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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04252118
• Other study ID #: 2020003D
• Status: Recruiting
• Phase: Phase 1
• Start date: January 27, 2020
• Est. completion date: December 2021

Study information

• Verified date: April 2020
• Source: Beijing 302 Hospital
• Contact: Lei Shi, MD,PhD
• Phone: 86-10-66933333
• Email: shilei302[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

Biological:
• MSCs
3 times of MSCs(3.0*10E7 MSCs intravenously at Day 0, Day 3, Day 6).

Locations

Country	Name	City	State
China	Beijing 302 Military Hospital of China	Beijing

Sponsors (7)

Lead Sponsor	Collaborator
Beijing 302 Hospital	Fifth Affiliated Hospital, Sun Yat-Sen University, Huoshenshan Hospital, Innovative Precision Medicine Group (IPM), Hangzhou, China., Shenzhen Third People's Hospital, Tianjin Haihe Hospital, VCANBIO CELL & GENE ENGINEERING CORP.,LTD, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Rate of mortality within 28-days	Marker for efficacy of treatment	Day 28
Secondary	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
Secondary	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
Secondary	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
Secondary	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