· In patients with mild to moderate knee osteoarthritis, a single injection of SMUP-IA-01 into the joint cavity resulted in clinical improvement in joint function and reduced pain and stiffness
· MEDIPOST plans to confirm the potential for improving the structure and function of the knee and regeneration of damaged cartilage tissues through the next phase clinical trial in the second half of this year and long-term follow-up observations
MEDIPOST reported on the 22nd the results of a phase 1 clinical trial in Korea of its injectable drug for knee osteoarthritis (SMUP-IA-01) developed with SMUP-Cell, the next-generation high-efficiency stem cell culture platform.
The phase 1 clinical trial in Korea of the high-efficiency allogeneic stem cell treatment SMUP-IA-01 was conducted on patients with mild to moderate knee osteoarthritis (K&L Grade 2–3) at Seoul National University Hospital. Twelve patients were given a single injection into their knee joint cavity, and the safety and exploratory efficacy were evaluated for 6 months.
Patients were divided into three groups by dose, and SMUP-IA-01 was injected once in their knee joint cavity. The results of safety evaluation showed no serious adverse events (SAE), including death or serious adverse drug reactions (SADR).
In the efficacy evaluation, in all groups, compared to the baseline before drug administration, the WOMAC total score change for knee pain, stiffness, and function at 6 months after administration was -15.33±5.77, and the subjective pain evaluation (100-mm VAS) change and subjective knee function evaluation (IKDC score) change were -39.67±10.00 and 19.17±5.12 respectively. Overall, it showed improvements in pain and function with no significant difference between the dose groups.
An officer of MEDIPOST said, “SMUP-IA-01 is a product developed for patients with mild to moderate knee osteoarthritis (K&L Grade 2–3), which account for 65% of all knee osteoarthritis patients, who do not require surgery and are using symptomatic therapy such as pain relievers and hyaluronic acid. A single injection can relieve knee pain and improve clinical symptoms and joint function,” and added, “We also plan to confirm the potential for improving the structure and function of the knee joint and regeneration of damaged cartilage tissues through the next phase clinical trial, which will include long-term follow-up observations, in the second half of this year.”
MEDIPOST’s SMUP-Cell technology, developed to overcome the limitations in the production and commercialization of first-generation stem cell therapy, is a next-generation “high-efficiency and low-cost” cell culture platform technology that enables the selection and mass-production of high-efficiency cells. The final formulation of our stem cell treatment developed with the SMUP-Cell platform can be stored and transported under normal refrigeration, which makes it more suitable for global business with an extended shelf life and reduced transportation costs as well as higher economic efficiency and commercial viability.