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Effective and safety evaluation of human umbilical cord derived mesenchymal stem cells (HU - MSCs) in severe sepsis or septic shock

Effective and safety evaluation of human umbilical cord derived mesenchymal stem cells (HU - MSCs) in severe sepsis or septic shock

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005094
Enrollment
Unknown
Registered
2014-08-08
Start date
2014-10-01
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

severe sepsis or septic shock

Interventions

placebo group:normal saline with 1% human serum albumin

Sponsors

Cell Biotherapy Center, Daping Hospital, Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Good adherence to patients and their families with informed consents; 2. patients of ICU, aged from 16 to 65 years old; 3. Have a clear diagnosis of severe sepsis and septic shock; 4. Expected survival time longer than 28 days.

Exclusion criteria

Exclusion criteria: 1. Patients with uncorrected disease, such as advanced cancer or other terminal illness, the prospective survival period less than 28 days; 2. Patients in the foreseeable dying state; 3. HIV infected with CD4 less than 50/mm3; 4. Have the bone marrow, lungs, liver, pancreas, or history of small bowel transplantation; 5. Chronic renal failure need hemodialysis or peritoneal dialysis; 6. Known or potential of portal hypertension, chronic icteric, chronic liver cirrhosis and ascites; 7. Acute pancreatitis with no clear focal infection; 8. Patient participating or having participated in a clinical trial with another investigational drug Within 30 days before the start of this clinical trial; 9. Patient is pregnant or nursing; 10. Fungal sepsis; 11. History of patient is allergic to biological products, allergic reactions or other serious reaction.

Design outcomes

Primary

MeasureTime frame
28-Day All-Cause Mortality;

Countries

China

Contacts

Public ContactXiang Xu

Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing

xiangxu@ymail.com+86 13637843870

Outcome results

None listed

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