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)

AbstractObjectivesTo assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19.Trial designThis is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial.ParticipantsTwenty 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:Adults aged 18-65 years;Voluntarily participate in this clinical trial and sign the “informed consent form” or have consent from a legal representative.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).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.Patients have received other experimental treatment for COVID-19 within the last 30 days;Patients have severe liver condition (e.g., Child Pugh score>=C or AST> 5 times of the upper limit);Patients with severe renal insufficiency (estimated glomerular filtration rate<=30mL / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;Patients who ar...
Source: Trials - Category: Research Source Type: clinical trials