The research, which appears in the online edition of “Stem Cells and Development” is the second recent peer-reviewed publication demonstrating the potential promise of BrainStorm’s technology, which induces human adult stem cells to become cells that release Neurotrophic Factors (NTF cells). A publication last month by the same scientific team documented that engrafted human NTF cells survived and expressed neuronal markers after 120 days and acted to regenerate the damaged dopaminergic nerve system in the same rodent model of Parkinson’s disease.
Today’s findings resulted from experiments conducted by Dr. Daniel Offen in collaboration with colleagues at BrainStorm and at the Tel-Aviv University. They demonstrate that cells processed using BrainStorm’s technology produce and secrete significant amounts of essential factors for brain cell function, including Glial cell line-Derived Neurotrophic Factor (GDNF) and Brain-Derived Neurotrophic Factor (BDNF). Moreover, the cells transplanted into the standard rodent model of Parkinson's disease, reduced the motor dysfunction by 50%, inhibited the induced dopamine depletion and restored the dopaminergic cell's terminals. In lay terms, all of those findings are consistent with attenuating the tremor and other motor symptoms associated with Parkinson’s disease.
In addition to the marked improvement in symptoms, the study also demonstrated via Magnetic Resonance Imaging (MRI) and subsequent histological assessment that the transplanted cells migrated toward the experimentally-induced lesion, indicating both their survival and integration into brain tissue.
Prof. Eldad Melamed, Professor of Neurology at the Tel Aviv University and BrainStorm’s Chief Medical Advisor adds, "On the basis of our findings, we suggest that autologous transplantation of NTF cells, originally derived from a patient's own bone marrow, may become a novel and potent treatment for Parkinson's disease and other neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis (ALS)."
The use of adult stem cells avoids recently demonstrated concerns of tumor growth in association with fetal stem cell implantation, as well as the attendant ethical issues. Moreover, the use of the patient's own cells for the NTF cell therapy avoids the potential for graft rejection and the need for long-term administration of immunosuppressive anti-rejection agents.
"Pharmaceutical approaches to treating Parkinson's, ALS, and other neurodegenerative diseases have largely failed, as evidenced by the dearth of clinical candidates in pharma pipelines," said Prof. Jonathan Javitt of Johns Hopkins University, a BrainStorm board member and senior medical advisor to both Clinton and Bush administrations, "until the advent of patient-derived stem cell therapy, the safety risks associated with stem cell therapy were considered a major barrier to human therapy. The fact that human cells can be modified into therapeutically valuable cells and survive even when transplanted into an animal model suggests that those same cells may be even more valuable and viable when injected into the patient from whom they were derived."
“We at BrainStorm believe that this and previously published work in leading peer-reviewed Stem Cell and Neuroscience journals demonstrate the extraordinary promise of BrainStorm’s stem cell technology to alleviate the suffering of millions afflicted with neurodegenerative diseases. BrainStorm is planning with G-d’s help to start its preclinical safety trials for ALS this year to be followed immediately by Phase I Clinical trials for ALS to be conducted in Israel,” says Chaim Lebovits, BrainStorm’s President.
About BrainStorm Cell Therapeutics:
BrainStorm Cell Therapeutics Inc. is an emerging company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. The NurOwn(TM) patent pending technology is based on discoveries made by the scientific team led by Professor Eldad Melamed, Head of Neurology at Rabin Medical Center, and cell biologist Dr. Daniel Offen, Head of the Neuroscience Laboratory at the Felsenstein Medical Research Center of Tel-Aviv University. The technology allows for the differentiation of bone marrow-derived stem cells into functional neurons and astrocytes, as demonstrated in animal models. The Company holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The Company's initial focus is on Parkinson's, ALS and Spinal Cord Injury, although its technology has promise for treating several others diseases including MS, Huntington's disease and stroke.
Safe Harbor Statement
Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements, including BrainStorm's ability to complete its equity financing transactions previously disclosed. The potential risks and uncertainties include, among others, risks associated with BrainStorm Cell Therapeutics Inc.'s limited operating history, history of losses and expectation to incur losses for the foreseeable future; minimal working capital and difficulty raising additional capital, dependence on its license to Ramot's technology; ability, together with its licensor, to adequately protect the NurOwn(tm) technology; dependence on key executives and on its scientific consultants; ability to identify, negotiate and successfully implement strategic partnering relationships; ability to complete clinical trials successfully and to obtain required regulatory approvals; competition with companies, some of which have greater resources and experience in developing and obtaining regulatory approval for treatments in BrainStorm Cell Therapeutics Inc.'s market; the limited public trading market for BrainStorm Cell Therapeutics Inc.'s stock which may never develop into an active market; and other factors detailed in BrainStorm Cell Therapeutics Inc.'s annual report on Form 10-KSB, quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the Securities and Exchange Commission available at http://www.sec.gov/ or by request to the Company. The Company does not undertake any obligation to update forward-looking statements made by us.
BrainStorm Cell Therapeutics
Rami Efrati, CEO, +972-3-9236384 or
+972-54-4237074
efrati@brainstorm-cell.com