MedTrace Logo

A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating Severe Novel Coronavirus Pneumonia

NCT04276987 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-09-07

No results posted yet for this study

Summary

In December 2019, a novel coronavirus infectious disease characterized by acute respiratory impairment due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) broke out in Wuhan city of Hubei province in China. So far no specific antiviral therapy can be available for patients with SARS-CoV-2 infection. Although symptomatic and supportive care, even with mechanical ventilation or extracorporeal membrane oxygenation (ECMO), are strongly recommended for severe infected individuals, those with advancing age and co-morbidities such as diabetes and heart disease remain to be at high risk for adverse outcomes. This pilot clinical trial will be performed to explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in severe patients with novel coronavirus pneumonia (NCP).

Conditions

  • Coronavirus

Interventions

BIOLOGICAL

MSCs-derived exosomes

5 times aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5).

Sponsors & Collaborators

  • Shanghai Public Health Clinical Center

    collaborator OTHER_GOV

  • Wuhan Jinyintan Hospital, Wuhan, China

    collaborator UNKNOWN

  • Shanghai AbelZeta Ltd.

    collaborator INDUSTRY

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Jie-ming Qu, MD.,PhD. · Ruijin Hospital, Medical School of Shanghai Jiaotong University Shanghai, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2020-05-31
Completion
2020-07-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276987 on ClinicalTrials.gov