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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02912169
• Other study ID #: AD-US-ALZ-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: April 6, 2016
• Last updated: November 21, 2017
• Start date: November 1, 2015
• Est. completion date: November 15, 2017

Study information

• Verified date: November 2017
• Source: Ageless Regenerative Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 15, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Procedure:
• Liposuction under local anesthesia
Procedure will be performed via liposuction to harvest Adipose-derived stromal vascular fraction cells.

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

Locations

Country	Name	City	State
United States	Ageless Regenerative Institute LLC	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ageless Regenerative Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Improvement in Mini Mental State Examination (MMSE)	Improvement in MMSE six months after therapy	Six months after therapy
Secondary	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.	One year after stem cell therapy
Secondary	Clinical Improvement in Functional Activities Questionnaire (FAQ)		Three and six months after therapy
Secondary	Clinical Improvement in Activities of Daily Living Questionnaire (ADL)		Three and six months after therapy
Secondary	Clinical Improvement in Geriatric Depression Scale (GDS)		Three and six months after therapy
Secondary	Clinical Improvement in Mini Mental State Examination (MMSE)		Three months after therapy