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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

NCT04228666 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

BIOLOGICAL

HB-adMSCs

Four IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory data will be collected prior to first infusion; follow-up data will be compared against baseline according to the following schedule: safety laboratory tests follow-up on weeks 4, 8, 13, 26, and 52; inflammation and amyloid markers follow-up on weeks 13 and 52; MMSE and ADCS-ADL follow-up on weeks 13, 19, 26, 33, 40, 46 and 52; Altoida NMI follow-up will occur weekly from week 0 to week 52; CDR follow-up will occur weeks 4, 10, 13, 19, 26, 33, 40, 46 and 52; C-SSRS follow-up will occur on weeks 4, 10, 26, and 52; Amyloid PET imaging follow-up occurs week 26 and 52;

Sponsors & Collaborators

  • Hope Biosciences Research Foundation

    collaborator INDUSTRY

  • Hope Biosciences LLC

    lead INDUSTRY

Principal Investigators

  • Djamchid Lotfi, MD · Clinical Trial Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-02-01
Completion
2022-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04228666 on ClinicalTrials.gov