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)

Trials
Qingsong YeYan He

Abstract

To assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19. This is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial. Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020. 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. 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 insufficie...Continue Reading

Citations

Oct 25, 2020·Cell Proliferation·Zhongwen LiJie Hao
Sep 16, 2020·European Journal of Pharmacology·Chuan-Feng TangLing-Dong Kong
Mar 3, 2021·Stem Cell Research & Therapy·Rodrigo N RiedelJulieta L Maymó
Apr 4, 2021·International Journal of Molecular Sciences·Jon LuzuriagaGaskon Ibarretxe
Jul 3, 2021·International Journal of Molecular Sciences·Sarah Hani ShoushrahEdda Tobiasch

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