The United States Patent and Trademark Office (USPTO) has recently granted US Patent No. 9080184 entitled “Transgenic Therapeutic Stem Cells and Methods for Their Use and Manufacture” to Stemedica Cell Technologies Inc., a leading manufacturer of adult, allogeneic stem cells and stem cell factors.
Invented by Drs Alex Kharazi, (Stemedica’s chief technology officer), MG Muralidhar (tesearch scientist), and Grigory Vertelov (research scientist), this patent covers human mesenchymal stem cells genetically modified to produce an extra amount of human granulocyte-colony-stimulating factor (hG-CSF). hG-CSF is known to have multiple physiological effects such as neuroprotection; induction of neurogenesis (the process by which neurons are generated from the neural stem cells and progenitor cells); stimulation of production of anti-inflammatory compounds; stem cell mobilisation; and inhibition of apoptosis (programmed cell death). All of these therapeutic effects hold great promise for medical conditions such as inflammatory diseases, ischemic stroke and heart attack. Stemedica’s preclinical in vivo studies confirmed these therapeutic effects in an animal model.
“Using hG-CSF-transduced MSC will allow Stemedica and other users the opportunity to enhance the potency of our product via the increased secretion of this cytokine, which may improve clinical trial results,” said Alex Kharazi, MD, PhD, chief technology officer of Stemedica. “This newly-patented technology now allows Stemedica to use mesenchymal stem cells as a delivery vehicle for hG-CSF directly to the site of injury. This treatment approach should reduce the side effects of hG-CSF following its systemic administration.”
This product, genetically-engineered human mesenchymal stem cells, is, in essence, a second generation of Stemedica’s current human MSC (hMSC). Plans for this product include safety testing and regulatory interaction with the FDA. Any other company or research institution interested in approaching an application with hMSCs modified with hG-CSF gene covered by the patent is invited to contact Stemedica.
“This is a new generation of stem cells for unique therapies in the field of regenerative medicine. The cells have been genetically modified to make and deliver therapeutic, non-toxic proteins to targeted cells or organs in larger quantities than stem cells currently used in regenerative medicine,” said Nikolai Tankovich, MD, PhD, FASLMS, president and chief medical officer of Stemedica. “As of today, our in vivo safety tests are in a pre-clinical stage to satisfy the standards required by the FDA for human clinical trials.”