NatureCell Initiates FDA-Cleared Phase 2b Alzheimer’s Trial and Accelerates Clinical Development

Global Clinical Expansion Underway Ahead of Planned NASDAQ ADR Listing

LOS ANGELES, CA / ACCESS Newswire / April 28, 2026 / NatureCell Co., Ltd. (KOSDAQ: 007390) announced the planned reactivation and acceleration of its previously cleared Phase 2b clinical trial for Alzheimer’s disease under an Investigational New Drug (IND) authorization from the U.S. Food and Drug Administration (FDA).

The study is designed to evaluate autologous adipose-derived mesenchymal stem cells (AD-MSCs) administered via repeated intravenous infusions, as a potential disease-modifying therapy (DMT) for patients with early-stage Alzheimer’s disease.

The Phase 2b trial had previously received FDA IND clearance but was paused as the Company prioritized development of its lead asset, JointStem®. Following a scheduled FDA meeting on May 21, 2026, to finalize the Phase 3 and Accelerated Approval pathway for JointStem®, NatureCell plans to advance both programs in parallel.

An IND amendment incorporating minor protocol refinements is expected to be submitted in June 2026. In accordance with FDA regulations, the study may proceed if no Clinical Hold is issued within 30 days of submission. Trial initiation and patient enrollment are anticipated in the second half of 2026.

The Phase 2b study is designed to emphasize early intervention with the goal of modifying disease progression. The trial will enroll individuals with mild cognitive impairment (MCI) who have not initiated treatment for Alzheimer’s disease. Participants will receive autologous adipose-derived mesenchymal stem cells (AD-MSCs) administered intravenously across ten repeated infusions, with a dose of 200 million cells per infusion. In addition, 500 mg of oral aspirin will be administered 2 to 4 hours prior to each treatment. The primary objectives of the study are to evaluate safety, assess improvements in cognitive function, and determine the therapy’s potential as a disease-modifying treatment.

The primary objectives of the study are to confirm safety, evaluate improvements in cognitive function, and assess the therapy’s potential as a disease-modifying treatment.

The Phase 2b study is supported by both clinical and real-word evidence, building on prior Phase 1/2a clinical data that demonstrated safety and early signals of efficacy using the same administration regimen. In addition, stem cell technologies developed by Biostar Stem Cell Research Institute have been applied in Japan for more than a decade under regenerative medicine frameworks. This includes over 45,000 intravenous administrations across multiple indications, including neurodegenerative diseases, supporting both feasibility and safety of the approach.

The advancement of NatureCell’s clinical programs aligns with its broader global capital markets strategy. The Company plans to file for a NASDAQ ADR listing between October and November 2026, targeting completion in the first half of 2027.

By advancing both Jointstem® and its Alzheimer’s pipeline, NatureCell aims to present a differentiated investment profile that combines a near-term commercial-stage asset with a high-impact CNS pipeline focused on disease modification, supported by a platform validated through real-world clinical experience.

Dr. Jeong Chan Ra, Chairman of NatureCell Co., Ltd., commented, “This Phase 2b trial represents a critical step toward fundamentally changing the treatment paradigm for Alzheimer’s disease. By advancing both our JointStem® program and Alzheimer’s pipeline in parallel, we are strengthening our global competitiveness and positioning NatureCell for long-term value creation.”

About NatureCell: NatureCell Co., Ltd. is a biotechnology company focused on the development and commercialization of stem cell-based regenerative therapies for degenerative and intractable diseases.

This press release contains forward-looking statements regarding future plans, expectations, and projections. These statements are subject to risks and uncertainties that may cause actual results to differ materially.

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SOURCE: NatureCell

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