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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
Sponsor: Ruijin Hospital
Summary
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of Menstrual blood-derived Mesenchymal Stem Cells (SC01009) injection for the treatment of severe pneumonia caused by viruses. The purpose of the study is to assess the safety and efficacy of SC01009 injection in combination with standard treatment in patients with severe pneumonia caused by viruses. Viral pneumonia refers to acute inflammation of the lung parenchyma and/or interstitium caused by viral infections, which often leads to varying degrees of hypoxia and infection symptoms in the body, typically manifesting as fever, cough, wheezing, shortness of breath, and moist rales in the lungs, along with abnormalities in chest imaging \[such as X-rays, computed tomography (CT), etc.\]. Viral severe pneumonia is aggressive in onset, initially presenting with fever, cough, and rhinorrhea; it then rapidly progresses to severe toxic symptoms, with respiratory manifestations including cough and dyspnea, producing white mucoid sputum, purulent sputum, or pink frothy sputum. Severely ill patients are often in a critical state of life, endangering the patient's circulatory system and being in a state of respiratory failure requiring ventilator support. Active treatment of viral severe pneumonia, with appropriate measures, can lead to complete recovery of pulmonary function. If respiratory failure or poor circulatory function occurs and ultimately cannot be corrected, the prognosis is poor. Viral severe pneumonia follows clinical pathways (antiviral treatment guidelines and antiviral drug instructions) for antiviral treatment and appropriate adjunctive therapy. Mesenchymal stem cells (MSCs) are a type of multipotent stem cell with the potential for self-renewal and differentiation, characterized by self-renewal, multilineage differentiation, low immunogenicity, and paracrine functions, capable of homing to damaged areas, promoting epithelial tissue repair, suppressing inflammation, and inhibiting abnormal proliferation of fibroblasts. SC01009 injection is a cellular therapy product developed by Zhejiang Shengchuang Precision Medical Technology Co., Ltd., with its active ingredient being Menstrual blood-derived Mesenchymal Stem Cells (Men-MSCs). Men-MSCs are derived from allogeneic endometrial tissue of women, and preclinical studies have shown that SC01009 is safe and effective in animals, supporting further clinical development.
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Uterine Blood Mesenchymal Stem Cells (SC01009) Injection for the Treatment of Severe Pneumonia Caused by Viruses
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-01-20
Completion Date
2028-06-30
Last Updated
2024-12-27
Healthy Volunteers
No
Interventions
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.
Locations (1)
Ruijin Hospital affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China