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Clinical Study for Human Menstrual Blood-Derived Stem Cells in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19)

Clinical Study for Human Menstrual Blood-derived Stem Cells in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029606
Enrollment
Unknown
Registered
2020-02-07
Start date
2020-01-25
Completion date
Unknown
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

experimental group A:Conventional treatment followed by Intravenous infusion of Human Menstrual Blood-derived Stem Cells preparations
control gorup A:Conventional treatment
Experimental Group B1:Artificial liver therapy+conventional treatment
Experimental Group B2:Artificial liver therapy followed by Intravenous infusion of Human Menstrual Blood-derived Stem Cells preparations+conventional treatment
Control Gorup A:Conventional treatment

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as novel coronavirus pneumonia (NCP) Patient: 1) Basis of diagnostic criteria: "Notice on Printing and Distributing Pneumonia Diagnosis and Treatment Plan for New Coronavirus Infection (Trial Implementation Fourth Edition)" (National Health Office Medical Letter C2020377) 2019-nCoV diagnosis of pneumonia: (1) Epidemiological history: A. Travel history or residence history in Wuhan area or other areas with continuous local case transmission within 14 days before onset; B. Contact history within 14 days before onset Patients with fever or respiratory symptoms from Wuhan City or other areas where local case transmission is ongoing; C. Aggregative onset or epidemiological association with new coronavirus infection. (2) Clinical manifestations: A. fever; B. imaging characteristics of pneumonia: multiple small patchy shadows and interstitial changes in the early stage, which are obvious in the extrapulmonary zone, and then develop into multiple ground glass infiltrates and infiltrates, which are severe Patients may have pulmonary consolidation, and pleural effusion is rare; C. The total number of white blood cells is normal or reduced in the early stage of onset, or the lymphocyte count is reduced. (3) Any one of the epidemiological history meets any two of the clinical manifestations as suspected cases, and those who have one of the following pathogenic evidence are confirmed cases: A. A new type of real-time fluorescence RT-PCR test for respiratory specimens or blood specimen Coronavirus-positive nucleic acid; B. Sequencing of viral genes in respiratory specimens or blood specimens, highly homologous to known new coronaviruses. (4) It is severe if it meets any of the following: A. Respiratory distress, RR > 30 beats / min; B. In resting state, means oxygen saturation < 93%; C. Arterial partial pressure of oxygen (PaO2) / oxygen Concentration (FiO2) <= 300mmHg (lmmHg = 0.133kPa). (5) It is critical if it meets any of the following: 1) respiratory failure occurs and requires mechanical ventilation; 2) shock occurs; 3) combined organ failure requires ICU monitoring and treatment 2. The patient or legal donor agrees to participate in the study and signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. There are comorbidities that affect the judgment of the efficacy, such as those with malignant tumors or long-term immunosuppressants; 3. The investigator believes that the patient has other conditions that are not suitable for enrollment; 4. Allergic to dimethyl sulfoxide (DMSO), dextran 40 or human albumin; 5. Contraindicated signs of artificial liver therapy

Design outcomes

Secondary

MeasureTime frame
Improvement rate in patients;Incidence of shock;Incidence of multiple organ failure;Days in hospital, days in ICU;Non-invasive ventilation modes and parameters;Intubation-assisted ventilation modes and parameters;Extracorporeal membrane oxygenation patterns and parameters;

Primary

MeasureTime frame
Mortality in patients;

Countries

China

Contacts

Public ContactLanjuan Li /Xiaowei Xu/Charile Xiang

The First Affiliated Hospital, College of Medicine, Zhejiang University

ljli@zju.edu.cn+86 0571-87236426

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026