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NCT05667649
RB-ADSC for Treatment of Mild to Moderate Alzheimer's Disease
Conditions: Alzheimer Disease
Sex: All
Ages: 45 Years – 80 Years
Phase: PHASE1
Enrollment: 18
Sponsor: Regeneration Biomedical, Inc.
Summary
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.
Eligibility Criteria
Inclusion Criteria:≥45 and ≤80 years of ageMild to moderate AD diagnosisAdequate cognitive functionNon-remarkable clinical laboratoryAbility to voluntarily provide written informed consentNo tumors or other disease responsible for dementiaWell-controlled comorbidities, on stable medications for 3 monthsThe participant is otherwise in good general healthThe participant must have a relative/caregiverParticipant must be able to donate adequate amount of lipoaspirate to establish the final productCaregiver separately meets the specified inclusion/exclusion criteria for caregiversExclusion Criteria: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 visitStem cell implantation of any type within 3 monthsExisting ventriculoperitoneal shuntsNeurological disorders except ADPsychiatric disorders including schizophrenia, bipolar/unipolar depressive disorder, deliriumDrug or alcohol abuse or dependence within the past 5 yearsParticipants with a history of cancer in the past 5 yearsNo caregiver available to meet the inclusion criteria for caregivers
Source: ClinicalTrials.gov (NCT05667649). StuddyBuddy aggregates publicly available trial information.