Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Alzheimer's Disease

Phase 1

Withdrawn

• Conditions: Alzheimer's Disease
• Interventions: Procedure: Liposuction under local anesthesia; Biological: Infusion of AD-SVF via IV and Intranasal

• Registration Number: NCT02912169
• Lead Sponsor: Ageless Regenerative Institute

Brief Summary

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?

Detailed Description

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.

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Status Verified: 2017-11
• Primary Completion: 2017-11-15
• Study Completion: 2017-11-15
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Adipose-derived Stromal Vascular Fraction infusion	Infusion of AD-SVF via IV and Intranasal	Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF infusion) intravenous (IV) and Intranasal.
Autologous Adipose-derived Stromal Vascular Fraction infusion	Liposuction under local anesthesia	Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF infusion) intravenous (IV) and Intranasal.

Primary Outcome Measures

Name	Time	Method
Clinical Improvement in Mini Mental State Examination (MMSE)	Six months after therapy	Improvement in MMSE six months after therapy

Secondary Outcome Measures

Name	Time	Method
Adverse Event	One year after stem cell therapy	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.
Clinical Improvement in Functional Activities Questionnaire (FAQ)	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

Trial Locations

Locations (1)

Ageless Regenerative Institute LLC; 🇺🇸 Aventura, Florida, United States