RECRUITING

Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease

Conditions

Alzheimer Disease Alzheimer's Disease AD Autologous Stem cells

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a research study to evaluate the safety of an investigational autologous cell product obtained from participant's own adipose tissue as a possible treatment for Alzheimer disease.

Official Title

Ph 1, Open-Label Safety Study of Escalating Doses of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous ADSCs in Participants With Mild-Moderate AD Whose Treatment is Not Addressed Adequately by Available Therapy

Quick Facts

Study Start:2023-08-14

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05667649

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ≥45 and ≤80 years of age * Mild to moderate AD diagnosis * Adequate cognitive function * Non-remarkable clinical laboratory * Ability to voluntarily provide written informed consent * No tumors or other disease responsible for dementia * Well-controlled comorbidities, on stable medications for 3 months * The participant is otherwise in good general health * The participant must have a relative/caregiver * Participant must be able to donate adequate amount of lipoaspirate to establish the final product * Caregiver separately meets the specified inclusion/exclusion criteria for caregivers	* Taking other medications for AD, except that donepezil memantine, AChEIs including patches, Vitamin E, fish oil, and/or gingko biloba are allowed if doses have been stable for at least 3 months prior to the Screening visit * Stem cell implantation of any type within 3 months * Existing ventriculoperitoneal shunts * Neurological disorders except AD * Psychiatric disorders including schizophrenia, bipolar/unipolar depressive disorder, delirium * Drug or alcohol abuse or dependence within the past 5 years * Participants with a history of cancer in the past 5 years * No caregiver available to meet the inclusion criteria for caregivers

Inclusion Criteria

Exclusion Criteria

* ≥45 and ≤80 years of age
* Mild to moderate AD diagnosis
* Adequate cognitive function
* Non-remarkable clinical laboratory
* Ability to voluntarily provide written informed consent
* No tumors or other disease responsible for dementia
* Well-controlled comorbidities, on stable medications for 3 months
* The participant is otherwise in good general health
* The participant must have a relative/caregiver
* Participant must be able to donate adequate amount of lipoaspirate to establish the final product
* Caregiver separately meets the specified inclusion/exclusion criteria for caregivers

* Taking other medications for AD, except that donepezil memantine, AChEIs including patches, Vitamin E, fish oil, and/or gingko biloba are allowed if doses have been stable for at least 3 months prior to the Screening visit
* Stem cell implantation of any type within 3 months
* Existing ventriculoperitoneal shunts
* Neurological disorders except AD
* Psychiatric disorders including schizophrenia, bipolar/unipolar depressive disorder, delirium
* Drug or alcohol abuse or dependence within the past 5 years
* Participants with a history of cancer in the past 5 years
* No caregiver available to meet the inclusion criteria for caregivers

Contacts and Locations

Study Locations (Sites)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

United States

Collaborators and Investigators

Sponsor: Regeneration Biomedical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-14

Study Completion Date2025-03

Study Record Updates

Study Start Date2023-08-14

Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

Alzheimer's Disease
AD
Autologous
Stem cells

Additional Relevant MeSH Terms

Alzheimer Disease