights to develop and commercialize NurOwn through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University.
We are proud to announce that we have received FDA approval for commencement of our multi-center Phase II trial for ALS in the United States.
NurOwn™ is our proprietary, first-of-its-kind technology that induces autologous bone marrow-derived Mesenchymal Stem Cells (MSCs) to secrete Neurotrophic Factors (NTF). The NurOwn treatment approach is to transplant these “MSC-NTF” cells back into the patient at or near the site of damage, in the spine and/or muscles.
In 2013 we conducted a Phase IIa ALS clinical trial with NurOwn at the Hadassah University Medical Center in Jerusalem. In this safety and preliminary efficacy trial, patients received combined intramuscular and intrathecal administration of NurOwn cells in three cohorts with increasing doses. The study participants were followed for six months after transplantation.
The company has recently launched a Phase II clinical trial in the USA.
NurOwn was granted Orphan Drug designation by the US FDA and the European Commission (EC).
Over 20 publications in leading scientific journals demonstrating NurOwn's mechanism of action, pharmacology and in vivo efficacy have been published by the scientific team.
US Clinical Trials
In June 2014, BrainStorm launched a multi-center Phase II clinical trial in the United States. The participating clinical centers are Massachusetts General Hospital (MGH), the University of Massachusetts (UMass) Memorial Hospital, and the Mayo Clinic.
BrainStorm’s Phase II trial is a randomized, double-blind, placebo controlled multi-center study designed to evaluate the safety and efficacy of transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors ("MSC-NTF" or NurOwn™) in 48 ALS patients.
The trial protocol, eligibility criteria, and contact details are listed at the following link:
Potential candidates that are eligible for the trial may submit a request for information about participation directly to the clinical centers. Unfortunately we are not authorized to provide any treatments outside of our clinical trials right now.
The UMass team will be led by Professor Robert H. Brown, MD, DPhil., Chair of the Neurological Department. Professor Brown is a leading expert in neuromuscular genetics and is world renowned for his expertise in ALS.
The MGH team will be led by Prof. Merit Cudkowicz, MD, MSc, an expert in clinical trial design and therapy development for neurodegenerative diseases. She co-chairs the Northeast ALS consortium and directs the MGH Neurological Clinical Research Institute (NCRI).
The Mayo Clinic team will be led by Professor Anthony J. Windebank, MD, Head of the Regenerative Neurobiology Laboratory in the Department of Neurology. Prof. Windebank specializes in the diagnosis and treatment of patients with diseases of the peripheral nervous system and spinal cord.
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