![]() We have ways to maneuver stem cells to the destination and target tissue we want. “We see the cells like clay in our hands that we manipulate in culture and mimic development processes. “Any tissue in the body can be made from the stem cells as they are immature, very easy to work with cells and can proliferate as much as we want to become whatever we want,” says Molakandov. After developing treatments for multiple sclerosis, he turned his focus to two main disease areas – diabetes and ALS. ![]() You have to calculate everything from how much you eat, the amount of insulin to inject, and how much physical exercise to take – everything has to be managed! With our therapy, we aim to make it easy by simply putting the functional cells in the patient,” Molakandov tells pharmaphorum.įounded in 2009 by Kadimastem’s chief scientist Professor Michel Revel, the therapy is based on stem cell research from Israel’s Weizmann Institute of Science, looking at the potential of restoring activity lost in tissues due to disease damage. “Diabetes is a very hard disease to manage, especially with young children. Using micro-encapsulation technology, integrated within IsletRx, the islet cells are protected from attack by the host immune system. The product in development, IsletRx, is clinical grade pancreatic islet cells which produce and secrete insulin and glucagon in response to blood glucose levels. The Tel-Aviv listed company is leading research and development of a cell therapy comprising functional pancreatic islet cells. Every donor is different, and if you offer a therapy, it should be good, reliable, consistent, and the same for everyone.”Īs the head of diabetes research at Israeli cell therapy company Kadimastem, Molakandov believes they could have the next major diabetes therapy. “But even if there were enough donor islets, the standardisation of this therapy is horrible. “Only a few thousand people have benefited from this therapy as there are not enough donors,” says Kfir Molakandov. ![]() But years later, the potential of islet therapy is yet to be realised due to difficulties finding donors and harvesting cells. In the 1990s, when the first transplant of islets took place, it was hailed as the cure for diabetes. Catherine Longworth spoke with Kadimastem’s head of diabetes research, Kfir Molakandov to find out more. As the 3 coPIs of the phase 3 study of NurOwn, we support continued discussions with the FDA on the best path forward.Israeli company Kadimastem is developing regenerative medicine therapies based on differentiated cells derived from human embryonic stem cells to treat diseases such as Amyotrophic lateral sclerosis (ALS) and diabetes. Understanding whether there are people with ALS who might respond better to NurOwn is important given the unmet therapeutic need. Healey & AMG Center for ALS at Massachusetts General Hospital jointly stated, "While the prespecified primary outcome measure was not met, there were participants with beneficial clinical effects and overall changes in relevant biomarkers of drug effect. Merit Cudkowicz, chief of Neurology at Massachusetts General Hospital, Julieanne Dorn professor of Neurology at Harvard Medical School, director of the Sean M. Robert Brown, director of the Program in Neurotherapeutics at the University of Massachusetts Medical School, Dr. The difference between stem-cell treatment and placebo did not reach statistical significance because of the high response rate seen with placebo.ĭr. Disease progression was measured by the rate of change in scores on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R). In the phase 3 clinical trial ( NCT03280056), participants with ALS (n=189) treated with placebo or MSC-NTF had a 1.25 point reduction in disease progression (P=.453). "We continue to believe that NurOwn's phase 3 trial represents a significant contribution to ALS therapy and will continue to work tirelessly to address the needs of people living with ALS by advancing science and partnering with researchers around the world." The company intends to request a Type A meeting and looks forward to continued discussions with the FDA," said Chaim Lebovits, chief executive officer of BrainStorm. "While we are disappointed that the FDA has not accepted our BLA for NurOwn in ALS, we remain committed to NurOwn's advancement as a treatment for this devastating disease. The company may request a Type A meeting to discuss the content of the refusal to file letter per the FDA. The Food and Drug Administration (FDA) has issued a refusal to file letter for the Biologics License Application (BLA) for autologous neurotrophic factor-secreting mesenchymal stem cells (MSC-NTF)(NurOwn BrainStorm Cell Therapeutics, New York, NY) as treatment of amyotrophic lateral sclerosis (ALS).
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