Patient Enrollment Underway in Stem Cell Therapy Trial for Knee Cartilage Defects

MEDIPOST Inc. has treated the first U.S. participant in a trial evaluating its investigational mesenchymal stem cell (MSC) therapy for treating knee osteoarthritis-related cartilage defects. Dr. Justin Newman, with Orthopedic Centers of Colorado, performed the initial procedure.

“Treating the first participant in this trial is a milestone moment, not just for the science but for the osteoarthritis patients I see every day with pain and mobility challenges caused by cartilage defects,” Dr. Newman commented. “I look forward to learning more about the outcomes observed in those participating in this trial.”

The U.S. Food and Drug Administration has agreed the single pivotal study—supported by confirmatory evidence from prior Phase 3 trials in South Korea and Japan together with Korean real-world evidence— can serve as the basis for MEDIPOST’s planned U.S. BLA (Biologics License Application) filing. The milestone marks a significant step forward in MEDIPOST’s mission to bring a first-of-its-kind regenerative therapy to U.S. patients in the United States.

“Treating the first U.S. adult participant in this Phase III trial is a defining moment for the field of regenerative medicine,” stated Brian Cole, M.D., head of the Cartilage Research and Restoration Center at Rush University Medical Center. “This investigational MSC therapy is being studied for its role in knee osteoarthritis, where a gap exists between non-interventional palliative care and total knee replacement. This research gives us a meaningful opportunity to investigate whether a regenerative approach can help address it.”

Knee osteoarthritis affects more than 32 million adults. The Phase III trial is currently enrolling adults between the ages of 18-75 years with knee cartilage lesions and osteoarthritis. The study is designed to evaluate the clinical efficacy of the investigational MSC therapy and its potential benefits in adults with symptomatic cartilage defects due to knee osteoarthritis. Adults who believe they may qualify can visit ClinicalTrials.gov or speak with their physician about participation.

“Earlier clinical studies provided important data that helped guide the development of this Phase III trial,” stated Andreas Gomoll, attending orthopedic surgeon at the Hospital for Special Surgery (HSS) in New York. “This Phase III trial is designed to demonstrate the efficacy of an MSC therapy in adults with knee osteoarthritis; this is a significant step forward in generating the definitive evidence that could provide patients with better treatment options.”

MEDIPOST Inc. is a biotechnology company developing allogeneic, umbilical cord blood-derived stem cell therapies for inflammation-driven and degenerative diseases. The company is advancing a pipeline of regenerative medicine built on its proprietary stem cell technology platform with a focus on scalable, off-the-shelf therapeutic approaches.

Founded in 2000, MEDIPOST is a global cell therapy company whose integrated capabilities span discovery research, clinical development of allogeneic cell therapy assets, cord blood banking and contract development and manufacturing (CDMO). In 2012 the company commercialized CARTISTEM in South Korea, the world’s first approved allogeneic human umbilical cord blood-derived mesenchymal stem cell (hUCB-MSC) therapy for knee osteoarthritis. More than 36,000 patients have received CARTISTEM in South Korea since its launch.