▲Meridigen General Manager, Yogi Hsuan. (Picture by Reporter, Yao Hui Ru)

ETtoday/Yao Hui Ru (姚惠茹)

Today (June 5th), Meridigen (宣捷細胞生物製藥) announced that the U.S. Food and Drug Administration (USFDA) has approved UMC119-06 (New Mesenchymal Stem Cell drug) entry into clinical trial for ischemic stroke treatment. “The new drug market for ischemic stroke is huge. We will be cooperating with Shuang Ho Hospital (雙和醫院) and expect to finish enrolling 9 patients by next year Q1” said Yogi Hsuan (宣昶有).

Yogi Hsuan (宣昶有) indicated, following UMC119-01 (New Neonatal Bronchopulmonary Dysplasia Drug) clinical trial approval by both USFDA and TFDA, UMC119-06 clinical trial was also given the go-ahead by USFDA on May, this year, which is an extremely good news for Meridigen.

Yogi Hsuan (宣昶有) indicated, Meridigen’s R&D team had followed the guidelines specified in the “Introduction of Regulation Governing Specific Cellular Technology”, which demand R&D process to be conducted in a GTP (Good Tissue Practice), high standard and good quality environment. The team’s classic stroke animal model preliminary experiment results had been successful, providing proof that applying mesenchymal stem cell to rats with MCAo (Middle Cerebral Artery Occlusion) would provide restorative effect to the brain ischemic region.

▲Meridigen Team Members. (Picture by Reporter, Yao Hui Ru)

Yogi Hsuan (宣昶有) indicated, human umbilical cord mesenchymal stem cell had multiple unique characteristics, such as, promoting endogenous neuron activity, anti-apoptotic, angiogenesis, and immunomodulation, etc. Meridigen current development, a new drug for ischemic stroke had received the green light from USFDA and will be mainly administered intravenously to adults.  Expected to cooperate with Shuang Ho Hospital (雙和醫院) and anticipate to complete 9 cases by Q1, next year.

Meridigen Project Manager, Gili Su (蘇郁清) indicated, there are 15 million cases of stroke worldwide annually. Taiwan had 35000 stroke patients, where 75% were ischemic stroke, confirming a huge demand. Currently, there were 2 effective treatment methods, one is to deliver venous thrombolytic agent within 3 to 4.5 hours, and another method is by performing arterial thrombosis within 8 to 24 hours, though the risk of intracranial hemorrhage was relatively high, and then after 24 hours only supportive therapies could be applied to prevent recurrence. On the other hand, the new mesenchymal stem cell drug could extend the golden hour for ischemic stroke intervention time to 72 hours.

Gili Su (蘇郁清) indicated, USFDA review emphasize the importance of cell quality control, therefore Meridigen first procedure is by collecting donor’s umbilical cord and placenta from Cheng Kung University Hospital (國立成功大學醫學院附設醫院), which will be transported in a controlled temperature container to WuGu (五股) production plant and processed immediately within 24 hours.  Two screenings which consist of 8 viral and 18 bacteriophage detection items were done before procurement. Followed by, cell separation, purification and culture to ensure the cell was completely safe, and finally would be administered through intravenous drip infusion to maximize its effectiveness.

News Source：ETtoday 新聞雲, Picture by：ETtoday 新聞雲 Reporter Yao Hui Ru (姚惠茹)