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A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous 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: NCT04349631
Recruitment Status : Enrolling by invitation
First Posted : April 16, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Hope Biosciences

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease
Estimated Study Start Date : May 7, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: 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.




Primary Outcome Measures :
  1. Incidence of hospitalization for COVID-19 [ Time Frame: Week 0 through week 26 (end of study) ]
    Number of subjects that require hospitalization for COVID-19

  2. Incidence of symptoms for COVID-19 [ Time Frame: week 0 through week 26 (end of study) ]
    Number of subjects that develop symptoms 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: Weeks 0 through 26 ]
    absence of upper/lower respiratory infection by hospitalization criteria

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

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

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

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

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

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

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

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

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

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

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

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

  14. Aspartate aminotransferase [ Time Frame: Weeks 0, 6, 14, 26 ]
    clinical lab evaluation of level of aspartate aminotransferase in the blood (IU/L)

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

  16. 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)

  17. 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)

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

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

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

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

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

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

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

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

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

  27. Eos [ Time Frame: Weeks 0, 6, 14, 26 ]
    clinical lab evaluation of eosinophils in the blood (%)

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

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

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

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

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

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

  34. Immature granulocytes [ Time Frame: Weeks 0, 6, 14, 26 ]
    clinical lab evaluation of granulocytes in the blood (%)

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

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

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

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

  39. TNFalpha [ Time Frame: Weeks 0, 6, 14, 26 ]
    clinical lab evaluation of tumor necrosis factor alpha in the blood (pg/mL)

  40. Interleukin-6 [ Time Frame: Weeks 0, 6, 14, 26 ]
    clinical lab evaluation of interleukin-6 in the blood (pg/mL)

  41. Interleukin-10 [ Time Frame: Weeks 0, 6, 14, 26 ]
    clinical lab evaluation of interleukin-10 in the blood (pg/mL)

  42. C-reactive protein [ Time Frame: Weeks 0, 6, 14, 26 ]
    clinical lab evaluation of interleukin-10 in the blood (mg/L)

  43. 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.

  44. 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:

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.

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): NCT04349631


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
Investigators
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Principal Investigator: Thanh Cheng, MD Hope Biosciences Stem Cell Research Foundation
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Responsible Party: Hope Biosciences
ClinicalTrials.gov Identifier: NCT04349631    
Other Study ID Numbers: Protection Against COVID-19
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 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