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

NCT ID: NCT04252118

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2021-12-31

Brief 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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

MSCs

Intervention Type: BIOLOGICAL

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

Conventional Control Group

Without MSCs Therapy but conventional treatment should be received.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MSCs

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovative Precision Medicine Group (IPM), Hangzhou, China.

UNKNOWN

Sponsor Role: collaborator

Huoshenshan Hospital

OTHER

Sponsor Role: collaborator

Tianjin Haihe Hospital

OTHER

Sponsor Role: collaborator

Vcanbio Cell and Gene Engineering Corp., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shenzhen Third People's Hospital

OTHER

Sponsor Role: collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Beijing 302 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fu-Sheng Wang

Head of Treatment and Research Center for Infectious Diseases, Principle Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing 302 Military Hospital of China

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Shi, MD,PhD

Role: CONTACT

shilei302@126.com

86-10-66933333

Fusheng Wang, MD,PhD

Role: CONTACT

fswang302@163.com

86-10-66933328

Facility Contacts

Lei Shi, MD, PhD

Role: primary

shilei302@126.com

86-10-66933333

Other Identifiers

2020003D

Identifier Type: -

Identifier Source: org_study_id