A Phase II, Open Label, Single-Center, Clinical Trial to Assess Safety and Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease
Latest Information Update: 06 Nov 2023
At a glance
- Drugs Autologous adipose derived mesenchymal stem cells Hope Biosciences (Primary)
- Indications COVID 2019 infections
- Focus Therapeutic Use
- Sponsors Hope Biosciences
- 26 May 2021 Status changed from active, no longer recruiting to completed.
- 23 Feb 2021 Planned End Date changed from 31 Dec 2020 to 1 May 2021.
- 21 Oct 2020 Status changed from recruiting to active, no longer recruiting.
Most Recent Events
Trial Overview
Purpose
This Phase II study is a single arm, non-randomized study that is expected to enroll 75 participants that are either 50 years of age, have preexisting health conditions, or are at high-exposure risk. The study's primary objective is to determine the efficacy of HB-adMSCs to prepare the immune system so that it is better able to fight the virus, should one become infected. We anticipate that this pretreatment will limit the progression and severity of COVID-19, ultimately keeping patients out of the hospital and off of mechanical ventilation.
Primary Endpoints
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)
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)
Other Endpoints
Absence of Upper/Lower Respiratory Infection
description: Absence of upper/lower respiratory infection (with hospitalization criteria)
time_frame: Week 0 through Week 26 (End of Study)
Change From Baseline in Glucose
description: Change from baseline in level of glucose in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Calcium
description: Change from baseline in level of calcium in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Albumin
description: Change from baseline in level of albumin in the blood (g/dL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Total Protein
description: Change from baseline in level of total protein in the blood (g/dL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Sodium
description: Change from baseline in level of sodium in the blood (mmol/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Total Carbon Dioxide
description: Change from baseline in level of carbon dioxide in the blood (mmol/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Potassium
description: Change from baseline in level of potassium in the blood (mmol/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Chloride
description: Change from baseline in level of chloride in the blood (mmol/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Blood Urea Nitrogen (BUN)
description: Change from baseline in level of blood urea nitrogen (BUN) in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Creatinine
description: Change from baseline in level of creatinine in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Alkaline Phosphatase
description: Change from baseline in level of alkaline phosphatase in the blood (IU/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Alanine Aminotransferase
description: Change from baseline in level of alanine aminotransferase in the blood (IU/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Aspartate Aminotransferase
description: Change from baseline in level of aspartate aminotransferase in the blood (IU/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Total Bilirubin
description: Change from baseline in level of total bilirubin in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Leukocytes
description: Change from baseline in level of leukocytes in the blood (x 10^9/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Erythrocytes
description: Change from baseline in erythrocytes in the blood (10^12/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Hemoglobin
description: Change from baseline in level of hemoglobin in the blood (g/dL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Hematocrit
description: Change from baseline in level of hematocrit in the blood (%)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Mean Corpuscular Volume
description: Change from baseline in mean corpuscular volume in the blood (fL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Mean Corpuscular Hemoglobin
description: Change from baseline in mean corpuscular hemoglobin in the blood (pg)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Mean Corpuscular Hemoglobin Concentration
description: Change from baseline in mean corpuscular hemoglobin in the blood (g/dL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Erythrocyte Distribution Width
description: Change from baseline in erythrocyte distribution width in the blood (%)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Neutrophils
description: Change from baseline in neutrophils in the blood (%) (leukocyte differential)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Lymphocytes
description: Change from baseline in lymphocytes in the blood (%) (leukocyte differential)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Monocytes
description: Change from baseline in monocytes in the blood (%) (leukocyte differential)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Eosinophils
description: Change from baseline in eosinophils in the blood (%) (leukocyte differential)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Basophils
description: Change from baseline in basophils in the blood (%) (leukocyte differential)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Platelets
description: Change from baseline in platelets in the blood (x 10^9/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Prothrombin Time
description: Change from baseline in prothrombin time in the blood (seconds)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in International Normalized Ratio (INR)
description: Change from baseline in international normalized ratio in the blood (INR) (ratio)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha)
description: Change from baseline in tumor necrosis factor alpha (TNF-alpha) in the blood (ng/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Interleukin-6
description: Change from baseline in Interleukin-6 in the blood (ng/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Interleukin-10
description: Change from baseline in Interleukin-10 in the blood (ng/L)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in C-Reactive Protein
description: Change from baseline in C-Reactive Protein in the blood (mg/dL)
time_frame: Weeks 0, 6, 14, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning
description: Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability.
time_frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health
description: 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.
time_frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems
description: 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.
time_frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue
description: Short-form (36) Health Survey domain Average Energy/Fatigue; scored on a scale of 0-100; lower score equals more disability.
time_frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being
description: Short-form (36) Health Survey domain Average Emotional Well-Being; scored on a scale of 0-100; lower score equals more disability.
time_frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning
description: Short-form (36) Health Survey domain Average Social Functioning; scored on a scale of 0-100; lower score equals more disability.
time_frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain
description: Short-form (36) Health Survey domain Average Pain; scored on a scale of 0-100; lower score equals more disability.
time_frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health
description: Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability.
time_frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score
description: 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
time_frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26 [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | prevention | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT04349631 | Alkaline phosphatase (ALPL) | Outcome Measure |
| ALT | Outcome Measure | |
| C-reactive protein (CRP) | Outcome Measure | |
| Interleukin-10 (IL-10) | Outcome Measure | |
| Interleukin-6 (IL-6) | Outcome Measure | |
| Tumor necrosis factor alpha (TNF-alpha) | Outcome Measure |
Subjects
- Subject Type patients & volunteers
-
Number
Planned: 75
Actual: 51
- Sex male & female
- Age Group ≥ 18 years; adult
Patient 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.
Patient 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
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT04349631 | ClinicalTrials.gov: US National Institutes of Health |
| Protection-Against-COVID19 | - |
| HBCOV01 | - |
| HBCOVID01 | - |
Organisations
- Sponsors Hope Biosciences
- Affiliations Hope Biosciences
Trial Dates
-
Initiation Dates
Planned : 07 May 2020
Actual : 22 Apr 2020
-
Primary Completion Dates
Planned : 31 Dec 2020
Actual : 25 Nov 2020
-
End Dates
Planned : 01 May 2021
Actual : 25 Nov 2020
Other Details
- Design open; prospective
- Phase of Trial Phase II
- Location USA
- Focus Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| Autologous adipose derived mesenchymal stem cells Hope BiosciencesPrimary Drug | Intravenous | Infusion |
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. Biological: HB-adMSCs (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.)
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| Thanh Cheng, MD | Hope Biosciences Stem Cell Research Foundation |
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|
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| Hope Biosciences |
-
|
-
|
| Hope Biosciences Stem Cell Research Foundation |
-
|
-
|
| Sherry Diers | Sugar Land, Texas | USA |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 06 Nov 2023 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 06 Nov 2023 |
| 07 Jul 2021 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
| 26 May 2021 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 31 May 2021 |
| 23 Feb 2021 | Completion date | Planned End Date changed from 31 Dec 2020 to 1 May 2021. Updated 26 Feb 2021 |
| 21 Oct 2020 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 26 Oct 2020 |
| 28 Apr 2020 | Other trial event | Planned initiation date (estimated date for recruitment of the first subject) changed from 16 Apr 2020 to 7 May 2020. Updated 04 May 2020 |
| 23 Apr 2020 | Other trial event | According to a Hope Biosciences media release, this study is funded by the Hope Biosciences Stem Cell Research Foundation. Updated 27 Apr 2020 |
| 23 Apr 2020 | Other trial event | According to a Hope Biosciences media release, Hope Biosciences Stem Cell Research Foundation successfully completes the first 10 treatments for immune support against COVID-19. Updated 27 Apr 2020 |
| 20 Apr 2020 | Other trial event | New source identified and integrated ClinicalTrials.gov: US National Institutes of Health (NCT04349631) Updated 20 Apr 2020 |
| 14 Apr 2020 | Status change - recruiting | Status changed from planning to recruiting. Updated 20 Apr 2020 |
| 08 Apr 2020 | New trial record | New trial record Updated 08 Apr 2020 |
| 06 Apr 2020 | Other trial event | According to a Hope Biosciences media release, U.S. FDA has approved to commence Phase II stem cell clinical trial for protection against COVID-19. Updated 08 Apr 2020 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Hope Biosciences. Hope Biosciences Receives FDA Approval to Commence First Stem Cell Clinical Trial for Protection Against COVID-19. Media-Rel 2020;.
Media Release -
Hope Biosciences. Hope Biosciences Receives Second FDA Clearance for a Phase II Clinical Trial for Protection Against COVID-19. Media-Rel 2020;.
Media Release -
Hope Biosciences. Hope Biosciences Stem Cell Research Foundation Completes First Treatments for COVID-19. Media-Rel 2020;.
Media Release
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