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UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients With Refractory Hypoxia

Primary Purpose

Mesenchymal Stem Cell, COVID-19 Pneumonia

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
UC-MSCs treatment
Sponsored by
Shanghai East Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesenchymal Stem Cell focused on measuring umbilical cord mesenchymal stem cells, covid-19 pneumonia, refractory hypoxia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The age ranges from 18 to85 (inclusive), regardless of gender. Patients who still have refractory hypoxia after sufficient standard treatment for severe and critical COVID-19 pneumonia following the suggestion of the Chinese diagnostic criteria for COVID-19 pneumonia in the Diagnosis and Treatment Plan for COVID-19 Pneumonia (Tentative tenth Edition). 20kg/m2≤body mass index(BMI)≤30 kg/m2. Volunteer to participate in this clinical study and sign the written informed consent Exclusion Criteria: Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. T lymphocyte abnormality (allogeneic may be considered, depending on clinical opinion), HIV positive. Highly allergic or have a history of severe allergy, especially Interleukin-2 allergy. Pregnant and lactating women. Patients with severe autoimmune disease history; Allergies to all biological reagents in this treatment, such as Interleukin-2. Patients with serious complications, including chronic cardiac insufficiency (NYHA cardiac function grading assessment of cardiac function grade III - IV), chronic renal insufficiency (CKD stage 3 and above); Chronic liver insufficiency (Child-Pugh score>7); Patients with malignant tumors. Patients with pulmonary embolism or acute coronary syndrome. Patients with severe organ dysfunction caused by other diseases. There are other situations that the researcher thinks are not suitable to participate in this clinical study

Sites / Locations

  • Shanghai East Hospital, Shanghai Tongji UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

UC-MSCs treatment

Arm Description

Participants will receive standard therapy, including oxygen therapy,glucocorticoid and other antiinflammatory drugs and supportive treatments according the ninth edition of Chinese guidelines for the treatment of COVID-19 infection.

Participants will receive two doses of UC-MSCs instillation at the first and fourth day after the assignment on the basis of standard treatment.

Outcomes

Primary Outcome Measures

Oxygenation index
Oxygenation index is the artery partial pressure of oxygen divided by the concentration of inhaled oxygen.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2023
Last Updated
January 17, 2023
Sponsor
Shanghai East Hospital
Collaborators
Sir Run Run Shaw Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05689008
Brief Title
UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients With Refractory Hypoxia
Official Title
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe and Critical COVID-19 With Refractory Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital
Collaborators
Sir Run Run Shaw Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this randomized, controlled, open-labeled interventional clinical trial is to test the efficacy and safety of umbilical cord mesenchymal stem cells (UC- MSCs) in the treatment of severe and critical COVID-19 patients with refractory hypoxia even after sufficient standard treatment according to the tenth edition of Chinese guidelines for COVID-19 infection. The main questions it aims to answer are: 1. The efficacy of UC-MSCs in the treatment of severe and critical COVID-19 patients with refractory hypoxia. 2. The safety of UC-MSCs in the treatment of severe and critical COVID-19 patients. 3. The potential immune mechanisms of UC- MSCs in the treatment of severe and critical COVID-19 patients. Participants will receive standard therapy, or the UC-MSCs treatment. For the standard treatment, it will be conducted according the 10th edition of Chinese guidelines for severe or critical COVID-19 infection. For UC-MSCs treatment, participants will be given UC-MSCs instillation at the first and fourth day after assignment. Blood examples will be taken at indicated time for arterial blood gas analysis and other tests. And participants should also objectively report their symptoms change and other information related to the treatment as listed the research protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Stem Cell, COVID-19 Pneumonia
Keywords
umbilical cord mesenchymal stem cells, covid-19 pneumonia, refractory hypoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
Participants will receive standard therapy, including oxygen therapy,glucocorticoid and other antiinflammatory drugs and supportive treatments according the ninth edition of Chinese guidelines for the treatment of COVID-19 infection.
Arm Title
UC-MSCs treatment
Arm Type
Experimental
Arm Description
Participants will receive two doses of UC-MSCs instillation at the first and fourth day after the assignment on the basis of standard treatment.
Intervention Type
Biological
Intervention Name(s)
UC-MSCs treatment
Intervention Description
Participants will receive two doses of UC-MSCs treatment, each dose will contain 1*10^6 cells/kg suspended in 100 ml albumin solution.
Primary Outcome Measure Information:
Title
Oxygenation index
Description
Oxygenation index is the artery partial pressure of oxygen divided by the concentration of inhaled oxygen.
Time Frame
Change from baseline Oxygenation index (PaO2/FiO2) at 1,3,7,14,28 (or before the day of discharge if participants discharge within 28 days) days after the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The age ranges from 18 to85 (inclusive), regardless of gender. Patients who still have refractory hypoxia after sufficient standard treatment for severe and critical COVID-19 pneumonia following the suggestion of the Chinese diagnostic criteria for COVID-19 pneumonia in the Diagnosis and Treatment Plan for COVID-19 Pneumonia (Tentative tenth Edition). 20kg/m2≤body mass index(BMI)≤30 kg/m2. Volunteer to participate in this clinical study and sign the written informed consent Exclusion Criteria: Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. T lymphocyte abnormality (allogeneic may be considered, depending on clinical opinion), HIV positive. Highly allergic or have a history of severe allergy, especially Interleukin-2 allergy. Pregnant and lactating women. Patients with severe autoimmune disease history; Allergies to all biological reagents in this treatment, such as Interleukin-2. Patients with serious complications, including chronic cardiac insufficiency (NYHA cardiac function grading assessment of cardiac function grade III - IV), chronic renal insufficiency (CKD stage 3 and above); Chronic liver insufficiency (Child-Pugh score>7); Patients with malignant tumors. Patients with pulmonary embolism or acute coronary syndrome. Patients with severe organ dysfunction caused by other diseases. There are other situations that the researcher thinks are not suitable to participate in this clinical study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Li, Dr.
Phone
86-021-38804518
Email
lqressh@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongmin Liu, Dr.
Organizational Affiliation
Shanghai East Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai East Hospital, Shanghai Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongmin Liu, Dr.
Phone
+86-021-38804518
Email
liu.zhongmin@tongji.edu.cn
First Name & Middle Initial & Last Name & Degree
Qiang Li, Dr.
First Name & Middle Initial & Last Name & Degree
Yi Sun, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients With Refractory Hypoxia

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