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The safety and effect of human umbilical cord mesenchymal stem cells for the treatment of sepsis induced by pneumonia

The safety and effect of human umbilical cord mesenchymal stem cells for the treatment of sepsis induced by pneumonia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050544
Enrollment
Unknown
Registered
2021-08-28
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

sepsis

Interventions

control group:Human umbilical cord mesenchymal stem cells transplantation
Experimental group:human umbilical cord mesenchymal stem cells transplantation

Sponsors

Shanghai East Hospital (East Hospital Affiliated to Tongji University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Those who sign the informed consent form, the patients and their families have good compliance; 2. Inpatients aged 18 to 65 years (including both ends), male or female; 3. The diagnostic criteria are: according to the 2016 Sepsis 3.0 diagnostic criteria, namely infection and continuous sequential organ failure score (SOFA score) >= 2 points; 4. Survival time > 7 days; 5. The SOFA score of the patient is between 6-15.

Exclusion criteria

Exclusion criteria: 1. The patient's expected survival period is less than 7 days due to the presence of uncorrectable diseases, such as advanced tumors or other advanced diseases; 2. The patient is in a predictable moribund state; 3. HIV infection combined with the latest CD4 cell count <=50/mm3; 4. History of bone marrow, lung, liver, pancreas or small intestine transplantation; 5. Chronic renal failure requires hemodialysis or peritoneal dialysis; 6. Known or potential portal hypertension, chronic jaundice, chronic liver cirrhosis, ascites; 7. Severe liver failure (Child class C); 8. Volunteers who participated in other clinical trials within 30 days before the start of this trial; 9. Pregnant or lactating women; 10. Fungal sepsis; 11. The patient has a history of allergic reactions to biological products, hypersensitivity reactions or other serious reactions; 12. Long-term immunosuppressed patients; 13. Subjects deemed inappropriate by the investigator to participate in clinical research.

Design outcomes

Primary

MeasureTime frame
Serious adverse events;

Secondary

MeasureTime frame
Infection-related indicators;cytokine;cellular immunity;blood lactate;Blood biochemistry;Coagulation function;

Countries

China

Contacts

Public ContactTang Lunxian

Shanghai East Hospital (East Hospital Affiliated to Tongji University)

456tlx@163.com+86 18916290981

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026