SEOUL -- Medipost, a South Korean biotech firm know for stem cell-based treatment, has applied for state approval to go ahead with phase 2 clinical trials to evaluate the safety and efficacy of its next-generation intra-articular Injectable treatment and prevention of knee osteoarthritis, code-named "SMUP-IA-01"
Medipost's SMUP-Cell platform technology for developing next-generation cell therapy products enables the selection of small-sized highly-efficient stem cells and mass-culture under specific environments and conditions which enhance stem cell properties and functionality. Cartistem, a stem cell-based treatment of damaged cartilage, won state approval for sales in South Korea in 2012.
Cartistem and SMUP-IA-01 are both knee osteoarthritis treatments and are applied step by step depending on the patient's symptoms. Medipost said that cartistem can be applied to patients requiring surgery, while SMUP-IA-01 is primarily applied to patients requiring no surgery and expands the opportunity for regenerative medicine for patients with "high unmet medical needs."
Medipost said it has been approved by the Korea Food and Drug Administration to conduct the second-stage clinical trial of SMUP-IA-01 that would be injected in the knee joint cavity of 90 patients with mild and moderate knee osteoarthritis into three groups -- low dose, medium dose and placebo. Medipost would observe them for one year to see if it is safe and improves clinical symptoms before carrying out phase 3 clinical trials.
Based on safety and validity data confirmed through clinical trials in South Korea, Medipost would send a pre-IND (investigational new drug) application to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year.
In results of phase 1 clinical trials, released in March, Medipost said SMUP-IA-01 showed excellent safety and improved knee pain and joint function after six months of evaluation. As many pharmaceutical companies face difficulties in developing fundamental treatments, regenerative medicine, including stem cell treatments, is emerging as a new strategy.
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