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

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ClinicalTrials.gov Identifier: NCT02912169
Recruitment Status : Withdrawn (company dissolved)
First Posted : September 23, 2016
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
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?

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Procedure: Liposuction under local anesthesia Biological: Infusion of AD-SVF via IV and Intranasal Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autologous Adipose-derived Stromal Vascular Fraction infusion
Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF infusion) intravenous (IV) and Intranasal.
Procedure: Liposuction under local anesthesia
Procedure will be performed via liposuction to harvest Adipose-derived stromal vascular fraction cells.
Other Names:
  • Lipoaspiration
  • Adipose tissue harvesting

Biological: Infusion of AD-SVF via IV and Intranasal
IV and Intranasal Infusion of isolated AD-SVF




Primary Outcome Measures :
  1. Clinical Improvement in Mini Mental State Examination (MMSE) [ Time Frame: Six months after therapy ]
    Improvement in MMSE six months after therapy


Secondary Outcome Measures :
  1. Adverse Event [ Time Frame: 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.

  2. Clinical Improvement in Functional Activities Questionnaire (FAQ) [ Time Frame: Three and six months after therapy ]
  3. Clinical Improvement in Activities of Daily Living Questionnaire (ADL) [ Time Frame: Three and six months after therapy ]
  4. Clinical Improvement in Geriatric Depression Scale (GDS) [ Time Frame: Three and six months after therapy ]
  5. Clinical Improvement in Mini Mental State Examination (MMSE) [ Time Frame: Three months after therapy ]


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912169


Locations
United States, Florida
Ageless Regenerative Institute LLC
Aventura, Florida, United States, 33180
Sponsors and Collaborators
Ageless Regenerative Institute
Investigators
Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT02912169     History of Changes
Other Study ID Numbers: AD-US-ALZ-001
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ageless Regenerative Institute:
Alzheimer's Disease
Alzheimer's
Stem cell
Adipose-derived stem cells
ASC
ADSC

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders