CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
UC-MSCs +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04288102
NCT04288102Phase 2Completed
CompareCT.gov

A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Severe COVID-19 Patients

Beijing 302 Hospital·interventional·Posted Feb 28, 2020·Updated Aug 19, 2020

In Brief

A Phase 2 clinical trial evaluating UC-MSCs and Saline containing 1% Human serum albumin（solution without UC-MSCs） for Corona Virus Disease 2019(COVID-19). Completed, enrolled 100 participants across 3 sites.

Detailed Summary

COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Cellular therapy, using mesenchymal stem cells has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. This clinical trial is to inspect the safety and efficiency of mesenchymal stem cells (MSCs) therapy for severe COVID-19.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCorona Virus Disease 2019(COVID-19)
CountriesChina
CollaboratorsHuoshenshan Hospital, Maternal and Child Health Hospital of Hubei Province, The General Hospital of Central Theater Command, Vcanbio Cell and Gene Engineering Corp., Ltd.

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 28, 2020
Enrollment StartMar 5, 2020
Primary CompletionMay 12, 2020
Study CompletionJul 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.3 years ago

Interventions

UC-MSCsbiological

3 does of UC-MSCs(4.0\*10E7 cells per time) intravenously at Day 0, Day 3, Day 6.

Saline containing 1% Human serum albumin（solution without UC-MSCs）biological

3 does of placebo（intravenously at Day 0, Day 3, Day 6）