The United States Patent and Trademark Office (USPTO) granted BrainStorm Cell Therapeutics Inc., a biotechnology company based in the United States and Israel, a Notice of Allowance for their newest patent. “We continue to protect our technology through strategic intellectual property achievements and this Notice of Allowance from the USPTO is a welcome addition to our IP portfolio,” announced CEO of BrainStorm, Chaim Lebovits (www.bizjournals.com). This patent application, “Isolated Cells and Populations Comprising Same for the Treatment of CNS Diseases,” Patent Publication No. US 20140154222, involves a cell therapy which utilizes mesenchymal stem cells (MSCs), found throughout the body, especially in the bone marrow and fat tissue, to treat neurodegenerative disorders such as Parkinson’s disease, ALS (amyotrophic lateral sclerosis), multiple sclerosis, and sciatic nerve injury (alsnewstoday.com).
BrainStorm owns NurOwn, the patented cell therapy technology which grows MCSs in proprietary laboratories to convert the MSCs into neurotrophic factors (NTFs). NTFs are vital components in the survival, differentiation, and growth of neurons in the body, even in conditions altered by neurodegenerative diseases (www.brainstorm-cell.com). MSCs also protect neurons from toxic damage (alsnewstoday.com). When precursor MSCs signal molecules, NTFs are secreted. The MSC-NTF cells produce numerous NTFs, such as Glial Derived Neurotrophic Factor (GDNF), Brain Derived Neurotrophic Factor (BDNF), Vascular Endothelial Growth Factor (VEGF), and Hepatocyte Growth Factor (HGF), which aid in the treatment of neurodegenerative diseases (www.brainstorm-cell.com). According to the patent application, BrainStorm claims that the new NurOwn patent will cover “[a] non-genetically modified isolated human cell which expresses CD90, expresses glial fibrillary acidic protein (GFAP) and secretes at least one neurotrophic factor, wherein a secretion of said neurotrophic factor is at least 2 times greater than a basal secretion of said neurotrophic factor in a non-differentiated mesenchymal stem cell.”
In the earlier stages of developing the technology covered in the patent application, BrainStorm formulated two clinical trials which improved patients’ respiratory capacity, muscle strength, and functional capacity (alsnewstoday.com). On their website, BrainStorm outlines the NurOwn production process, which evolved from the clinical trials. To begin, autologous bone marrow is extracted from the patient. BrainStorm ensures that the bone barrow aspiration process is routine, safe, brief, and conducted while the patient is under anesthesia at a hospital. The bone marrow is then sent to a NurOwn laboratory. After two to three weeks at the manufacturing facility where the MSCs are separated from the other cells in the bone marrow, the MSCs isolate and grow ex vivo into MSC-NTF cells. Thanks to the soon-to-be patented conditions, the cells are induced to produce higher levels of neurotrophic factors. When the MSC-NTFs are ready, BrainStorm collects the cells in syringes and sends them to the patient for administration (www.brainstorm-cell.com).
BrainStorm Cell Therapeutics Inc. engages in unprecedented adult stem cell therapies (www.bizjournals.com). NurOwn was developed by Professor Dani Offen and the late Professor Elad Melamed of Tel Aviv University, Israel’s largest university (Tel Aviv Unversity.com). Approximately 70 patients with ALS have received NurOwn in clinical trials performed in the United States and Israel (www.bizjournals.com), which has established NurOwn as safe and promising to those with neurodegenerative diseases (www.brainstorm-cell.com). BrainStorm claims to not use antibiotics or animal-derived products such as fetal calf serum (www.brainstorm-cell.com). According to BrainStorm’s website, the company has numerous manufacturing initiatives in process to make NurOwn more cost-effective and efficient.
The USPTO considers this patent pending until BrainStorm pays the necessary patent issue fees, and the final patent processes are completed.
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