A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Alzheimer's Disease

Hope Biosciences LLC1 site in 1 countryMarch 1, 2020

ConditionsAlzheimer Disease

InterventionsHB-adMSCs

Overview

Phase: Phase 1
Intervention: HB-adMSCs
Conditions: Alzheimer Disease
Sponsor: Hope Biosciences LLC
Locations: 1
Primary Endpoint: Calcium
Status: Withdrawn
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Hope Biosciences is conducting a research study of an investigational product called autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as a possible treatment for Alzheimer's disease (AD). The study purpose is to evaluate the safety profile of four IV infusions of HB-adMSCs in subjects with clinical diagnosis of AD.

Detailed Description

This is a Phase 1/2a, open-label, non-randomized study in subjects with Alzheimer's disease. 24 patients will be enrolled for the study. The overall objective of this study is to evaluate the safety profile of four IV infusions of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of AD. The primary endpoint of this study is to measure the number and frequency of adverse event(s) and/or severe adverse event(s) throughout the study duration. The second endpoint of this study is to evaluate the ability of HB-adMSCs to alter AD-related inflammation via measuring levels of Tumor Necrosis Factor alpha (TNF-a), Interleukin-1 (IL-1), Interleukin-6 (IL-6), C-Reactive Protein (CRP), and markers associated with amyloid deposition, Amyloid beta 40 and Amyloid beta 42. Subjects will also be assessed for cognitive deficits measured by changes from baseline values using Mini Mental Status Examination (MMSE), Alzheimer's disease Cooperative Study Activities of Daily Living (ADCS-ADL), Alzheimer's disease Related Quality of Life (ADRQL), Altoida Neuro Motor Index (NMI) for Digital Biomarkers, and Clinical Dementia Rating Questionnaire (CDR).

Registry

clinicaltrials.gov

Start Date

March 1, 2020

End Date

February 1, 2022

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hope Biosciences LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of early stage's (preclinical/mild cognitive impairment) Probable Alzheimer's Disease according to the 2011 NIA-AA criteria.
•Non-childbearing potential for women is defined as postmenopausal \[last natural menses greater than 24 months; in women under age 55, menopausal status will be documented with serum follicle stimulating hormone (FSH) test\] or undergone a documented bilateral tubal ligation or hysterectomy.
•Male participants who are sexually active with a woman of childbearing potential must agree to use condoms during the trial unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of intrauterine device (IUD), male or female condom and diaphragm.
•Informed consent signed by the subject
•Documented Amyloid PET Scan (images and report) positive to amyloid plaques deposits on the brain.
•If the patient is under any treatment, should have been on a stable dose for at least 30 days prior to signing the informed consent form and there is no intention to modify the dose over the course of the study. (NOTE: Cholinesterase inhibitors (AChEI) (donepezil, galantamine, or rivastigmine) may not be initiated, discontinued or modified after study initiation for the 12-months control period).

Exclusion Criteria

•Hospitalization or change of chronic concomitant medication within one month prior to screening.
•Clinically significant or unstable disease that may interfere with outcome evaluations, including but not limited to:
•Respiratory Insufficiency
•Poorly managed hypertension (systolic \>160 mm Hg and/or diastolic \>95 mm Hg) or hypotension (systolic \<90 mm Hg and/or diastolic \<60 mm Hg); or
•Bradycardia (\<50 beats/min.) or tachycardia (\>100 beats/min.). Otherwise healthy subjects with borderline bradycardia may be discussed with the medical monitor to determine eligibility.
•Renal insufficiency, defined as eGFR \<40 mL/min based on the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula, https://www.mdcalc.com/ckd-epi-equations-glomerular-filtration-rate-gfr
•Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 3 months before screening). If a subject has a history of heart disease of questionable clinical significance, the medical monitor may be contacted to discuss eligibility.
•Records of PET Scan negative to Amyloid plaques deposition in the brain.
•Suspected or known drug or alcohol abuse, i.e. more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day.
•Acute intercurrent infections such as Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV) or Syphilis.

Arms & Interventions

HB-adMSCs

HB-adMSCs are autologous, adipose-derived mesenchymal stem cells. Four intravenous infusions will be administered on weeks 0, 2, 6, and 8 at a dose of 2 x 10\^8 total HB-adMSC cells.

Intervention: HB-adMSCs