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-Stem Cell Therapy by Mirae Cell Bio, a Jeju JNU Start-Up, Demonstrates Therapeutic Effect and Safety in Phase 1/2a Clinical Trial

Stem cell therapy developed by Mirae Cell Bio Co., Ltd., a start-up company founded at Jeju National University (JNU), has been confirmed to be both effective and safe in a phase 1/2a clinical trial.

In a world-first, Mirae Cell Bio successfully treated interstitial cystitis (IC)—a previously incurable disease—using stem cell therapy in a clinical trial jointly conducted with the Department of Urology at Asan Medical Center (Professor Park Joo-hyun). Mirae Cell Bio was established by JNU Professor Park Se-pil of the Department of Biomedical Information as an in-school venture.

The treatment, MR-MC-01, is an advanced biopharmaceutical product made using stem cells (MMSC) derived from healthy embryos. Both its therapeutic effects and safety were confirmed through the phase 1/2a trial.

The therapy has already been recognized with a New Excellent Technology (NET) certification by the Ministry of Health and Welfare of Korea in 2022 (NET No. 197), and was selected as the top achievement by the Korea Fund for Regenerative Medicine in 2024.

As MR-MC-01 has been designated as a rare drug in development (No. 30), it is eligible for conditional commercialization following the completion of the phase 2b clinical trial.

Professor Park Se-pil stated, “We will successfully complete the phase 2b trial—the final clinical stage—and aim to develop the world’s first cell therapy for urination disorders, as well as the first embryonic stem cell therapy to receive conditional product approval.”

In addition to interstitial cystitis, Mirae Cell Bio is also advancing clinical trials for treating urinary muscle weakness (low-activity bladder) associated with aging, using stem cell therapy.

The results of this study were published in the May issue of the global regenerative medicine journal Stem Cells Translational Medicine.