Safety and Tolerance of Umbilical Cord Mesenchymal Stem Cells in Patients With Acute Respiratory Distress Syndrome

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAsia Cell Therapeutics (Shanghai) Co., Ltd.

About this trial

The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with Mild to Moderate Acute Respiratory Distress Syndrome (ARDS), and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with Mild to Moderate Acute Respiratory Distress Syndrome (ARDS).

Participants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells. Each subject will receive three infusions.

Eligibility criteria

Qualifiers

18-75 years old (including the threshold), male or female

A definite diagnosis of mild to moderate acute respiratory distress syndrome (ARDS) (according to the ARDS Berlin definition and diagnostic criteria)

ARDS onset ≤ 5 days

100 mmHg < PaO2/FiO2 ≤ 300 mmHg

Disqualifiers

Hypersensitivity to known components of the drug (the main component of this product is human umbilical cord mesenchymal stem cells, excipients include dimethyl sulfoxide, human albumin, compound electrolyte injection), the presence of a history of allergy to gentamicin or other history of severe allergy

Patients requiring treatment for any malignancy within 2 years prior to administration (except non-melanoma skin cancer)

Lung transplant patients

Patients with malignant haematological diseases

Trial design

Treatments tested in this trial

  • Human Umbilical Cord Mesenchymal Stem Cells

Treatment groups

9 Participants
are divided into 1 treatment group

Locations

This trial has no locations