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

NCT05689008 | Unknown Phase 3

• 1 other identifier: DFSC-2023(CR)-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesenchymal Stem Cell; COVID-19 Pneumonia

Keywords

umbilical cord mesenchymal stem cells; covid-19 pneumonia; refractory hypoxia

Outcome Measures

Primary Outcomes (1)

• Oxygenation index

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

  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.

Study Arms (2)

control

NO INTERVENTION

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.

UC-MSCs treatment

EXPERIMENTAL

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

Biological: UC-MSCs treatment

Interventions

UC-MSCs treatment BIOLOGICAL

Participants will receive two doses of UC-MSCs treatment, each dose will contain 1\*10\^6 cells/kg suspended in 100 ml albumin solution.

UC-MSCs treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• kg/m2≤body mass index(BMI)≤30 kg/m2.
• Volunteer to participate in this clinical study and sign the written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai East Hospital: lead
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

Shanghai East Hospital, Shanghai Tongji University

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhongmin Liu, Dr.

  Shanghai East Hospital

  STUDY CHAIR

Central Study Contacts

Qiang Li, Dr.

CONTACT

86-021-38804518; lqressh@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 18, 2023
• Study Start: January 10, 2023
• Primary Completion: March 31, 2023
• Study Completion: July 30, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)