2022.9.13 UnicoCell has submitted an application to US FDA for a Phase III clinical trial of ELIXCYTE
UnicoCell has submitted an application on September 13th, 2022 to the Food and Drug Administration (FDA) of the US for a Phase III clinical trial of ELIXCYTE®, a new human allogeneic adipose-derived mesenchymal stem cell drug for the treatment of knee osteoarthritis.
The clinical phase II trial of ELIXCYTE® for knee osteoarthritis was completed in 2021. The results of the phase I/II trial have been published in Stem Cell Research & Therapy, 30 Oct 2021. The results showed that ELIXCYTE® for knee osteoarthritis treatment was effective, safe, and well-tolerated. The efficacy results were showed that ELIXCYTE® conferred the earlier onset of reductions in pain scores and improvements in functional scores than HA group.
Study for the Mechanism of Action of ELIXCYTE® on Osteoarthritis has been published in Cytotherapy, May 01 2022. Based on the pharmacological mechanisms of ELIXCYTE® obtained from pre-clinical studies, for osteoarthritis treatment, ELIXCYTE® show good immune regulation, anti-inflammatory properties, as well as the characteristics of promoting chondrocyte proliferation and protecting chondrocytes.
ELIXCYTE® is the only new cellular drug that has received national recognition, having been awarded the first gold medal in the drug category by the Ministry of Health and Welfare and the Ministry of Economic Affairs in 2021. In addition, UnicoCell has partnered with major hospitals in Taiwan to provide a regenerative medicine option for patients suffering from knee pain, and patients can now consult with Lin Kou Chang Gung Hospital and Jing Mei Hospital for autologous cell therapy.