A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Uterine Blood Mesenchymal Stem Cells Injection for the Treatment of Severe Pneumonia Caused by Viruses

PHASE1RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 20, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2028

Conditions
Severe Viral Pneumonia(Not Include COVID-19)
Interventions
DRUG

Placebo

The Menstrual blood derived mesenchymal stem cells(Men-MSCs)Placebo is administered via intravenous infusion, divided into 3 separate infusions, conducted on alternate days (i.e., Day 1, Day 3, and Day 5).The placebo must be thawed, and 3 vials of placebo must be diluted into 500ml of compound electrolyte injection solution. The medication is administered via intravenous infusion, starting with a slow drip for the first 15 minutes (30-40 drops per minute), and completed within 120 minutes to ensure cell viability. During the infusion process, the infusion bag can be gently shaken appropriately to ensure even suspension of the cells.

DRUG

Drug therapy

The Menstrual blood derived mesenchymal stem cells(Men-MSCs) injection (SC01009) is administered via intravenous infusion, with a total dose of 9×10\^7 cells, divided into 3 separate infusions, conducted on alternate days (i.e., Day 1, Day 3, and Day 5), with each infusion consisting of 3×10\^7 cells.Before the infusion, SC01009 injection must be thawed, and 3 vials of SC01009 must be diluted into 500ml of compound electrolyte injection solution. The medication is administered via intravenous infusion, starting with a slow drip for the first 15 minutes (30-40 drops per minute), and completed within 120 minutes to ensure cell viability. During the infusion process, the infusion bag can be gently shaken appropriately to ensure even suspension of the cells.

OTHER

Standard Treatment

"Anti-infective and anti-inflammatory drugs: For hospitalized patients with CAP, it is recommended to use β-lactams alone or in combination with doxycycline, minocycline, macrolides, or respiratory quinolones alone.~Corticosteroids: For patients with septic shock, hydrocortisone hemisuccinate 200 mg/day is recommended. The medication should be discontinued promptly after the correction of septic shock, and the duration of use should generally not exceed 7 days.~Antiviral drugs: Oseltamivir, acyclovir, etc.~Antipyretic drugs for those with high fever: such as aspirin, acetaminophen, indomethacin, sulindac, naproxen, etc.~Cough and expectorant drugs for cough and phlegm: ambroxol hydrochloride, acetylcysteine tablets, bromhexine, nacetylethylenediamine, pentedonate, etc.~Low molecular weight heparin: For elderly hospitalized CAP patients, the risk of deep vein thrombosis should be assessed, and low molecular weight heparin should be applied for prevention when necessary."

Trial Locations (1)

Unknown

RECRUITING

Ruijin Hospital affiliated to Shanghai Jiao Tong University, Shanghai

All Listed Sponsors
collaborator

Shulan (Hangzhou) Hospital

OTHER

collaborator

Shulan(Quzhou) Hospital

UNKNOWN

collaborator

West China Hospital

OTHER

collaborator

Zhejiang University

OTHER

collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

collaborator

Shanghai Zhongshan Hospital

OTHER

collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

collaborator

Henan Provincial People's Hospital

OTHER

collaborator

The First Affiliated Hospital of Nanchang University

OTHER

lead

Ruijin Hospital

OTHER