Regeneration Biomedical to Present Updated Phase 1 Trial Data on Autologous Stem Cell Therapy Injected Directly into the Brain for Alzheimer’s Disease in Podium Presentation at the ISCT 2025 Scientific Annual Meeting

• Abstract selected for a podium presentation and winner of the Host Region (US West) Award

• First-in-human data now includes five patients, with follow-up ranging from 23 weeks to over a year post-treatment

• Injections of Wnt-activated, autologous, expanded, adipose-derived stem cells (RB-ADSCs) delivered directly into the brain have shown no major adverse events from 23 to 55-week follow-up

• After a single injection, 80% of patients showed improvements in Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scores, normalization of p-Tau and decreased amyloid beta levels; 60% showed improvements Mini-Mental Status Examination (MMSE) scores

NEWPORT BEACH, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Regeneration Biomedical, Inc. (“RBI”), a clinical-stage company developing autologous stem cell therapies for neurodegenerative diseases, today announced that updated interim results from its ongoing Phase 1 clinical trial in Alzheimer’s disease (AD) will be featured in a podium presentation at the Scientific Annual Meeting of the International Society for Cell & Gene Therapy (ISCT) in New Orleans, taking place May 7-10, 2025.

In addition, the abstract was selected for a Host Region (US West) Award, which recognizes outstanding research and technological advancements around the world.

The oral presentation will be delivered by President and Founder of Regeneration Biomedical, Christopher Duma, M.D., F.A.C.S. and will highlight preliminary data from the first five patients in the Company’s ongoing Phase 1 trial evaluating Wnt-activated, autologous, expanded, adipose-derived stem cells (RB-ADSCs) in mild-to-moderate AD injected directly into the brain.

Results continue to show a reduction in proteins linked to AD progression, improvement in cognitive scoring, with the treatment demonstrating a favorable safety profile.

"We are honored to have our work recognized with the Host Region Abstract Award at this year’s ISCT Scientific Annual Meeting," said Dr. Duma. "This recognition, along with encouraging safety, tolerability and early signs of cognitive improvement observed in patients, reinforces the promise of our stem cell approach for AD. As we reach the one-year post-treatment milestone for some of our patients and approach full trial enrollment, we look forward to building on this momentum as we continue to advance our clinical program for AD. We are actively exploring next steps, including a Phase 2 trial and see potential opportunities to investigate this approach in other neurodegenerative diseases in the future, pending further data and regulatory guidance."

Gustavo Alva, M.D., principal investigator of the trial at Hoag Hospital, added, "AD remains one of the greatest unmet medical challenges, with current treatment options primarily targeting amyloid plaques, while leaving other critical issues unaddressed. Compared to current monoclonal antibody therapies, the results to date suggest that regenerative therapies like RB-ADSCs may offer a superior safety profile and a more comprehensive approach with meaningful benefits for patients living with this devastating disease."

Title: Interim Results of a "First-in-Human" Phase 1 Clinical Study of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous, Wnt-Activated, Adipose-Derived Stem Cells in Participants with Mild to Moderate Alzheimer's Disease
Date: May 8, 2025
Time: 8:00 – 9:00 am CT
Oral Session: Oral Abstract Session – Mesenchymal Stem/Stromal Cells #1
Oral Abstract ID: #3

Key interim findings observed in the first five patients from the first two cohorts at 12 weeks post-treatment include:

• CSF Biomarkers: 80% of patients showed a reduction in p-tau levels from a median of 60.2 pg/ml pre-injection (range: 46.9-76.1) to a median of 36.8 pg/ml (range: 15.0-66.6)
• Amyloid PET Imaging: Median centiloid scores decreased from 137.2 pre-injection (range: 53.33-155.47) to a median score of 100.53 (range: 55.58-168.1)
• Cognitive Scores:
  
  • MMSE scores: 60% of patients improved from a median score of 16 pre-injection (range: 14-19) to a median score of 18 (range: 12-20)
  • ADAS-Cog scores: 80% of patients improved from a median of 53 pre-injection (range: 40-69) to a median score of 38 (range: 20-69)

Safety and Tolerability:

• No immediate or delayed major adverse effects reported at least 23 weeks post-injection (range: 23-55 weeks)

About the Phase 1 Clinical Trial
This open-label, single-arm study is enrolling nine patients with mild-to-moderate Alzheimer’s disease, using a 3 + 3 single-dose escalation design to assess the safety of Wnt-activated, autologous, expanded, adipose-derived stem cells infused into the lateral ventricles of the brain. The study aims to determine a recommended dose for a potential Phase 2 trial. Secondary endpoints include Alzheimer’s disease clinical assessments, along with biochemical and anatomical biomarkers. Each participant will be followed for up to 12 months post-treatment. More details are available at ClinicalTrials.gov: NCT05667649.

About RB-ADSC Therapy
RB-ADSCs are highly purified, Wnt-activated adipose-derived stem cells obtained from a patient’s own adipose tissue. This first-in-class stem cell therapy is designed to stimulate the activation and maintenance of stem cells in regenerative regions of the brain while reducing inflammation, key factors in neurodegenerative diseases. Regeneration Biomedical’s innovative technique involves injecting RB- ADSCs directly into the brain, bypassing the blood-brain barrier to maximize activity. Following collection, the stem cells are cultured and expanded in vitro, selected for Wnt expression, a signaling protein that enhances stem cell communication, and reintroduced into the patient via an Ommaya reservoir, a device implanted under the scalp that provides direct access to the brain’s lateral ventricles.

About Regeneration Biomedical
Regeneration Biomedical, Inc. leverages world-class capabilities in stem cell therapy development and clinical application to develop autologous stem cell treatments for neurodegenerative diseases. Our proprietary therapy is derived from a patient’s own fat cells, which is a first-in-class Adipose-Derived Stem Cell (ADSC) population. We also employ a proprietary isolation-expansion-enrichment manufacturing protocol to synthesize the therapy to be able to inject it directly into the brain. For more information on Regeneration Biomedical, please visit www.regenerationbiomedical.com

Note on Forward-Looking Statements
Statements in this press release that are not historical in nature are forward-looking statements. These statements reflect the Company’s expectations based on currently available information, and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such forward-looking statements due to a variety of factors, including the risks inherent in the development of biopharmaceutical products such as ours. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement and Regeneration Biomedical, Inc. undertakes no obligation to revise or otherwise update this press release to reflect events or circumstances after the date hereof.

Company:
Robert Lynn, Chief Operating Officer
robert@regenerationbiomedical.com

Media:
Raena Mina, Ph.D.
rmina@burnsmc.com