Medipost Reaches Agreement with U.S. FDA for Single Phase 3 Trial of Cartistem

Patient Enrollment Reduced from 600 to 300, Clinical Trial Costs Cut by Up to 30%
Phase 3 Trial Completed in Japan, Approval Application Planned for Second Half of the Year

On June 4, Medipost announced that it had reached a final agreement with the U.S. Food and Drug Administration (FDA) to conduct the U.S. Phase 3 clinical trial of Cartistem, a treatment for knee osteoarthritis, as a single pivotal study.

Medipost company logo image. Medipost

Typically, more than two independent Phase 3 clinical trials are required to obtain new drug approval in the United States. However, Medipost explained that it was granted approval for a single clinical trial design based on domestic clinical results, long-term follow-up data, and real-world evidence (RWE).

According to the company, as a result of this agreement, the size of the U.S. Phase 3 clinical trial has been reduced from the original 600 patients to 300 patients. The clinical trial period is also expected to be shortened by approximately 3 to 6 months compared to previous estimates.

The company also expects clinical trial costs to decrease by about 20 to 30 percent compared to the original plan. However, the number of clinical trial sites will remain at 70 to accelerate patient enrollment. Cartistem, an osteoarthritis treatment using umbilical cord blood-derived mesenchymal stem cells, is already approved and sold in Korea.

Medipost has also completed a Phase 3 clinical trial for Cartistem in Japan and plans to apply for product approval in the second half of this year. The company aims to obtain approval in Japan by 2027.

Seungjin Lee, Head of Global Business at Medipost, said, "This is the result of the FDA recognizing the reliability of our clinical data and our clinical trial design," adding, "We will proceed with the U.S. clinical trial and global business development without delay."

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