NCT05667649 Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease
| NCT ID | NCT05667649 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Regeneration Biomedical, Inc. |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2023-08-14 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2023-08-14 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 Exclusion 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 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
Frequently Asked Questions
Who can join the NCT05667649 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05667649 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05667649 currently recruiting?
Yes, NCT05667649 is actively recruiting participants. Visit ClinicalTrials.gov or contact Regeneration Biomedical, Inc. to inquire about joining.
Where is the NCT05667649 trial being conducted?
This trial is being conducted at Newport Beach, United States.
Who is sponsoring the NCT05667649 clinical trial?
NCT05667649 is sponsored by Regeneration Biomedical, Inc.. The trial plans to enroll 18 participants.
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