Phase 2
Completed N=51
A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19
Source: ClinicalTrials.gov NCT04349631 ↗Enrolled (actual)
51
Serious AEs
5.9%
Results posted
Oct 2023
Primary outcomePrimary: Incidence of Hospitalization for COVID-19 — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Hospitalization for COVID-19 |
— | — |
| PRIMARY Incidence of Symptoms for COVID-19 |
— | — |
| SECONDARY Absence of Upper/Lower Respiratory Infection |
— | — |
| SECONDARY Change From Baseline in Glucose |
96.4; -4.1; 5.8; 6.8 | — |
| SECONDARY Change From Baseline in Calcium |
9.44; -0.03; 0.00; -0.03 | — |
| SECONDARY Change From Baseline in Albumin |
4.62; -0.10; -0.22; -0.05 | — |
| SECONDARY Change From Baseline in Total Protein |
6.89; -0.04; -0.11; 0.02 | — |
| SECONDARY Change From Baseline in Sodium |
141.0; -0.7; -1.3; -1.4 | — |
| SECONDARY Change From Baseline in Total Carbon Dioxide |
23.4; 0.9; 0.6; 0.1 | — |
| SECONDARY Change From Baseline in Potassium |
4.31; -0.21; -0.16; -0.10 | — |
| SECONDARY Change From Baseline in Chloride |
102.0; -0.7; 0.1; -0.4 | — |
| SECONDARY Change From Baseline in Blood Urea Nitrogen (BUN) |
15.0; -1.0; 0.5; -0.7 | — |
| SECONDARY Change From Baseline in Creatinine |
0.838; -0.003; -0.000; -0.013 | — |
| SECONDARY Change From Baseline in Alkaline Phosphatase |
61.9; -1.0; -2.3; 5.3 | — |
| SECONDARY Change From Baseline in Alanine Aminotransferase |
21.2; -2.0; -3.2; -1.1 | — |
| SECONDARY Change From Baseline in Aspartate Aminotransferase |
22.7; -3.3; -3.1; -0.1 | — |
| SECONDARY Change From Baseline in Total Bilirubin |
0.50; -0.03; -0.03; -0.05 | — |
| SECONDARY Change From Baseline in Leukocytes |
6.41; -0.13; 0.07; 0.01 | — |
| SECONDARY Change From Baseline in Erythrocytes |
4.610; 0.018; -0.015; 0.042 | — |
| SECONDARY Change From Baseline in Hemoglobin |
13.83; -0.02; -0.22; 0.03 | — |
| SECONDARY Change From Baseline in Hematocrit |
43.27; -0.70; -1.60; -1.06 | — |
| SECONDARY Change From Baseline in Mean Corpuscular Volume |
94.2; -2.0; -3.1; -3.2 | — |
| SECONDARY Change From Baseline in Mean Corpuscular Hemoglobin |
30.05; -0.15; -0.33; -0.17 | — |
| SECONDARY Change From Baseline in Mean Corpuscular Hemoglobin Concentration |
31.94; 0.47; 0.70; 0.88 | — |
| SECONDARY Change From Baseline in Erythrocyte Distribution Width |
14.00; -1.09; -1.14; -1.00 | — |
| SECONDARY Change From Baseline in Neutrophils |
59.2; -0.70; -0.40; -1.10 | — |
| SECONDARY Change From Baseline in Lymphocytes |
30.5; 0.27; -0.19; 0.63 | — |
| SECONDARY Change From Baseline in Monocytes |
7.3; 0.05; 0.29; 0.03 | — |
| SECONDARY Change From Baseline in Eosinophils |
2.3; 0.23; -0.02; -0.03 | — |
| SECONDARY Change From Baseline in Basophils |
0.6; 0.18; 0.29; 0.25 | — |
| SECONDARY Change From Baseline in Platelets |
268.8; -0.3; -1.9; -11.6 | — |
| SECONDARY Change From Baseline in Prothrombin Time |
11.16; -0.08; 0.20; 0.49 | — |
| SECONDARY Change From Baseline in International Normalized Ratio (INR) |
1.06; -0.01; 0.03; 0.08 | — |
| SECONDARY Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) |
1.75; 0.02; -0.12; -0.26 | — |
| SECONDARY Change From Baseline in Interleukin-6 |
2.5; 0.78; 0.59; -0.50 | — |
| SECONDARY Change From Baseline in Interleukin-10 |
6.1; 1.63; 0.83; 7.99 | — |
| SECONDARY Change From Baseline in C-Reactive Protein |
5.0; -0.26; -0.35; -0.43 | — |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning |
78.8; 0.67; 2.89; 2.09; 5.70; 4.76 | — |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health |
72.8; 0.56; 11.11; 8.72; 12.21; 10.98 | — |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems |
76.3; 7.41; 9.63; 12.40; 10.85; 11.38 | — |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue |
59.7; 5.44; 5.89; 9.07; 10.93; 11.59 | — |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being |
76.4; 2.93; 2.84; 6.60; 7.07; 6.24 | — |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning |
83.1; 4.72; 0.83; 7.85; 5.81; 8.54 | — |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain |
74.4; 6.17; 6.33; 9.42; 11.57; 9.57 | — |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health |
68.2; 2.44; 5.00; 6.16; 8.26; 8.05 | — |
| SECONDARY Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score |
4.9; -1.67; -1.24; -2.30; -1.81; -2.68 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04349631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.