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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
53
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, United States
Number of Participants That Were Hospitalized Due to COVID-19 Symptoms
Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study.
Time frame: Week 0 through Week 26 (End of Study)
Number of Participants That Had Symptoms Associated With COVID-19
Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough, etc.
Time frame: Week 0 through Week 26 (End of Study)
Leukocyte Differential Count
Change from baseline in Leukocyte Differential Count
Time frame: Week 0 to Week 26 (End of Study)
C Reactive Protein
Change from baseline in C Reactive Protein
Time frame: Week 0 through Week 26 (End of Study)
Tumor Necrosis Factor - Alpha
Change from baseline in TNF alpha
Time frame: Week 0 through Week 26 (End of Study)
Interleukin 6
Change from baseline in IL-6
Time frame: Week 0 through Week 26 (End of Study)
Interleukin 10
Change from baseline in IL-10
Time frame: Week 0 through Week 26 (End of Study)
Short Form-36 (SF-36)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 0 to Week 26 (End of Study)
Patient Health Questionnaire (PHQ-9) Scores
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.
Time frame: Week 0 to Week 26 (End of Study)