A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19.

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Biological: HB-adMSCs; Other: Placebos

• Registration Number: NCT04348435
• Lead Sponsor: Hope Biosciences Stem Cell Research Foundation

Brief Summary

Hope Biosciences is conducting a research study of an investigational product called allogeneic 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, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 100 patients will be enrolled. Eligible participants are at high or very 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 subjects that develop symptoms of COVID-19. 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.

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Study Start: 2020-05-14
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-12
• Results First Submitted: 2022-09-14
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Results First Posted: 2022-11-17
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Men, and women 18 years of age or older
• Participant works in a capacity that is characterized as high-risk or very high-risk
• High-Risk Exposure jobs are those with high potential for exposure to known or suspected sources of COVID-19.
• First responders, health care delivery and support staff (e.g., law enforcement, fire fighters, paramedics, doctors, nurses, and other hospital staff who must enter patients' rooms) exposed to individuals potentially having COVID-19.
• Mortuary workers involved in preparing (e.g., for burial or cremation) the bodies of people who are known to have, or suspected of having, COVID-19 at the time of their death
• Very High-Risk Exposure jobs are those with high potential for exposure to known or suspected sources of COVID-19 during specific medical, postmortem or laboratory procedures.
• Health care workers (e.g., doctors, nurses, dentists, paramedics, emergency medical technicians) performing aerosol-generating procedures (e.g., intubation, cough induction procedures, bronchoscopies, some dental procedures and exams or invasive specimen collection) on known or suspected COVID-19 patients.
• Health care or laboratory personnel collecting or handling specimens from known or suspected COVID-19 patients (e.g., manipulating cultures from known or suspected COVID-19 patients).
• Morgue workers performing autopsies, which generally involve aerosol-generating procedures, on the bodies of people who are known to have, or suspected of having, COVID-19 at the time of their death
• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allogeneic HB-adMSCs 200MM	HB-adMSCs	Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
Placebo	Placebos	Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Infusions will occur at weeks 0, 2, 6, 10, and 14.
Allogeneic HB-adMSCs 100MM	HB-adMSCs	Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
Allogeneic HB-adMSCs 50MM	HB-adMSCs	Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Had Symptoms Associated With COVID-19	Week 0 through Week 26 (End of Study)	Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough, etc.
Number of Participants That Were Hospitalized Due to COVID-19 Symptoms	Week 0 through Week 26 (End of Study)	Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study.

Secondary Outcome Measures

Name	Time	Method
Tumor Necrosis Factor - Alpha	Week 0 through Week 26 (End of Study)	Change from baseline in TNF alpha
Interleukin 6	Week 0 through Week 26 (End of Study)	Change from baseline in IL-6
Short Form-36 (SF-36)	Week 0 to Week 26 (End of Study)	The Short Form-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores (including Energy/Fatigue scores, Social Functioning, role limitations due to Physical Health, General Health, Physical Functioning, Pain, Emotional Well-Being, and Emotional Problems) which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Leukocyte Differential Count	Week 0 to Week 26 (End of Study)	Change from baseline in Leukocyte Differential Count
C Reactive Protein	Week 0 through Week 26 (End of Study)	Change from baseline in C Reactive Protein
Interleukin 10	Week 0 through Week 26 (End of Study)	Change from baseline in IL-10
Patient Health Questionnaire (PHQ-9) Scores	Week 0 to Week 26 (End of Study)	The study used PHQ-9 as a depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day) to monitor the severity of depression.

Trial Locations

Locations (1)

Hope Biosciences Stem Cell Research Foundation; 🇺🇸 Sugar Land, Texas, United States