Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With COVID-19

Safety and Efficiency of Mesenchymal Stem Cell in Treating Pneumonia Patients Infected With COVID-19

The SARS-CoV-2 infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. There is no confirmed antivirus therapy for people infected SARS-CoV-2, most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Mesenchymal Stem Cells (MSCs) therapy for pneumonia patients infected with SARS-CoV-2.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Biological: MSCs

Detailed Description

SARS-CoV-2 infection has become an urgent public health event in China. As of 24:00 on January 26, 2020, there are 2744 confirmed cases and 461 severe cases in China, the number is still increasing. There is currently no vaccine and no specific antiviral treatment recommended for SARS-CoV-2 infection. About 20% of the patients were severe and some died of respiratory failure or multiple organ failure. Therefore, it is urgent to find a safe and effective therapeutic approach to pneumonia patients infected with SARS-CoV-2.

In the last year, the promising features of mesenchymal stem cells (MSCs), including their regenerative properties and ability to differentiate into diverse cell lineages, have generated great interest among researchers whose work has offered intriguing perspectives on cell-based therapies for various diseases. These findings seem to highlight that the beneficial effect of MSC-based treatment could be principally due by the immunomodulation and regenerative potential of these cells. The investigators found that infusions of UC-MSC significantly improved liver function in decompensated liver cirrhosis and primary biliary cirrhosis (PBC) patients, increased the survival rate in acute-on-chronic liver failure (ACLF) patients . MSCs could significantly reduce the pathological changes of lung and inhibit the cell-mediated immune inflammatory response induced by influenza virus in animal model .

The purpose of this study is to investigate safety and efficiency of MSCs in treating pneumonia patients infected with SARS-CoV-2. This multi-center trial will recruit 20 patients. 10 patients received i.v. transfusion one round (3 times) of 3.0*10E7 cells of MSCs as the treated group, all of them received the conventional treatment. In addition, the equal 10 patients received conventional treatment were used as control. The clinical symptoms, pulmonary imaging, side effects, 28-days mortality, immunological characteristics (immune cells, inflammatory factors, etc.) will be evaluated during the 180 days follow up.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lei Shi, MD,PhD; Phone Number: 86-10-66933333; Email: shilei302@126.com
• Study Contact Backup: Name: Fusheng Wang, MD,PhD; Phone Number: 86-10-66933328; Email: fswang302@163.com

Study Locations

• China
  • Beijing, China, 100039
    • Recruiting
    • Beijing 302 Military Hospital of China
    • Contact: Lei Shi, MD, PhD; Phone Number: 86-10-66933333; Email: shilei302@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, aged at 18 years (including) -70 years old
2. Confirmed COVID-19 by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; and
3. Pneumonia that is judged by chest radiograph or computed tomography.

Exclusion Criteria:

1. Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures;
2. Patients with malignant tumor, other serious systemic diseases and psychosis;
3. Patients who are participating in other clinical trials;
4. Inability to provide informed consent or to comply with test requirements.
5. Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MSCs Treatment Group; Conventional treatment plus MSCs Participants will receive conventional treatment plus 3 times of MSCs(3.0*10E7 MSCs intravenously at Day 0, Day 3, Day 6).	Biological: MSCs; 3 times of MSCs(3.0*10E7 MSCs intravenously at Day 0, Day 3, Day 6).
No Intervention: Conventional Control Group; Without MSCs Therapy but conventional treatment should be received.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of lesion area by chest radiograph or CT	Evaluation of Pneumonia Improvement	At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21，Day 28
Side effects in the MSCs treatment group	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of mortality within 28-days	Marker for efficacy of treatment	Day 28
Improvement of Clinical symptoms including duration of fever and respiratory	Evaluation of Pneumonia Improvement	At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28
Time of nucleic acid turning negative	Marker for COVID-19	At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180
CD4+ and CD8+ T celll count	Marker of Immunological function	At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180
Alanine aminotransferase	Markers of organ function	At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180
C-reactive protein	Markers of Infection	At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180
Creatine kinase	Markers of organ function	At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180

Collaborators and Investigators

• Sponsor: Beijing 302 Hospital
• Collaborators: Fifth Affiliated Hospital, Sun Yat-Sen University; Shenzhen Third People's Hospital; Innovative Precision Medicine Group (IPM), Hangzhou, China.; Huoshenshan Hospital; Tianjin Haihe Hospital; VCANBIO Cell & Gene Engineering Corporation, Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Cell Therapy; Safety; COVID-19; Mesenchymal stem cell; Efficiency
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: 2020003D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No