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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Adipose-derived Stromal Vascular Fraction infusion | Experimental | Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF infusion) intravenous (IV) and Intranasal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposuction under local anesthesia | Procedure | Procedure will be performed via liposuction to harvest Adipose-derived stromal vascular fraction cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement in Mini Mental State Examination (MMSE) | Improvement in MMSE six months after therapy | Six months after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year after stem cell therapy |
| Clinical Improvement in Functional Activities Questionnaire (FAQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon McQuillan, MD | Ageless Regenerative Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ageless Regenerative Institute LLC | Aventura | Florida | 33180 | United States |
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|
| Infusion of AD-SVF via IV and Intranasal | Biological | IV and Intranasal Infusion of isolated AD-SVF |
|
| Three and six months after therapy |
| Clinical Improvement in Activities of Daily Living Questionnaire (ADL) | Three and six months after therapy |
| Clinical Improvement in Geriatric Depression Scale (GDS) | Three and six months after therapy |
| Clinical Improvement in Mini Mental State Examination (MMSE) | Three months after therapy |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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