Nature Cell Eyes H2 Launch of U.S. Phase 2b Alzheimer's Trial

Nature Cell is preparing to initiate a Phase 2b clinical trial for Alzheimer’s disease in the United States.

On April 27, the company announced plans to proceed with an FDA-cleared study evaluating repeated intravenous administration of autologous adipose-derived stem cells as a potential disease-modifying therapy (DMT) for Alzheimer’s disease.

Although the investigational new drug (IND) application had previously been approved by the U.S. Food and Drug Administration, the trial had been temporarily delayed as the company prioritized development of its lead pipeline, JointStem. Nature Cell now plans to finalize its Phase 3 and accelerated approval strategy for JointStem through an FDA meeting scheduled for May 21, before advancing the Alzheimer’s program in parallel.

A revised protocol with minor updates to the original design will be submitted in June. Under U.S. regulations, the trial may proceed if no clinical hold is issued within 30 days. Patient enrollment is expected to begin in the second half of this year.

The study will enroll treatment-naïve patients at the mild cognitive impairment (MCI) stage. Participants will receive 10 intravenous infusions of autologous adipose-derived stem cells, with 200 million cells administered per dose. The protocol also includes pre-treatment with 500 mg of aspirin 2 to 4 hours prior to each infusion.

The trial aims to reconfirm safety while assessing cognitive improvement and the potential to slow or reverse disease progression. It builds on prior Phase 1/2a data that demonstrated safety and early efficacy signals using the same dosing regimen.

Nature Cell noted that it has accumulated experience from more than 45,000 intravenous stem cell administrations in Japan over the past decade across multiple indications, including Alzheimer’s disease.

In parallel, the company is pursuing entry into the global capital market, with plans to apply for a Nasdaq ADR listing between October and November 2026 and target completion in the first half of 2027.

Jeong-chan Ra, Chairman of Nature Cell, said, “This Phase 2b trial represents a critical step toward a potential paradigm shift in Alzheimer’s treatment,” adding that the company will accelerate both the JointStem and Alzheimer’s pipelines to strengthen global competitiveness and corporate value.