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A Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease

Trial Profile

A Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Jul 2020

At a glance

  • Drugs HB-adMSC (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Sponsors Hope Biosciences
  • Most Recent Events

    • 28 Apr 2020 Planned initiation date (estimated date for recruitment of the first subject) changed from 16 Apr 2020 to 7 May 2020.
    • 23 Apr 2020 According to a Hope Biosciences media release, this study is funded by the Hope Biosciences Stem Cell Research Foundation.
    • 23 Apr 2020 According to a Hope Biosciences media release, Hope Biosciences Stem Cell Research Foundation successfully completes the first 10 treatments for immune support against COVID-19.

Trial Overview

Purpose

This Phase II study is a single arm, non-randomized study that is expected to enroll 75 participants that are either 50 years of age, have preexisting health conditions, or are at high-exposure risk. The study's primary objective is to determine the efficacy of HB-adMSCs to prepare the immune system so that it is better able to fight the virus, should one become infected. We anticipate that this pretreatment will limit the progression and severity of COVID-19, ultimately keeping patients out of the hospital and off of mechanical ventilation.

Primary Endpoints

Incidence of hospitalization for COVID-19

description: Number of subjects that require hospitalization for COVID-19
time_frame: Week 0 through week 26 (end of study)

Incidence of symptoms for COVID-19

description: Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough
time_frame: week 0 through week 26 end of study (end of study)

Other Endpoints

absence of upper/lower respiratory infection

description: absence of upper/lower respiratory infection by hospitalization criteria
time_frame: Weeks 0 through 26

Glucose

description: clinical lab evaluation of level of glucose in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26

Calcium

description: clinical lab evaluation of level of calcium in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26

Albumin

description: clinical lab evaluation of level of albumin in the blood (g/dL)
time_frame: Weeks 0, 6, 14, 26

Total Protein

description: clinical lab evaluation of level of total protein in the blood (g/dL)
time_frame: Weeks 0, 6, 14, 26

Sodium

description: clinical lab evaluation of level of sodium in the blood (mol/L)
time_frame: Weeks 0, 6, 14, 26

Total carbon dioxide

description: clinical lab evaluation of level of carbon dioxide in the blood (mmol/L)
time_frame: Weeks 0, 6, 14, 26

Potassium

description: clinical lab evaluation of level of potassium in the blood (mmol/L)
time_frame: Weeks 0, 6, 14, 26

Chloride

description: clinical lab evaluation of level of chloride in the blood (mmol/L)
time_frame: Weeks 0, 6, 14, 26

BUN

description: clinical lab evaluation of level of BUN in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26

Creatinine

description: clinical lab evaluation of level of creatinine in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26

Alkaline phosphatase

description: clinical lab evaluation of level of alkaline phosphatase in the blood (IU/L)
time_frame: Weeks 0, 6, 14, 26

Alanine aminotransferase

description: clinical lab evaluation of level of alanine aminotransferase in the blood (IU/L)
time_frame: Weeks 0, 6, 14, 26

Aspartate aminotransferase

description: clinical lab evaluation of level of aspartate aminotransferase in the blood (IU/L)
time_frame: Weeks 0, 6, 14, 26

Total bilirubin

description: clinical lab evaluation of level of total bilirubin in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26

White blood cells

description: clinical lab evaluation of level of white blood cells in the blood (x 10^3/uL)
time_frame: Weeks 0, 6, 14, 26

Red blood cells

description: clinical lab evaluation of level of red blood cells in the blood (x 10^6/uL)
time_frame: Weeks 0, 6, 14, 26

Hemoglobin

description: clinical lab evaluation of level of hemoglobin in the blood (g/dL)
time_frame: Weeks 0, 6, 14, 26

Hematocrit

description: clinical lab evaluation of level of hematocrit in the blood (%)
time_frame: Weeks 0, 6, 14, 26

Mean corpuscular volume

description: clinical lab evaluation of mean corpuscular volume in the blood (fL)
time_frame: Weeks 0, 6, 14, 26

Mean corpuscular hemoglobin

description: clinical lab evaluation of mean corpuscular hemoglobin in the blood (pg)
time_frame: Weeks 0, 6, 14, 26

Mean corpuscular hemoglobin concentration

description: clinical lab evaluation of mean corpuscular hemoglobin in the blood (g/dL)
time_frame: Weeks 0, 6, 14, 26

Red cell distribution width

description: clinical lab evaluation of red blood cell distribution width in the blood (%)
time_frame: Weeks 0, 6, 14, 26

Neutrophils

description: clinical lab evaluation of neutrophils in the blood (%)
time_frame: Weeks 0, 6, 14, 26

Lymphs

description: clinical lab evaluation of lymphocytes in the blood (%)
time_frame: Weeks 0, 6, 14, 26

Monocytes

description: clinical lab evaluation of monocytes in the blood (%)
time_frame: Weeks 0, 6, 14, 26

Eos

description: clinical lab evaluation of eosinophils in the blood (%)
time_frame: Weeks 0, 6, 14, 26

Basophils

description: clinical lab evaluation of basophils in the blood (%)
time_frame: Weeks 0, 6, 14, 26

Absolute neutrophils

description: clinical lab evaluation of absolute neutrophils in the blood (x 10^3/uL)
time_frame: Weeks 0, 6, 14, 26

Absolute lymphs

description: clinical lab evaluation of absolute lymphs in the blood (x 10^3/uL)
time_frame: Weeks 0, 6, 14, 26

Absolute monocytes

description: clinical lab evaluation of absolute monocytes in the blood (x 10^3/uL)
time_frame: Weeks 0, 6, 14, 26

Absolute eosinophils

description: clinical lab evaluation of absolute eosinophils in the blood (x 10^3/uL)
time_frame: Weeks 0, 6, 14, 26

Absolute basophils

description: clinical lab evaluation of absolute basophils in the blood (x 10^3/uL)
time_frame: Weeks 0, 6, 14, 26

Immature granulocytes

description: clinical lab evaluation of granulocytes in the blood (%)
time_frame: Weeks 0, 6, 14, 26

Absolute Immature granulocytes

description: clinical lab evaluation of granulocytes in the blood (x 10^3/uL)
time_frame: Weeks 0, 6, 14, 26

Platelets

description: clinical lab evaluation of platelets in the blood (x 10^3/uL)
time_frame: Weeks 0, 6, 14, 26

Prothrombin time

description: clinical lab evaluation of time for blood to coagulate (seconds)
time_frame: Weeks 0, 6, 14, 26

INR

description: clinical lab evaluation of international normalized ratio of blood coagulation (no unit)
time_frame: Weeks 0, 6, 14, 26

TNFalpha

description: clinical lab evaluation of tumor necrosis factor alpha in the blood (pg/mL)
time_frame: Weeks 0, 6, 14, 26

Interleukin-6

description: clinical lab evaluation of interleukin-6 in the blood (pg/mL)
time_frame: Weeks 0, 6, 14, 26

Interleukin-10

description: clinical lab evaluation of interleukin-10 in the blood (pg/mL)
time_frame: Weeks 0, 6, 14, 26

C-reactive protein

description: clinical lab evaluation of interleukin-10 in the blood (mg/L)
time_frame: Weeks 0, 6, 14, 26

SF-36

description: Short-form 36 Health Survey; scored on a scale of 0-100; lower score equals more disability.
time_frame: Weeks 0, 6, 14, 26

PHQ-9

description: Depression module; scores DSM-IV criteria 0-3 to monitor severity of depression.
time_frame: Weeks 0, 6, 14, 26 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients & volunteers
  • Number

    Planned: 75

  • Sex male & female
  • Age Group ≥ 18 years; Adult

Patient Inclusion Criteria

Subjects must meet the criteria for 1,2, OR 3, AND 4-7 to be eligible. 1. Men, and women over 65 years of age inclusively (according to CDC provisions) OR 2. Participant works in healthcare facility or other well characterized high-risk environment OR 3. Has underlying conditions including but not limited to cardiopathies, diabetes mellitus, cancer, COPD, asthma or any other systemic autoimmune disease. 4. Subject must have previously banked their cells at Hope Biosciences 5. No signs or symptoms of infection, including but not limited to, body temperature >100 F and pulse rate > 100 BPM. 6. Subject provides written informed consent prior to initiation of any study procedures. 7. Agrees to the collection of venous blood per protocol.

Patient Exclusion Criteria

Subjects must not have any of the following criteria to be eligible. 1. Patients who are participating in other clinical trials or have intake of investigational drug within the previous 30 days; 2. Inability to provide informed consent or to comply with test requirements; 3. Any medical disease or condition that, in the opinion of the site PI or sub-investigator, precludes study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. 4. Patients who have received a stem cell treatment within one year. 5. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.

Trial Details

Identifiers

Identifier Owner
NCT04349631 ClinicalTrials.gov: US National Institutes of Health
Protection-Against-COVID19 -

Organisations

  • Sponsors Hope Biosciences
  • Affiliations Hope Biosciences

Trial Dates

  • Initiation Dates

    Planned : 07 May 2020

    Actual : 22 Apr 2020

  • Primary Completion Dates

    Planned : 31 Dec 2020

  • End Dates

    Planned : 31 Dec 2020

Other Details

  • Design open; prospective
  • Phase of Trial Phase II
  • Location USA
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
HB-adMSCPrimary Drug Intravenous Infusion

HB-adMSCs

Five 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 lab follow ups at weeks 6, 14, 26; inflammatory marker follow ups at weeks 6, 14, 26; SF-36 and PHQ-9 Questionnaires at weeks 2,6,10, 14, 18, 22, 26.
Drug: HB-adMSCs (Five IV infusion of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2,6,10,14,18,22,26.)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Thanh Cheng, MD Hope Biosciences Stem Cell Research Foundation USA

Centres

Centre Name Location Trial Centre Country
Hope Biosciences
-
-
Hope Biosciences Stem Cell Research Foundation Sugar Land, Texas USA

Trial History

Event Date Event Type Comment
15 Jul 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 15 Jul 2020
28 Apr 2020 Other trial event Planned initiation date (estimated date for recruitment of the first subject) changed from 16 Apr 2020 to 7 May 2020. Updated 04 May 2020
23 Apr 2020 Other trial event According to a Hope Biosciences media release, this study is funded by the Hope Biosciences Stem Cell Research Foundation. Updated 27 Apr 2020
23 Apr 2020 Other trial event According to a Hope Biosciences media release, Hope Biosciences Stem Cell Research Foundation successfully completes the first 10 treatments for immune support against COVID-19. Updated 27 Apr 2020
20 Apr 2020 Other trial event New source identified and integrated ClinicalTrials.gov: US National Institutes of Health (NCT04349631) Updated 20 Apr 2020
14 Apr 2020 Status change - recruiting Status changed from planning to recruiting. Updated 20 Apr 2020
08 Apr 2020 New trial record New trial record Updated 08 Apr 2020
06 Apr 2020 Other trial event According to a Hope Biosciences media release, U.S. FDA has approved to commence Phase II stem cell clinical trial for protection against COVID-19. Updated 08 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Hope Biosciences. Hope Biosciences Receives FDA Approval to Commence First Stem Cell Clinical Trial for Protection Against COVID-19. Media-Rel 2020;.

    Media Release
  3. Hope Biosciences. Hope Biosciences Receives Second FDA Clearance for a Phase II Clinical Trial for Protection Against COVID-19. Media-Rel 2020;.

    Media Release
  4. Hope Biosciences. Hope Biosciences Stem Cell Research Foundation Completes First Treatments for COVID-19. Media-Rel 2020;.

    Media Release
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