CClinicalTrials.gg
WithdrawnNCT02912169Updated Nov 24, 2017

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

A Phase 1/2 interventional study of Liposuction under local anesthesia and Infusion of AD-SVF via IV and Intranasal in Alzheimer's Disease, sponsored by Ageless Regenerative Institute. Withdrawn at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-11-24.

Sponsored by Ageless Regenerative Institute · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
company dissolved
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
55 Years to 85 Years
Sex
All
01

Study 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?

Read the 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.

02

Conditions studied

  • Alzheimer's Disease

Browse trials for

Keywords

  • Alzheimer's Disease
  • Alzheimer's
  • Stem cell
  • Adipose-derived stem cells
  • ASC
  • ADSC
03

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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 · Biological: Infusion of AD-SVF via IV and Intranasal

Interventions

  • ProcedureLiposuction under local anesthesia

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

    Also known as: Lipoaspiration, Adipose tissue harvesting

  • BiologicalInfusion of AD-SVF via IV and Intranasal

    IV and Intranasal Infusion of isolated AD-SVF

05

What researchers measure

Primary outcomes

  1. Clinical Improvement in Mini Mental State Examination (MMSE)

    Improvement in MMSE six months after therapy

    Time frame: Six months after therapy

Secondary outcomes

  1. Adverse Event

    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.

    Time frame: One year after stem cell therapy

  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

06

Study locations

1 site
  • Ageless Regenerative Institute LLC
    Aventura, Florida 33180, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02912169
Lead sponsor
Ageless Regenerative Institute
Responsible party
Sponsor
First posted
Sep 23, 2016
Start date
Nov 1, 2015
Primary completion
Nov 15, 2017
Completion
Nov 15, 2017
Last update
Nov 24, 2017

Study contacts

Sharon McQuillan, MD
principal investigator · Ageless Regenerative Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion