Clinical trial NCT02912169: 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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Alzheimer's
Stem cell
Adipose-derived stem cells
ASC
ADSC
Lead sponsor: Ageless Regenerative Institute
Sponsor class: INDUSTRY
First posted: 2016-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Improvement in Mini Mental State Examination (MMSE)
timeFrame: Six months after therapy
Secondary outcomes:
measure: Adverse Event
timeFrame: One year after stem cell therapy
measure: Clinical Improvement in Functional Activities Questionnaire (FAQ)
timeFrame: Three and six months after therapy
measure: Clinical Improvement in Activities of Daily Living Questionnaire (ADL)
timeFrame: Three and six months after therapy
measure: Clinical Improvement in Geriatric Depression Scale (GDS)
timeFrame: Three and six months after therapy
measure: Clinical Improvement in Mini Mental State Examination (MMSE)
timeFrame: Three months after therapy
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Ageless Regenerative Institute LLC
state: Florida
Study officials:
affiliation: Ageless Regenerative Institute
name: Sharon McQuillan, MD
role: PRINCIPAL_INVESTIGATOR
References: