Regeneus Limited regeneus.com.au Full Regeneus Limited profile here Regeneus Limited (ASX:RGS) is a regenerative medicine company that develops and commercialises proprietary technologies for the preparation of point-of-care and off-the-shelf cell therapies. Regeneus will fast-track clinical trials and approvals for its human off-the-shelf CryoShot cell therapy to treat osteoarthritis in Japan. Regenerative medicine company Regeneus' (ASX: RGS) will use Japans new laws to fast-track the clinical trial and potential approval of its new human off-the-shelf CryoShot cell therapy to treat osteoarthritis. The Japanese parliament has passed new laws that provide a rapid approval process specifically designed for human stem cell therapies. This provides a significant market opportunity for Regeneus to explore a new accelerated cell therapy approval process in Japan with limited safety and efficacy data. This will be achieved through a separate approval channel for regenerative medicine products that will allow the new cell therapy to be approved for commercial use once limited safety and efficacy data in humans has been demonstrated. Japan, the second largest healthcare market in the world, is setting itself up to be a world leader in regenerative medicine by providing a clear risk-adjusted regulatory framework for swift and safe translation of regenerative medicine research to … Continue reading →

New research has shown human neural stem cells could improve blood flow in critical limb ischemia through the growth of new vessels. Critical limb ischemia (CLI) is a disease that severely obstructs arteries and reduces the blood flow to legs and feet. CLI remains an unmet clinical problem and with an ageing population and the rise in type II diabetes, the incidence of CLI is expected to increase. The study, led by academics in the University of Bristol's School of Clinical Sciences, is published online in the American Heart Association journal Arteriosclerosis, Thrombosis, and Vascular Biology. Current stem cell therapy trials for the treatment of CLI have revitalised new hope for improving symptoms and prolonging life expectancy. However, there are limitations on the use of autologous cell therapy. The patient's own stem cells are generally invasively harvested from bone marrow or require purification from peripheral blood after cytokine stimulation. Other sources contain so few stem cells that ex vivo expansion through lengthy bespoke Good Manufacturing Practice processes is required. Ultimately, these approaches lead to cells of variable quality and potency that are affected by the patient's age and disease status and lead to inconsistent therapeutic outcomes. In order to circumvent … Continue reading →

The landmark trial could one day lead to a breakthrough in the treatment of spinal cord injuries. A patient with spinal cord injury will undergo an experimental therapy using embryonic stem cells for the first time. More participants, who are all severely injured, are expected in the Phase I trial. The ultimate goal is for the treatment to enable patients to eventually recover feeling and movement. Doctors have begun the first tests of human embryonic stem cells in patients, treating a man with spinal cord injuries in a landmark trial of the controversial process, the Geron Corporation said Monday. The patient began the pioneering treatment Friday with an injection of the biotech company's human embryonic stem cells, as part of a clinical trial that aims to test safety and efficacy toward regaining sensation and movement. The treatment took place at the Shepherd Center in Atlanta, Georgia, a spokeswoman for the hospital told AFP, declining to give further details due to patient privacy concerns. The Phase I trial is expected to involve around 10 patients. Participants in the human trials must be severely injured and start treatment with Geron's product, GRNOPC1, seven to 14 days after sustaining their injury. Patients will … Continue reading →