search
Back to results

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

Primary Purpose

Alzheimer's Disease

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Liposuction under local anesthesia
Infusion of AD-SVF via IV and Intranasal
Sponsored by
Ageless Regenerative Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Alzheimer's, Stem cell, Adipose-derived stem cells, ASC, ADSC

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ageless Regenerative Institute LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Adipose-derived Stromal Vascular Fraction infusion

Arm Description

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

Outcomes

Primary Outcome Measures

Clinical Improvement in Mini Mental State Examination (MMSE)
Improvement in MMSE six months after therapy

Secondary Outcome Measures

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.
Clinical Improvement in Functional Activities Questionnaire (FAQ)
Clinical Improvement in Activities of Daily Living Questionnaire (ADL)
Clinical Improvement in Geriatric Depression Scale (GDS)
Clinical Improvement in Mini Mental State Examination (MMSE)

Full Information

First Posted
April 6, 2016
Last Updated
November 21, 2017
Sponsor
Ageless Regenerative Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02912169
Brief Title
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
company dissolved
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ageless Regenerative Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, Alzheimer's, Stem cell, Adipose-derived stem cells, ASC, ADSC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Adipose-derived Stromal Vascular Fraction infusion
Arm Type
Experimental
Arm Description
Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF infusion) intravenous (IV) and Intranasal.
Intervention Type
Procedure
Intervention Name(s)
Liposuction under local anesthesia
Other Intervention Name(s)
Lipoaspiration, Adipose tissue harvesting
Intervention Description
Procedure will be performed via liposuction to harvest Adipose-derived stromal vascular fraction cells.
Intervention Type
Biological
Intervention Name(s)
Infusion of AD-SVF via IV and Intranasal
Intervention Description
IV and Intranasal Infusion of isolated AD-SVF
Primary Outcome Measure Information:
Title
Clinical Improvement in Mini Mental State Examination (MMSE)
Description
Improvement in MMSE six months after therapy
Time Frame
Six months after therapy
Secondary Outcome Measure Information:
Title
Adverse Event
Description
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
Title
Clinical Improvement in Functional Activities Questionnaire (FAQ)
Time Frame
Three and six months after therapy
Title
Clinical Improvement in Activities of Daily Living Questionnaire (ADL)
Time Frame
Three and six months after therapy
Title
Clinical Improvement in Geriatric Depression Scale (GDS)
Time Frame
Three and six months after therapy
Title
Clinical Improvement in Mini Mental State Examination (MMSE)
Time Frame
Three months after therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon McQuillan, MD
Organizational Affiliation
Ageless Regenerative Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ageless Regenerative Institute LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs