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A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HB-adMSCs
Sponsored by
Hope Biosciences Stem Cell Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Coronavirus, Prevention, Immune support, stem cells, mesenchymal stem cells, adipose-derived mesenchymal stem cells

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

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.

Sites / Locations

  • Hope Biosciences Stem Cell Research Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HB-adMSCs

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of hospitalization for COVID-19
Number of subjects that require hospitalization for COVID-19
Incidence of symptoms for COVID-19
Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough

Secondary Outcome Measures

absence of upper/lower respiratory infection
absence of upper/lower respiratory infection by hospitalization criteria
Glucose
clinical lab evaluation of level of glucose in the blood (mg/dL)
Calcium
clinical lab evaluation of level of calcium in the blood (mg/dL)
Albumin
clinical lab evaluation of level of albumin in the blood (g/dL)
Total Protein
clinical lab evaluation of level of total protein in the blood (g/dL)
Sodium
clinical lab evaluation of level of sodium in the blood (mol/L)
Total carbon dioxide
clinical lab evaluation of level of carbon dioxide in the blood (mmol/L)
Potassium
clinical lab evaluation of level of potassium in the blood (mmol/L)
Chloride
clinical lab evaluation of level of chloride in the blood (mmol/L)
BUN
clinical lab evaluation of level of BUN in the blood (mg/dL)
Creatinine
clinical lab evaluation of level of creatinine in the blood (mg/dL)
Alkaline phosphatase
clinical lab evaluation of level of alkaline phosphatase in the blood (IU/L)
Alanine aminotransferase
clinical lab evaluation of level of alanine aminotransferase in the blood (IU/L)
Aspartate aminotransferase
clinical lab evaluation of level of aspartate aminotransferase in the blood (IU/L)
Total bilirubin
clinical lab evaluation of level of total bilirubin in the blood (mg/dL)
White blood cells
clinical lab evaluation of level of white blood cells in the blood (x 10^3/uL)
Red blood cells
clinical lab evaluation of level of red blood cells in the blood (x 10^6/uL)
Hemoglobin
clinical lab evaluation of level of hemoglobin in the blood (g/dL)
Hematocrit
clinical lab evaluation of level of hematocrit in the blood (%)
Mean corpuscular volume
clinical lab evaluation of mean corpuscular volume in the blood (fL)
Mean corpuscular hemoglobin
clinical lab evaluation of mean corpuscular hemoglobin in the blood (pg)
Mean corpuscular hemoglobin concentration
clinical lab evaluation of mean corpuscular hemoglobin in the blood (g/dL)
Red cell distribution width
clinical lab evaluation of red blood cell distribution width in the blood (%)
Neutrophils
clinical lab evaluation of neutrophils in the blood (%)
Lymphs
clinical lab evaluation of lymphocytes in the blood (%)
Monocytes
clinical lab evaluation of monocytes in the blood (%)
Eos
clinical lab evaluation of eosinophils in the blood (%)
Basophils
clinical lab evaluation of basophils in the blood (%)
Absolute neutrophils
clinical lab evaluation of absolute neutrophils in the blood (x 10^3/uL)
Absolute lymphs
clinical lab evaluation of absolute lymphs in the blood (x 10^3/uL)
Absolute monocytes
clinical lab evaluation of absolute monocytes in the blood (x 10^3/uL)
Absolute eosinophils
clinical lab evaluation of absolute eosinophils in the blood (x 10^3/uL)
Absolute basophils
clinical lab evaluation of absolute basophils in the blood (x 10^3/uL)
Immature granulocytes
clinical lab evaluation of granulocytes in the blood (%)
Absolute Immature granulocytes
clinical lab evaluation of granulocytes in the blood (x 10^3/uL)
Platelets
clinical lab evaluation of platelets in the blood (x 10^3/uL)
Prothrombin time
clinical lab evaluation of time for blood to coagulate (seconds)
INR
clinical lab evaluation of international normalized ratio of blood coagulation (no unit)
TNFalpha
clinical lab evaluation of tumor necrosis factor alpha in the blood (pg/mL)
Interleukin-6
clinical lab evaluation of interleukin-6 in the blood (pg/mL)
Interleukin-10
clinical lab evaluation of interleukin-10 in the blood (pg/mL)
C-reactive protein
clinical lab evaluation of interleukin-10 in the blood (mg/L)
SF-36
Short-form 36 Health Survey; scored on a scale of 0-100; lower score equals more disability.
PHQ-9
Depression module; scores DSM-IV criteria 0-3 to monitor severity of depression.

Full Information

First Posted
April 6, 2020
Last Updated
May 2, 2023
Sponsor
Hope Biosciences Stem Cell Research Foundation
Collaborators
Hope Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT04349631
Brief Title
A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19
Official Title
A Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
November 24, 2020 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hope Biosciences Stem Cell Research Foundation
Collaborators
Hope Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hope Biosciences is conducting a research study of an investigational product called autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
Detailed Description
This is a Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 75 patients will be enrolled. All patients have previously banked their own mesenchymal stem cells at Hope Biosciences. Eligible participants are either over 50 years of age, have preexisting conditions, or are at high exposure risk of contracting COVID-19. The primary endpoint of this study is to provide immune support against COVID-19, measured by the percentage of participants in each category of a 7-point ordinal scale and the presence or absence of adverse events and serious adverse events related to the study drug. In addition, participants will be monitored for overall clinical status by standard clinical laboratories and inflammatory markers. Participants will complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Coronavirus, Prevention, Immune support, stem cells, mesenchymal stem cells, adipose-derived mesenchymal stem cells

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HB-adMSCs
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
HB-adMSCs
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Title
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)
Secondary Outcome Measure Information:
Title
absence of upper/lower respiratory infection
Description
absence of upper/lower respiratory infection by hospitalization criteria
Time Frame
Weeks 0 through 26
Title
Glucose
Description
clinical lab evaluation of level of glucose in the blood (mg/dL)
Time Frame
Weeks 0, 6, 14, 26
Title
Calcium
Description
clinical lab evaluation of level of calcium in the blood (mg/dL)
Time Frame
Weeks 0, 6, 14, 26
Title
Albumin
Description
clinical lab evaluation of level of albumin in the blood (g/dL)
Time Frame
Weeks 0, 6, 14, 26
Title
Total Protein
Description
clinical lab evaluation of level of total protein in the blood (g/dL)
Time Frame
Weeks 0, 6, 14, 26
Title
Sodium
Description
clinical lab evaluation of level of sodium in the blood (mol/L)
Time Frame
Weeks 0, 6, 14, 26
Title
Total carbon dioxide
Description
clinical lab evaluation of level of carbon dioxide in the blood (mmol/L)
Time Frame
Weeks 0, 6, 14, 26
Title
Potassium
Description
clinical lab evaluation of level of potassium in the blood (mmol/L)
Time Frame
Weeks 0, 6, 14, 26
Title
Chloride
Description
clinical lab evaluation of level of chloride in the blood (mmol/L)
Time Frame
Weeks 0, 6, 14, 26
Title
BUN
Description
clinical lab evaluation of level of BUN in the blood (mg/dL)
Time Frame
Weeks 0, 6, 14, 26
Title
Creatinine
Description
clinical lab evaluation of level of creatinine in the blood (mg/dL)
Time Frame
Weeks 0, 6, 14, 26
Title
Alkaline phosphatase
Description
clinical lab evaluation of level of alkaline phosphatase in the blood (IU/L)
Time Frame
Weeks 0, 6, 14, 26
Title
Alanine aminotransferase
Description
clinical lab evaluation of level of alanine aminotransferase in the blood (IU/L)
Time Frame
Weeks 0, 6, 14, 26
Title
Aspartate aminotransferase
Description
clinical lab evaluation of level of aspartate aminotransferase in the blood (IU/L)
Time Frame
Weeks 0, 6, 14, 26
Title
Total bilirubin
Description
clinical lab evaluation of level of total bilirubin in the blood (mg/dL)
Time Frame
Weeks 0, 6, 14, 26
Title
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
Title
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
Title
Hemoglobin
Description
clinical lab evaluation of level of hemoglobin in the blood (g/dL)
Time Frame
Weeks 0, 6, 14, 26
Title
Hematocrit
Description
clinical lab evaluation of level of hematocrit in the blood (%)
Time Frame
Weeks 0, 6, 14, 26
Title
Mean corpuscular volume
Description
clinical lab evaluation of mean corpuscular volume in the blood (fL)
Time Frame
Weeks 0, 6, 14, 26
Title
Mean corpuscular hemoglobin
Description
clinical lab evaluation of mean corpuscular hemoglobin in the blood (pg)
Time Frame
Weeks 0, 6, 14, 26
Title
Mean corpuscular hemoglobin concentration
Description
clinical lab evaluation of mean corpuscular hemoglobin in the blood (g/dL)
Time Frame
Weeks 0, 6, 14, 26
Title
Red cell distribution width
Description
clinical lab evaluation of red blood cell distribution width in the blood (%)
Time Frame
Weeks 0, 6, 14, 26
Title
Neutrophils
Description
clinical lab evaluation of neutrophils in the blood (%)
Time Frame
Weeks 0, 6, 14, 26
Title
Lymphs
Description
clinical lab evaluation of lymphocytes in the blood (%)
Time Frame
Weeks 0, 6, 14, 26
Title
Monocytes
Description
clinical lab evaluation of monocytes in the blood (%)
Time Frame
Weeks 0, 6, 14, 26
Title
Eos
Description
clinical lab evaluation of eosinophils in the blood (%)
Time Frame
Weeks 0, 6, 14, 26
Title
Basophils
Description
clinical lab evaluation of basophils in the blood (%)
Time Frame
Weeks 0, 6, 14, 26
Title
Absolute neutrophils
Description
clinical lab evaluation of absolute neutrophils in the blood (x 10^3/uL)
Time Frame
Weeks 0, 6, 14, 26
Title
Absolute lymphs
Description
clinical lab evaluation of absolute lymphs in the blood (x 10^3/uL)
Time Frame
Weeks 0, 6, 14, 26
Title
Absolute monocytes
Description
clinical lab evaluation of absolute monocytes in the blood (x 10^3/uL)
Time Frame
Weeks 0, 6, 14, 26
Title
Absolute eosinophils
Description
clinical lab evaluation of absolute eosinophils in the blood (x 10^3/uL)
Time Frame
Weeks 0, 6, 14, 26
Title
Absolute basophils
Description
clinical lab evaluation of absolute basophils in the blood (x 10^3/uL)
Time Frame
Weeks 0, 6, 14, 26
Title
Immature granulocytes
Description
clinical lab evaluation of granulocytes in the blood (%)
Time Frame
Weeks 0, 6, 14, 26
Title
Absolute Immature granulocytes
Description
clinical lab evaluation of granulocytes in the blood (x 10^3/uL)
Time Frame
Weeks 0, 6, 14, 26
Title
Platelets
Description
clinical lab evaluation of platelets in the blood (x 10^3/uL)
Time Frame
Weeks 0, 6, 14, 26
Title
Prothrombin time
Description
clinical lab evaluation of time for blood to coagulate (seconds)
Time Frame
Weeks 0, 6, 14, 26
Title
INR
Description
clinical lab evaluation of international normalized ratio of blood coagulation (no unit)
Time Frame
Weeks 0, 6, 14, 26
Title
TNFalpha
Description
clinical lab evaluation of tumor necrosis factor alpha in the blood (pg/mL)
Time Frame
Weeks 0, 6, 14, 26
Title
Interleukin-6
Description
clinical lab evaluation of interleukin-6 in the blood (pg/mL)
Time Frame
Weeks 0, 6, 14, 26
Title
Interleukin-10
Description
clinical lab evaluation of interleukin-10 in the blood (pg/mL)
Time Frame
Weeks 0, 6, 14, 26
Title
C-reactive protein
Description
clinical lab evaluation of interleukin-10 in the blood (mg/L)
Time Frame
Weeks 0, 6, 14, 26
Title
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
Title
PHQ-9
Description
Depression module; scores DSM-IV criteria 0-3 to monitor severity of depression.
Time Frame
Weeks 0, 6, 14, 26

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must meet the criteria for 1,2, OR 3, AND 4-7 to be eligible. Men, and women over 65 years of age inclusively (according to CDC provisions) OR Participant works in healthcare facility or other well characterized high-risk environment OR Has underlying conditions including but not limited to cardiopathies, diabetes mellitus, cancer, COPD, asthma or any other systemic autoimmune disease. Subject must have previously banked their cells at Hope Biosciences No signs or symptoms of infection, including but not limited to, body temperature >100 F and pulse rate > 100 BPM. Subject provides written informed consent prior to initiation of any study procedures. Agrees to the collection of venous blood per protocol. Exclusion Criteria: Subjects must not have any of the following criteria to be eligible. Patients who are participating in other clinical trials or have intake of investigational drug within the previous 30 days; Inability to provide informed consent or to comply with test requirements; 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. Patients who have received a stem cell treatment within one year. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thanh Cheng, MD
Organizational Affiliation
Hope Biosciences Stem Cell Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hope Biosciences Stem Cell Research Foundation
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19

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