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Alzheimer DiseasePhase 1/2NCT04228666

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

A Phase 1/2 study testing HB-adMSCs in people with Alzheimer Disease, run by Hope Biosciences LLC at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
HB-adMSCs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Mar 2020to 1 Feb 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 14Show fewer
  • 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.
  • Contraindications for PET scanning, including implanted metallic devices (e.g. non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces.
  • Is unable or unwilling to comply with protocol follow-up requirements.
  • Enrollment in another investigational study or intake of investigational drug within the previous 30 days.
  • Any condition, which in the opinion of the investigator or the sponsor makes the patient unsuitable for inclusion.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Trial Network

    Houston, Texas, 77074

Other trials in United States

About this study

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.

Read the 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).

Being tested
HB-adMSCs
Keywords
Alzheimer's disease, stem cells, adipose derived mesenchymal stem cells
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HB-adMSCsBiological

    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;

Study groups in NCT04228666
Study groupRoleWhat they receive
HB-adMSCsExperimentalHB-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.
Receives: Biological: HB-adMSCs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose

    clinical lab evaluation of level of glucose in the blood (mg/dL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  2. Calcium

    clinical lab evaluation of level of calcium in the blood (mg/dL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  3. Albumin

    clinical lab evaluation of level of albumin in the blood (g/dL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  4. Total Protein

    clinical lab evaluation of level of protein in the blood (g/dL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  5. Sodium

    clinical lab evaluation of level of sodium in the blood (mol/L)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  6. Total carbon dioxide

    clinical lab evaluation of level of carbon dioxide in the blood (mmol/L)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  7. Potassium

    clinical lab evaluation of level of potassium in the blood (mmol/L)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  8. Chloride

    clinical lab evaluation of level of chloride in the blood (mmol/L)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  9. BUN

    clinical lab evaluation of level of BUN in the blood (mg/dL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  10. Creatinine

    clinical lab evaluation of level of creatinine in the blood (mg/dL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  11. Alkaline phosphatase

    clinical lab evaluation of level of alkaline phosphatase in the blood (IU/L)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  12. Alanine aminotransferase

    clinical lab evaluation of level of alanine aminotransferase in the blood (IU/L)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  13. Aspartate aminotransferase

    clinical lab evaluation of level of aspartate aminotransferase in the blood (IU/L)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  14. Total Bilirubin

    clinical lab evaluation of level of bilirubin in the blood (mg/dL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  15. White blood cell

    clinical lab evaluation of level of white blood cells in the blood (x 10^3/uL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  16. Red blood cell

    clinical lab evaluation of level of red blood cells in the blood (x 10^6/uL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  17. Hemoglobin

    clinical lab evaluation of level of hemoglobin in the blood (g/dL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  18. Hematocrit

    clinical lab evaluation of level of hematocrit in the blood (%)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  19. Mean corpuscular volume

    clinical lab evaluation of mean corpuscular volume in the blood (fL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  20. Mean corpuscular hemoglobin

    clinical lab evaluation of mean corpuscular hemoglobin in the blood (pg)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  21. Mean corpuscular hemoglobin concentration

    clinical lab evaluation of level of hemoglobin concentration in the blood (g/dL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  22. Red cell distribution width

    clinical lab evaluation of distribution width in the blood (%)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  23. Neutrophils

    clinical lab evaluation of neutrophils in the blood (%)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  24. Lymphs

    clinical lab evaluation of lymphocytes in the blood (%)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  25. Monocytes

    clinical lab evaluation of monocytes in the blood (%)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  26. Eos

    clinical lab evaluation of eosinophils in the blood (%)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  27. Basophils

    clinical lab evaluation of basophils in the blood (%)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  28. Absolute neutrophils

    clinical lab evaluation of absolute neutrophils in the blood (x 10^3/uL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  29. Absolute lymphs

    clinical lab evaluation of absolute lymphocytes in the blood (x 10^3/uL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  30. Absolute monocytes

    clinical lab evaluation of absolute monocytes in the blood (x 10^3/uL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  31. Absolute Eos

    clinical lab evaluation of absolute eosinophils in the blood (x 10^3/uL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  32. Absolute Basos

    clinical lab evaluation of absolute basophils in the blood (x 10^3/uL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  33. Immature granulocytes

    clinical lab evaluation of granulocytes in the blood (%)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  34. Absolute Immature granulocytes

    clinical lab evaluation of absolute immature granulocytes in the blood (x 10^3/uL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  35. Platelets

    clinical lab evaluation of platelets in the blood (x 10^3/uL)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  36. Prothrombin time

    clinical lab evaluation of time for blood to coagulate (seconds)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

  37. INR

    clinical lab evaluation of international normalized ratio of blood coagulation (no unit)

    Measured: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.

Secondary outcomes (12)

  1. Tumor necrosis factor-alpha

    measure level of TNFa in blood (pg/ml)

    Measured: week 0, change from baseline at week 13, change from baseline at week 52

  2. Interleukin-1

    measure of IL-1 in the blood (pg/ml)

    Measured: week 0, change from baseline at week 13, change from baseline at week 52

  3. Interleukin-6

    measure of IL-6 in the blood (pg/ml)

    Measured: week 0, change from baseline at week 13, change from baseline at week 52

  4. C-reactive protein

    measure of CRP in the blood (mg/L)

    Measured: week 0, change from baseline at week 13, change from baseline at week 52

  5. Amyloid beta 40

    measure of AB40 in the blood (pg/ml)

    Measured: week 0, change from baseline at week 13, change from baseline at week 52

  6. Amyloid beta 42

    measure of AB42 in the blood (pg/ml)

    Measured: week 0, change from baseline at week 13, change from baseline at week 52

  7. Volumetric changes in hippocampus, ventriculus, and whole brain

    volume change from screening

    Measured: screening, week 26 and 52

  8. Mini Mental Status Exam

    Change from baseline score; scores from 0 to 30, lower score indicates more severe dementia

    Measured: week 0, change from baseline at week 4, 10, 13, 19, 26, 33, 40, 46, and 52

  9. Alzheimer's disease Cooperative Study Activities of Daily Living

    Change from baseline score; scores from 0 to 53, lower score indicates greater functional impairment

    Measured: week 0, change from baseline at week 4, 10, 13, 19, 26, 33, 40, 46, and 52

  10. Quality of Life Enjoyment and Satisfaction Questionnaire

    Change from baseline score; total score range is 14 to 70, higher scores indicate more enjoyment and satisfaction with life

    Measured: week 0, change from baseline at week 4, 10, 13, 19, 26, 33, 40, 46, and 52

  11. Altoida Neuro Motor Index

    Change from baseline score; score ranges from 0 to 100, higher score indicates less impairment

    Measured: week 0, change from baseline at week 4, 10, 13, 19, 26, 33, 40, 46, and 52

  12. Clinical Dementia Rating Questionnaire

    Change from baseline score; scores range fro 0 to 3, higher scores indicates more severe impairment

    Measured: week 0, change from baseline at week 4, 10, 13, 19, 26, 33, 40, 46, and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2020
  2. Study start1 Mar 2020
  3. Primary completion1 Feb 2022 (estimated)
  4. Study completion1 Feb 2022 (estimated)

Why it stopped: Due to COVID 19 Pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04228666
Sponsor's protocol ID
HBALZ01
Status last verified
Sep 2025
First submitted
3 Jan 2020
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HB-adMSCs in people with Alzheimer Disease, run by Hope Biosciences LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucose (time frame: Screening, change from screening at week 0, week 4, week 8, week 13, week 26, week 52.). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04228666.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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