A Phase 1/2 interventional study of Liposuction under local anesthesia and Infusion of AD-SVF via IV and Intranasal in Alzheimer's Disease, sponsored by Ageless Regenerative Institute. Withdrawn at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-11-24.
Sponsored by Ageless Regenerative Institute · Phase 1/2, Interventional, and Treatment
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with Alzheimer's Disease and clinical outcomes?
Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF) will be infused intra-venous and Intra nasal. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.
Exclusion Criteria:
Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF infusion) intravenous (IV) and Intranasal.
Procedure: Liposuction under local anesthesia · Biological: Infusion of AD-SVF via IV and Intranasal
Procedure will be performed via liposuction to harvest Adipose-derived stromal vascular fraction cells.
Also known as: Lipoaspiration, Adipose tissue harvesting
IV and Intranasal Infusion of isolated AD-SVF
Clinical Improvement in Mini Mental State Examination (MMSE)
Improvement in MMSE six months after therapy
Time frame: Six months after therapy
Adverse Event
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 12-months period following treatment.
Time frame: One year after stem cell therapy
Clinical Improvement in Functional Activities Questionnaire (FAQ)
Time frame: Three and six months after therapy
Clinical Improvement in Activities of Daily Living Questionnaire (ADL)
Time frame: Three and six months after therapy
Clinical Improvement in Geriatric Depression Scale (GDS)
Time frame: Three and six months after therapy
Clinical Improvement in Mini Mental State Examination (MMSE)
Time frame: Three months after therapy
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Ageless Regenerative Institute