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

NCT ID: NCT02912169

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-01

Study Completion Date

2017-11-15

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's Disease Alzheimer's Stem cell Adipose-derived stem cells ASC ADSC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous Adipose-derived Stromal Vascular Fraction infusion

Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF infusion) intravenous (IV) and Intranasal.

Group Type EXPERIMENTAL

Liposuction under local anesthesia

Intervention Type PROCEDURE

Procedure will be performed via liposuction to harvest Adipose-derived stromal vascular fraction cells.

Infusion of AD-SVF via IV and Intranasal

Intervention Type BIOLOGICAL

IV and Intranasal Infusion of isolated AD-SVF

Interventions

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Liposuction under local anesthesia

Procedure will be performed via liposuction to harvest Adipose-derived stromal vascular fraction cells.

Intervention Type PROCEDURE

Infusion of AD-SVF via IV and Intranasal

IV and Intranasal Infusion of isolated AD-SVF

Intervention Type BIOLOGICAL

Other Intervention Names

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Lipoaspiration Adipose tissue harvesting

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ageless Regenerative Institute

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon McQuillan, MD

Role: PRINCIPAL_INVESTIGATOR

Ageless Regenerative Institute

Locations

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Ageless Regenerative Institute LLC

Aventura, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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AD-US-ALZ-001

Identifier Type: -

Identifier Source: org_study_id