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Trial record 1 of 1 for:    NCT04348435
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A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Allogeneic Mesenchymal Stem Cell Therapy (HB-adMSCs) to Provide Protection Against COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04348435
Recruitment Status : Enrolling by invitation
First Posted : April 16, 2020
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
Hope Biosciences Stem Cell Research Foundation
Information provided by (Responsible Party):
Hope Biosciences

Brief Summary:
Hope Biosciences is conducting a research study of an investigational product called allogeneic 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: HB-adMSCs Drug: Placebos Phase 2

Detailed Description:
This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 100 patients will be enrolled. Eligible participants are at high or very 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 subjects that develop symptoms of COVID-19. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs to Provide Immune Support Against COVID-19
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Experimental: Allogeneic HB-adMSCs 200MM
Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
Drug: HB-adMSCs
Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

Experimental: Allogeneic HB-adMSCs 100MM
Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
Drug: HB-adMSCs
Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

Experimental: Allogeneic HB-adMSCs 50MM
Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
Drug: HB-adMSCs
Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

Placebo Comparator: Placebo
Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Infusions will occur at weeks 0, 2, 6, 10, and 14.
Drug: Placebos
Saline




Primary Outcome Measures :
  1. Incidence of hospitalization for COVID-19 [ Time Frame: week 0 through week 26 (end of study) ]
    Number of subjects that must be hospitalized for COVID-19 during the conduct of this study

  2. Incidence of symptoms associated with COVID-19 [ Time Frame: week 0 through week 26 (end of study) ]
    Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough.


Secondary Outcome Measures :
  1. Absence of upper/lower respiratory infection [ Time Frame: week 0 through week 26 ]
    Number of subjects that develop upper/lower respiratory infection with hospitalization criteria

  2. Leukocyte differential [ Time Frame: weeks 0, 6, 14, 26 ]
    change from baseline in leukocyte differential

  3. C Reactive protein [ Time Frame: weeks 0, 6, 14, 26 ]
    change from baseline in C Reactive protein

  4. TNF alpha [ Time Frame: weeks 0, 6, 14, 26 ]
    change from baseline in TNF alpha

  5. IL-6 [ Time Frame: weeks 0, 6, 14, 26 ]
    change from baseline in IL-6

  6. IL-10 [ Time Frame: weeks 0, 6, 14, 26 ]
    change from baseline in IL-10

  7. Glucose [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of glucose in the blood (mg/dL)

  8. Calcium [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of calcium in the blood (mg/dL)

  9. Albumin [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of albumin in the blood (g/dL)

  10. Total protein [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of total protein in the blood (g/dL)

  11. Sodium [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of sodium in the blood (mol/L)

  12. Total carbon dioxide [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of total carbon dioxide in the blood (mmol/L)

  13. Potassium [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of potassium in the blood (mmol/L)

  14. Chloride [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of chloride in the blood (mmol/L)

  15. BUN [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of BUN in the blood (mg/dL)

  16. Creatinine [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of creatinine in the blood (mg/dL)

  17. Alkaline phosphatase [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of alkaline phosphatase in the blood (IU/L)

  18. Alanine aminotransferase [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of alanine aminotransferase in the blood (IU/L)

  19. Total bilirubin [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of total bilirubin in the blood (mg/dL)

  20. white blood cells [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of white blood cells in the blood (x 10^3/uL)

  21. red blood cells [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of red blood cells in the blood (x 10^6/uL)

  22. hemoglobin [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of hemoglobin in the blood (g/dL)

  23. hematocrit [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of hematocrit in the blood (%)

  24. mean corpuscular volume [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of mean corpuscular volume in the blood (fL)

  25. mean corpuscular hemoglobin [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of mean corpuscular hemoglobin in the blood (pg)

  26. mean corpuscular hemoglobin concentration [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of mean corpuscular hemoglobin concentration in the blood (g/dL)

  27. red cell distribution width [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of red cell distribution width in the blood (%)

  28. neutrophils [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of neutrophils in the blood (%)

  29. Lymphs [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of lymphocytes in the blood (%)

  30. Monocytes [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of monocytes in the blood (%)

  31. Eosinophils [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of eosinophils in the blood (%)

  32. Basophils [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of basophils in the blood (%)

  33. Absolute neutrophils [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of absolute neutrophils in the blood (x 10^3/uL)

  34. Absolute lymphs [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of absolute lymphocytes in the blood (x 10^3/uL)

  35. Absolute monocytes [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of absolute monocytes in the blood (x 10^3/uL)

  36. Absolute eosinophils [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of absolute eosinophils in the blood (x 10^3/uL)

  37. Absolute basophils [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of absolute basophils in the blood (x 10^3/uL)

  38. Immature granulocytes [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of immature granulocytes in the blood (x 10^3/uL)

  39. Platelets [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of platelets in the blood (x 10^3/uL)

  40. Prothrombin time [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of time for blood to coagulate (seconds)

  41. INR [ Time Frame: weeks 0, 6, 14, 26 ]
    clinical lab evaluation of international normalized ratio of blood coagulation (no unit)

  42. SF-36 [ Time Frame: weeks 0, 6, 14, 26 ]
    Short-form 36 Health Survey; scored on a scale of 0-100; lower score equals more disability

  43. PHQ-9 [ Time Frame: weeks 0, 6, 14, 26 ]
    Depression module; scores DSM-IV criteria 0-3 to monitor severity of depression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men, and women 18 years of age or older
  • Participant works in a capacity that is characterized as high-risk or very high-risk
  • High-Risk Exposure jobs are those with high potential for exposure to known or suspected sources of COVID-19.

    • First responders, health care delivery and support staff (e.g., law enforcement, fire fighters, paramedics, doctors, nurses, and other hospital staff who must enter patients' rooms) exposed to individuals potentially having COVID-19.
    • Mortuary workers involved in preparing (e.g., for burial or cremation) the bodies of people who are known to have, or suspected of having, COVID-19 at the time of their death
  • Very High-Risk Exposure jobs are those with high potential for exposure to known or suspected sources of COVID-19 during specific medical, postmortem or laboratory procedures.

    • Health care workers (e.g., doctors, nurses, dentists, paramedics, emergency medical technicians) performing aerosol-generating procedures (e.g., intubation, cough induction procedures, bronchoscopies, some dental procedures and exams or invasive specimen collection) on known or suspected COVID-19 patients
    • Health care or laboratory personnel collecting or handling specimens from known or suspected COVID-19 patients (e.g., manipulating cultures from known or suspected COVID-19 patients)
    • Morgue workers performing autopsies, which generally involve aerosol-generating procedures, on the bodies of people who are known to have, or suspected of having, COVID-19 at the time of their death
  • 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.
  • Agrees to conformational testing for SARS-CoV-2 before end of study.

Exclusion Criteria:

  • Women who are pregnant or lactating, or those who are not pregnant but do not take effective contraceptive measures
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348435


Locations
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United States, Texas
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, United States, 77478
Sponsors and Collaborators
Hope Biosciences
Hope Biosciences Stem Cell Research Foundation
Investigators
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Principal Investigator: Thanh Cheng, MD Hope Biosciences Stem Cell Research Foundation
Principal Investigator: Joseph Varon, MD United Memorial Medical Center
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Responsible Party: Hope Biosciences
ClinicalTrials.gov Identifier: NCT04348435    
Other Study ID Numbers: Allogeneic COVID-19 Protection
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hope Biosciences:
Coronavirus
Prevention
Immune support
stem cells
mesenchymal stem cells
adipose-derived mesenchymal stem cells