Injecting stem cells from fat tissue into the brain for Alzheimer's disease
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
This study is testing whether injecting stem cells taken from fat tissue into the brains of people with mild to moderate Alzheimer's disease is safe and could help improve their condition.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Regeneration Biomedical, Inc. Industry-sponsored |
| Locations | 1 site (Newport Beach, California) |
| Trial ID | NCT05667649 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label safety study evaluates the use of autologous adipose-derived stem cells (RB-ADSC) injected directly into the brain of participants with mild to moderate Alzheimer's disease. The stem cells are harvested from the participant's own fat tissue and expanded outside the body before being reintroduced via an implanted reservoir in the scalp. The study aims to assess the safety of this treatment approach through a dose escalation method, with participants monitored for adverse events and preliminary efficacy over a 12-month period. A total of 9 participants will be enrolled, with evaluations including clinical assessments and imaging techniques.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 80 with a diagnosis of mild to moderate Alzheimer's disease and adequate cognitive function.
Not a fit: Patients with other neurological disorders or those who have had recent stem cell treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Alzheimer's disease who are not adequately addressed by current therapies.
How similar studies have performed: While this approach is novel, similar studies using stem cells for neurological conditions have shown promise, but this specific method is untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newport Beach, California
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.