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Efficacy and safety evaluation of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation in children with septic shock

Efficacy and safety evaluation of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation in children with septic shock

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017366
Enrollment
Unknown
Registered
2018-07-26
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-31

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

Conditions

children septic shock

Interventions

Phase I low dose group:Human umbilical cord derived mesenchymal stem cells (UC - MSCs)
Phase I moderate dose grou:Human umbilical cord derived mesenchymal stem cells (HU - MSCs)
Phase I high dose group:Human umbilical cord derived mesenchymal stem cells (HU - MSCs)
Phase II control group: Human umbilical cord derived mesenchymal stem cells (HU - MSCs)

Sponsors

Daping hospital, Army medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. TGood adherence to patients and their families with informed consents 2. PICU inpatients aged = 28d, 2 s, weak pulse, wet end of limbs; or capillary flash refilling, flood veins and pulse pressure widening; or urine volume 7 days

Exclusion criteria

Exclusion criteria: 1. Patients with the following diseases: bone marrow, lung, liver, kidney and other transplant history, genetic metabolic diseases; 2. The patient has a history of allergies to biological products, hypersensitivity reactions or other serious reactions; 3. The patient is in a predictable dying state; 4. Suffering from chromosomal abnormalities (such as 18-trisomy, 13-trisomy or 21-trisomy) or severe congenital malformations (such as hydrocephalus and brain swelling, tracheoesophageal fistula, abdominal wall defects and major renal abnormalities); 5. Surgery is expected within 72 hours before or after study drug administration; 6. History of malignant tumors in the past 5 years.

Design outcomes

Primary

MeasureTime frame
paediatric index of mortality, PIM;

Countries

China

Contacts

Public ContactXiang Xu

Research Institute of Surgery, Daping Hospital, Army Medical University

xiangxu@ymail.com+86 13637843870

Outcome results

None listed

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