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

NCT02912169 | Withdrawn Phase 1

• 1 other identifier: AD-US-ALZ-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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?

Conditions

Alzheimer's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement in Mini Mental State Examination (MMSE)

  Improvement in MMSE six months after therapy

  Six months after therapy

Secondary Outcomes (5)

• Adverse Event

  One year after stem cell therapy

• 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

Study Arms (1)

Autologous Adipose-derived Stromal Vascular Fraction infusion

EXPERIMENTAL

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

Interventions

Liposuction under local anesthesia PROCEDURE

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

Also known as: Lipoaspiration, Adipose tissue harvesting

Autologous Adipose-derived Stromal Vascular Fraction infusion

Infusion of AD-SVF via IV and Intranasal BIOLOGICAL

IV and Intranasal Infusion of isolated AD-SVF

Autologous Adipose-derived Stromal Vascular Fraction infusion

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ageless Regenerative Institute: lead

Study Sites (1)

Ageless Regenerative Institute LLC

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sharon McQuillan, MD

  Ageless Regenerative Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: September 23, 2016
• Study Start: November 1, 2015
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

US (1)