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?
Procedure: Liposuction under local anesthesia
Biological: Infusion of AD-SVF via IV and Intranasal
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02912169
Ages eligible for Study
55 Years to 85 Years
Genders eligible for Study
Accepts Healthy Volunteers
Males or females, age 55 or older
Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
Up to date on all age and gender appropriate cancer screening per American Cancer Society (Refer to section 9.3 for more details).
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Life expectancy < 6 months due to concomitant illnesses.
Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
Active infectious disease. For patients who have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis ,then an expert will be consulted as to patient eligibility based on the patient's infectious status
Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
Patients on chronic immunosuppressive transplant therapy
Systolic blood pressure (supine) ≤90 mmHg;
Resting heart rate > 100 bpm;
Active clinical infection.
Cerebrovascular accident within 6 months prior to study entry
Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Patient or legal guardian if applicable us unwilling and/or not able to give written informed consent.
Dementia due to any condition other than AD, including vascular dementia
All locations for NCT02912169
United States (1)
Ageless Regenerative Institute LLC
Aventura, Florida, United States, 33180
View full eligibility
Tris trial is registered with FDA with number: NCT02912169. The sponsor of the trial is Ageless Regenerative Institute and it is looking for 0 volunteers for the current phase.
Official trial title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Vascular Fraction (AD-SVF) Cells Delivered Intravenous (IV) and Intranasal in Patients With Alzheimer's Disease
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