UnicoCell Biomed Co., Ltd. ("UnicoCell") has completed recruiting patients for phase II clinical trial of chronic kidney disease with ELIXCYTE®, an allogeneic adipose-derived mesenchymal stem cell drug. Unblinding result will be released after one-year follow-up for the efficacy of ELIXCYTE®. This clinical trial for chronic kidney disease is the first clinical trial approved by both the U.S. Food and Drug Administration (FDA) and the Taiwan Food and Drug Administration (TFDA).
ELIXCYTE®, a new stem cell drug, was awarded a gold medal in the pharmaceutical category of the Pharmaceutical Technology Research and Development Award by the Ministry of Health and Welfare and the Ministry of Economic Affairs in 2021, the only new stem cell drug to receive national recognition. Renal deterioration is often irreversible and requires dialysis or kidney transplantation when it progresses to late-stage renal failure. Dialysis significantly reduces a patient's quality of life and other physiological functions, while a kidney transplant requires waiting for a suitable donor and lifelong medication for side effects such as transplant rejection. The global market for chronic kidney disease drugs is estimated at US$15.7 billion. Taiwan's outpatient dialysis incidence rate rose from 331 per million people in 2000 to 523 per million people in 2018, and the incidence rate of dialysis for people over 75 years of age continues to rise; the dialysis prevalence rate increased from 1,449 per million people in 2000 to 3,587 per million population in 2018, according to 2020 Taiwan Kidney Disease Annual Report published by the Ministry of Health and Welfare. The prevalence of chronic kidney disease in Taiwan is increasing year by year and lead to the result of heavy medical burden to individuals and the country. The overall medical expenses reached NT$ 56.2 billion in 2020, with 84% of expenses spent on outpatient dialysis treatment (Source: Ministry of Health and Welfare, Health Insurance Cloud System to protect kidney patients and strengthen the three layers of drug safety protection).
Regenerative medicine offers new treatment possibilities for diseases caused by irreversible damage to organs or tissues. UnicoCell’s goal is to provide patients with an alternative opportunity to pursue a better quality of life by targeting degenerative or irreversible diseases. In addition to the current clinical trial for chronic kidney disease, the company has also completed a Phase II clinical trial for the treatment of knee osteoarthritis and are planning a later phase clinical trial. The company's laboratory with build-in high quality system has been certified by government and domestic/international accreditation agents, and the PIC/S GMP complied facility has been built with the plan of being certified as a cellular pharmaceutical manufacturer in the near future.