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Open-label, observational study of human umbilical cord derived mesenchymal stem cells in the treatment of severe and critical patients with novel coronavirus pneumonia (COVID-19)

Open-label, observational study of human umbilical cord derived mesenchymal stem cells in the treatment of severe and critical COVID-1

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030866
Enrollment
Unknown
Registered
2020-03-16
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-03-16

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

MSC group:Intravenous infusion of MSC based on conventional treatments

Sponsors

The First Hospital of Changsha
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as severe or critical COVID-19; or patients who have turned negative for viral nucleic acid detection but still have the following severe or critical manifestations: According to the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Version 6)" promulgated by the National Health Commission, any of the following is confirmed to be diagnosed as severe COVID-19: 1) shortness of breath, RR >=30 times / minute; 2) in a resting state , Oxygen saturation<=93%; 3) arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300mmHg (1mmHg = 0.133kPa). The diagnosis of critical COVID-19 is consistent with 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. Informed consent, voluntary participation and signing of informed consent by patients (or entrusted agents).

Exclusion criteria

Exclusion criteria: (1) Past medical history of pulmonary embolism; (2) Patients infected with human immunodeficiency virus (HIV); (3) Patients with malignant tumors: Patients with cervical carcinoma in situ, skin non metastatic squamous or basal cell carcinoma after complete treatment are excluded; (4) pregnant and lactating women; (5) Other situations that the clinician considers unsuitable.

Design outcomes

Primary

MeasureTime frame
Oxygenation index (arterial oxygen partial pressure (PaO2) / oxygen concentration (FiO2));Conversion rate from serious to critical patients;Conversion rate and conversion time from critical to serious patients;Mortality in serious and critical patients;

Secondary

MeasureTime frame
Low-dose spiral CT of the lung (in special cases, the investigator decides whether to use other imaging tests based on the actual situation of the patient);Peak flow meter;COVID-19 nucleic acid detection;Peripheral blood lymphocyte subsets (total T cells, CD4 + T cells, CD8 + T cells, B cells, NK cells, etc.);Cytokine detection (IL-1beta, IL-2, IL-6, IL-10, TNFalpha, etc.);Sequential organ failure assessment;APACHE II score;Acute lung injury score;Blood routine;C-reactive protein;liver and kidney function;electrolyte;myocardial enzymes;procalcitonin;coagulation function;D-dimer;arterial blood gas analysis;Respiratory function support types and parameters;

Countries

China

Contacts

Public ContactXie yuanlin

The First Hospital of Changsha

1286779459@qq.com+86 13975137399

Outcome results

None listed

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