60
Participants
Start Date
January 20, 2025
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2028
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 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.
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."
RECRUITING
Ruijin Hospital affiliated to Shanghai Jiao Tong University, Shanghai
Shulan (Hangzhou) Hospital
OTHER
Shulan(Quzhou) Hospital
UNKNOWN
West China Hospital
OTHER
Zhejiang University
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Shanghai Zhongshan Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Henan Provincial People's Hospital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Ruijin Hospital
OTHER