Regeneration Biomedical to Present Data on First Two Subjects in a Phase I Clinical Trial of Stem Cell Therapy delivered directly into the brains of Patients with Alzheimer’s Disease
28 Julio 2024 - 7:05AM
Regeneration Biomedical, Inc. (“RBI”), a clinical-stage company
developing autologous stem cell treatments for neurodegenerative
diseases, today announced a presentation on early data on the first
two subjects from a Phase 1 clinical trial of Wnt-activated,
autologous, expanded, adipose-derived stem cells (RB-ADSCs)
administered directly into lateral ventricles of the brain in
patients with Alzheimer’s Disease (AD). The data will be presented
at the Alzheimer’s Association International Conference (AAIC) in
Philadelphia at 8 a.m. EDT, July 28, 2024.
“There has been significant investment to find an effective
treatment for AD,” said Christopher Duma, M.D., F.A.C.S.,
president, founder of RBI and presenter of the data. “However,
recently approved anti-beta amyloid antibodies only slightly reduce
the rate of cognitive decline at the risk of significant side
effects. We are taking a very different approach using
adipose-derived stem cells infused directly into the lateral
ventricles to bypass the blood brain barrier (BBB). In vivo studies
demonstrated that stem cells injected in this fashion do locate
into the ventricles and parenchyma. In addition, an IRB-approved
pilot study of an earlier version of our stem cell product in
patients with advanced neurodegenerative diseases generated
promising results. We are presenting early results from this single
ascending dose, first-in-human Phase 1 trial. Though the first two
patients were treated at the lowest dose based on the protocol, we
have seen intriguing results on AD biomarkers, which we will share
during our presentation.”
Title: |
Intracerebroventricular injection of autologous, Wnt-activated,
adipose-derived stem cells for the treatment of Alzheimer’s
Disease: Experience with the first two patients of a “First in
Human” Phase 1 FDA trial |
Session: |
Developing Topics: Drug Development |
Poster #: |
94645 |
Time: |
8 a.m. to 4:15 p.m. EDT |
Date: |
July 28, 2024 |
Room: |
Exhibit Hall (Hall BC) |
This FDA-cleared, Phase 1 open-label, single-arm study will
enroll nine subjects over approximately one year randomized into a
3 + 3 dose escalation design to evaluate the safety of autologous
RB-ADSC infused into the lateral ventricles of the brain in
subjects with mild-to-moderate AD, and to determine a recommended
dose for a potential Phase 2 clinical trial. Secondary endpoints
include AD clinical assessments and biochemical and anatomical
biomarkers. Each participant will be followed for up to 12 months
after treatment. More information on the clinical trial can be
found at NCT05667649.
RB-ADSC are Wnt-activated adipose-derived stem cells obtained
from a patient’s own adipose tissue. After collection, the stem
cells are cultured and expanded in vitro, selected for Wnt
expression, which is a signaling protein known to stimulate stem
cells to communicate with other stem cells, and then reintroduced
into the same patient via an Ommaya reservoir implanted under the
scalp, which has direct access to one of the lateral ventricles
located in the brain. Research in two animal models has
demonstrated that stem cells infused into the ventricular system
distribute themselves into brain parenchyma. In addition, no
inflammation, obstruction of cerebral spinal fluid circulation or
other safety signals were observed.
About Regeneration BiomedicalRegeneration
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 and inject it directly into the brain. For more
information on Regeneration Biomedical, please visit
www.regenerationbiomedical.com.
Company:Robert Lynn, Chief Operating
Officerrobert@regenerationbiomedical.com
Media:Robert Flamm, Ph.D.rflamm@burnsmc.com