Clinical trial NCT04349631: 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 Safety and Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: Coronavirus
Prevention
Immune support
stem cells
mesenchymal stem cells
adipose-derived mesenchymal stem cells
Lead sponsor: Hope Biosciences
Sponsor class: INDUSTRY
Collaborators: name: Hope Biosciences
First posted: 2020-04-16
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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. 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.

Eligibility criteria: Inclusion Criteria:

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

1. Men, and women 65 years of age or older (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.
8. 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.

1. Women who are pregnant or lactating, or those who are not pregnant but do not take effective contraceptive measures
2. Patients who are participating in other clinical trials or have intake of investigational drug within the previous 30 days;
3. Inability to provide informed consent or to comply with test requirements;
4. 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.
5. Patients who have received a stem cell treatment within one year.
6. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.
7. Patient currently or recently symptomatic for COVID-19 or anyone with COVID-19 associated symptoms within the past 30-days

Primary outcomes:
measure: Incidence of Hospitalization for COVID-19
timeFrame: Week 0 through Week 26 (End of Study)
measure: Incidence of Symptoms for COVID-19
timeFrame: Week 0 through Week 26 (End of Study)
Secondary outcomes:
measure: Absence of Upper/Lower Respiratory Infection
timeFrame: Week 0 through Week 26 (End of Study)
measure: Change From Baseline in Glucose
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Calcium
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Albumin
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Total Protein
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Sodium
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Total Carbon Dioxide
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Potassium
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Chloride
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Blood Urea Nitrogen (BUN)
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Creatinine
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Alkaline Phosphatase
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Alanine Aminotransferase
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Aspartate Aminotransferase
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Total Bilirubin
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Leukocytes
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Erythrocytes
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Hemoglobin
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Hematocrit
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Mean Corpuscular Volume
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Mean Corpuscular Hemoglobin
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Mean Corpuscular Hemoglobin Concentration
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Erythrocyte Distribution Width
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Neutrophils
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Lymphocytes
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Monocytes
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Eosinophils
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Basophils
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Platelets
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Prothrombin Time
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in International Normalized Ratio (INR)
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha)
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Interleukin-6
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Interleukin-10
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in C-Reactive Protein
timeFrame: Weeks 0, 6, 14, 26
measure: Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning
timeFrame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
measure: Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health
timeFrame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
measure: Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems
timeFrame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
measure: Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue
timeFrame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
measure: Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being
timeFrame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
measure: Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning
timeFrame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
measure: Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain
timeFrame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
measure: Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health
timeFrame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
measure: Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score
timeFrame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Other outcomes:
Locations:
city: Sugar Land
country: United States
facility: Hope Biosciences Stem Cell Research Foundation
state: Texas
Study officials:
affiliation: Hope Biosciences Stem Cell Research Foundation
name: Thanh Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: