NCT04348435

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

A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Assess Efficacy and Safety of Allogeneic HB-adMSCs to Provide Immune Support Against COVID-19.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Hope Biosciences Research Foundation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	HB-adMSCs	Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
OTHER	Placebos	Saline

Timeline

• Start date: 2020-05-14
• Primary completion: 2021-05-12
• Completion: 2021-05-12
• First posted: 2020-04-16
• Last updated: 2025-09-26
• Results posted: 2022-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study