Skip to main content
OpenTrials
Completed

NCT Number: NCT04349631

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, 77478, United States

About this study

This is a Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 51 patients were enrolled. All patients have previously banked their own mesenchymal stem cells at Hope Biosciences. Eligible participants are either 65 years of age or older, have preexisting conditions, or are at high exposure risk of contracting COVID-19. The primary objective of this study is to provide immune support against COVID-19, measured by 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet the criteria for 1,2, OR 3, AND 4-7 to be eligible.

  • Men, and women 65 years of age or older (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.
  • Agrees to conformational testing for SARS-CoV-2 before end of study.

Exclusion criteria

Subjects must not have any of the following criteria to be eligible.

  • 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.
  • Patient currently or recently symptomatic for COVID-19 or anyone with COVID-19 associated symptoms within the past 30-days

Treatment and study plan

HB-adMSCs

Biological

Five IV infusions 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 outcomes

  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 outcomes

  1. Absence of Upper/Lower Respiratory Infection

    Time frame: Week 0 through Week 26 (End of Study)

    Absence of upper/lower respiratory infection (with hospitalization criteria)

  2. Change From Baseline in Glucose

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of glucose in the blood (mg/dL)

  3. Change From Baseline in Calcium

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of calcium in the blood (mg/dL)

  4. Change From Baseline in Albumin

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of albumin in the blood (g/dL)

  5. Change From Baseline in Total Protein

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of total protein in the blood (g/dL)

  6. Change From Baseline in Sodium

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of sodium in the blood (mmol/L)

  7. Change From Baseline in Total Carbon Dioxide

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of carbon dioxide in the blood (mmol/L)

  8. Change From Baseline in Potassium

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of potassium in the blood (mmol/L)

  9. Change From Baseline in Chloride

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of chloride in the blood (mmol/L)

  10. Change From Baseline in Blood Urea Nitrogen (BUN)

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of blood urea nitrogen (BUN) in the blood (mg/dL)

  11. Change From Baseline in Creatinine

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of creatinine in the blood (mg/dL)

  12. Change From Baseline in Alkaline Phosphatase

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of alkaline phosphatase in the blood (IU/L)

  13. Change From Baseline in Alanine Aminotransferase

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of alanine aminotransferase in the blood (IU/L)

  14. Change From Baseline in Aspartate Aminotransferase

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of aspartate aminotransferase in the blood (IU/L)

  15. Change From Baseline in Total Bilirubin

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of total bilirubin in the blood (mg/dL)

  16. Change From Baseline in Leukocytes

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of leukocytes in the blood (x 10^9/L)

  17. Change From Baseline in Erythrocytes

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in erythrocytes in the blood (10^12/L)

  18. Change From Baseline in Hemoglobin

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of hemoglobin in the blood (g/dL)

  19. Change From Baseline in Hematocrit

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in level of hematocrit in the blood (%)

  20. Change From Baseline in Mean Corpuscular Volume

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in mean corpuscular volume in the blood (fL)

  21. Change From Baseline in Mean Corpuscular Hemoglobin

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in mean corpuscular hemoglobin in the blood (pg)

  22. Change From Baseline in Mean Corpuscular Hemoglobin Concentration

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in mean corpuscular hemoglobin in the blood (g/dL)

  23. Change From Baseline in Erythrocyte Distribution Width

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in erythrocyte distribution width in the blood (%)

  24. Change From Baseline in Neutrophils

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in neutrophils in the blood (%) (leukocyte differential)

  25. Change From Baseline in Lymphocytes

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in lymphocytes in the blood (%) (leukocyte differential)

  26. Change From Baseline in Monocytes

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in monocytes in the blood (%) (leukocyte differential)

  27. Change From Baseline in Eosinophils

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in eosinophils in the blood (%) (leukocyte differential)

  28. Change From Baseline in Basophils

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in basophils in the blood (%) (leukocyte differential)

  29. Change From Baseline in Platelets

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in platelets in the blood (x 10^9/L)

  30. Change From Baseline in Prothrombin Time

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in prothrombin time in the blood (seconds)

  31. Change From Baseline in International Normalized Ratio (INR)

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in international normalized ratio in the blood (INR) (ratio)

  32. Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha)

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in tumor necrosis factor alpha (TNF-alpha) in the blood (ng/L)

  33. Change From Baseline in Interleukin-6

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in Interleukin-6 in the blood (ng/L)

  34. Change From Baseline in Interleukin-10

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in Interleukin-10 in the blood (ng/L)

  35. Change From Baseline in C-Reactive Protein

    Time frame: Weeks 0, 6, 14, 26

    Change from baseline in C-Reactive Protein in the blood (mg/dL)

  36. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning

    Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26

    Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability.

  37. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health

    Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26

    Short-form (36) Health Survey domain Average Role Limitations due to Physical Health; scored on a scale of 0-100; lower score equals more disability.

  38. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems

    Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26

    Short-form (36) Health Survey domain Average Role Limitations due to Emotional Problems; scored on a scale of 0-100; lower score equals more disability.

  39. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue

    Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26

    Short-form (36) Health Survey domain Average Energy/Fatigue; scored on a scale of 0-100; lower score equals more disability.

  40. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being

    Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26

    Short-form (36) Health Survey domain Average Emotional Well-Being; scored on a scale of 0-100; lower score equals more disability.

  41. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning

    Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26

    Short-form (36) Health Survey domain Average Social Functioning; scored on a scale of 0-100; lower score equals more disability.

  42. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain

    Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26

    Short-form (36) Health Survey domain Average Pain; scored on a scale of 0-100; lower score equals more disability.

  43. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health

    Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26

    Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability.

  44. Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score

    Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26

    Depression module; scores DSM-IV criteria to monitor severity of depression through 9 total questions; minimum score of 0, maximum score of 27, each question ranges from scores 0-3; higher scores mean worse outcome

Sponsors and collaborators

Lead sponsor

Hope Biosciences Research Foundation

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2020
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.