In Korea, Phase 1 clinical trial for MEDIPOST’s new product using second-generation stem cell culture technology will soon begin.
MEDIPOST announced on the 31st that it has received approval from the Ministry of Food and Drug Safety(MFDS) Korea for the Phase 1 clinical trial of the injectable cell therapeutic (code named SMUP-IA-01) for the treatment of knee osteoarthritis.
The SMUP-Cell platform technology which is applied to SMUP-IA-01, is the next-generation stem cell culture technology developed by MEDIPOST which can produce a therapeutically effective cell population based on size (SMall sized) and extra potency (Ultra Potent), hence named as ‘SMUP-Cell‘.
This Phase 1 clinical trial will be conducted in patients with mild and moderate knee osteoarthritis (K&L grade 2 to 3) and will evaluate the safety and potential efficacy of a single intra-articular dose.
The number of patients with knee osteoarthritis in Korea is estimated to be 2.87 million (as of 2018) by the Korea Health Insurance Review & Assessment Service and is increasing every year.
A MEDIPOST official explained, “this is the first step for the commercialization of SMUP-Cell technology based on research focused on cost reduction and higher therapeutic efficacy.”
The development of the SMUP-Cell technology and SMUP-IA-01 – an injectable therapeutic for osteoarthritis, has been supported by the “High-Tech Biopharmaceutical Global Technology Development Project” co-funded by the Ministry of Health and Welfare and the Ministry of Science and ICT.