Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: Structured summary of a study protocol for a randomized controlled trial (Phase I/II)

Abstract

Objectives: To assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19. Trial design: This is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial. Participants: Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020. Inclusion Criteria: hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below: 1) Adults aged 18-65 years; 2) Voluntarily participate in this clinical trial and sign the "informed consent form"or have consent from a legal representative. 3) Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times/min); hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen/oxygen concentration < 300 mmHg). 4) COVID-19 featured lung lesions in chest X-ray image. Exclusion Criteria: Patients will be excluded from the study if they meet any of the following criteria. 1. Patients have received other experimental treatment for COVID-19 within the last 30 days; 2. Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit); 3. Patients with severe renal insufficiency (estimated glomerular filtration rate