Regeneration Biomedical Presents Data on First Cohort from an Ongoing Phase I Clinical Trial of Stem Cell Therapy Delivered Directly into the Brains of Patients with Alzheimer’s Disease
Wnt-activated, autologous, expanded, adipose-derived stem cells (RB-ADSCs) administered directly into lateral ventricles of the brain were well tolerated and reduced levels of p-Tau and amyloid-beta at 12 weeks
Mini-Mental State Examination (MMSE) scores improved in two of three subjects
Data presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid, 3 to 5 p.m. CET, October 29 and 30, 2024
NEWPORT BEACH, CA, USA I October 29, 2024 I Regeneration Biomedical, Inc. (“RBI”), a clinical-stage company developing autologous stem cell treatments for neurodegenerative diseases, today announced a presentation on the first dose cohort 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 treatment was well tolerated. At 12 weeks, the levels of p-Tau and beta amyloid were reduced. Results of the Mini-Mental State Examination (MMSE) trended toward improved cognition in two of three subjects. The data were presented at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid from 3 to 5 p.m. CET, October 29 and 30, 2024.
“Results from the first dose cohort increase our confidence in the safety of our RB-ADSC product candidate in Alzheimer’s disease patients,” said Christopher Duma, M.D., F.A.C.S., president, founder of RBI and presenter of the data. “In addition, improvements in Alzheimer’s disease biomarkers and an improving trend in a cognitive measure at up to 12 weeks are consistent with our hypothesis that infusion of Wnt-activated stem cells into the brain may initiate a cessation or reversal of at least some of the pathological processes underlying this devastating disease. We have completed enrollment of our second dose cohort and we are progressing enrollment with our third and final dose cohort. We look forward to presenting the full data set at future medical conferences.”
The Phase 1 open-label, single-arm study is enrolling nine subjects over approximately one year randomized into a 3 + 3 single 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 52 months after treatment. More information on the clinical trial can be found at NCT05667649.
RB-ADSCs 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 the lateral ventricles located in the brain.
The treatment, including the liposuction procedure to obtain adipose-derived stem cells, was well tolerated with reported minor adverse events including minor bruising and discomfort post-liposuction and mild incisional pain following Ommaya reservoir implantation. The injection process, which required an average of eight minutes to perform without anesthetic, was well tolerated with no reported adverse events for at least 11 weeks post injection, including headache or nausea. CSF analysis in all three patients at 12 weeks showed a decrease in p-Tau from a median of 60.2 pg/ml (range: 59.2-76.1) to a median of 36.8 (range 27.3-46.2, normal). Pre-injection amyloid PET scan centiloid median score was reduced from 138.5 (range 54.2-155.5 to a median of 100.5 (range 55.6-104.0) at 12 weeks. MMSE scores improved by week 12 from a pre-injection median of 17 (range: 16-18) to a median of 19.5 (range: 19-20) in two and three evaluable patients.
Title:
Intracerebroventricular injection of autologous adipose-derived stem cells for the treatment of Alzheimer’s Disease: Experience with the first of three 3-patient cohorts in a “First in Human” Phase 1 FDA trial
Session:
Session 1: Late Breaking Abstracts
Poster #:
LP019
Time/Date:
3 p.m. CET, October 29, to 5 p.m. CET, October 30
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 and inject it directly into the brain. For more information on Regeneration Biomedical, please visit www.regenerationbiomedical.com.
Wnt-activated, autologous, expanded, adipose-derived stem cells (RB-ADSCs) administered directly into lateral ventricles of the brain were well tolerated and reduced levels of p-Tau and amyloid-beta at 12 weeks
Mini-Mental State Examination (MMSE) scores improved in two of three subjects
Data presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid, 3 to 5 p.m. CET, October 29 and 30, 2024
NEWPORT BEACH, CA, USA I October 29, 2024 I Regeneration Biomedical, Inc. (“RBI”), a clinical-stage company developing autologous stem cell treatments for neurodegenerative diseases, today announced a presentation on the first dose cohort 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 treatment was well tolerated. At 12 weeks, the levels of p-Tau and beta amyloid were reduced. Results of the Mini-Mental State Examination (MMSE) trended toward improved cognition in two of three subjects. The data were presented at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid from 3 to 5 p.m. CET, October 29 and 30, 2024.
“Results from the first dose cohort increase our confidence in the safety of our RB-ADSC product candidate in Alzheimer’s disease patients,” said Christopher Duma, M.D., F.A.C.S., president, founder of RBI and presenter of the data. “In addition, improvements in Alzheimer’s disease biomarkers and an improving trend in a cognitive measure at up to 12 weeks are consistent with our hypothesis that infusion of Wnt-activated stem cells into the brain may initiate a cessation or reversal of at least some of the pathological processes underlying this devastating disease. We have completed enrollment of our second dose cohort and we are progressing enrollment with our third and final dose cohort. We look forward to presenting the full data set at future medical conferences.”
The Phase 1 open-label, single-arm study is enrolling nine subjects over approximately one year randomized into a 3 + 3 single 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 52 months after treatment. More information on the clinical trial can be found at NCT05667649.
RB-ADSCs 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 the lateral ventricles located in the brain.
The treatment, including the liposuction procedure to obtain adipose-derived stem cells, was well tolerated with reported minor adverse events including minor bruising and discomfort post-liposuction and mild incisional pain following Ommaya reservoir implantation. The injection process, which required an average of eight minutes to perform without anesthetic, was well tolerated with no reported adverse events for at least 11 weeks post injection, including headache or nausea. CSF analysis in all three patients at 12 weeks showed a decrease in p-Tau from a median of 60.2 pg/ml (range: 59.2-76.1) to a median of 36.8 (range 27.3-46.2, normal). Pre-injection amyloid PET scan centiloid median score was reduced from 138.5 (range 54.2-155.5 to a median of 100.5 (range 55.6-104.0) at 12 weeks. MMSE scores improved by week 12 from a pre-injection median of 17 (range: 16-18) to a median of 19.5 (range: 19-20) in two and three evaluable patients.
Title:
Intracerebroventricular injection of autologous adipose-derived stem cells for the treatment of Alzheimer’s Disease: Experience with the first of three 3-patient cohorts in a “First in Human” Phase 1 FDA trial
Session:
Session 1: Late Breaking Abstracts
Poster #:
LP019
Time/Date:
3 p.m. CET, October 29, to 5 p.m. CET, October 30
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 and inject it directly into the brain. For more information on Regeneration Biomedical, please visit www.regenerationbiomedical.com.
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