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

COVID-19 Pneumonia Clinical Trial

Official title:

Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe and Critical COVID-19 With Refractory Hypoxia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689008
• Other study ID #: DFSC-2023(CR)-01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: January 2023
• Source: Shanghai East Hospital
• Contact: Qiang Li, Dr.
• Phone: 86-021-38804518
• Email: lqressh[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Hypoxia
• Mesenchymal Stem Cell
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
China	Shanghai East Hospital, Shanghai Tongji University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai East Hospital	Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.