NCT01443689

Allogenic Stem Cell Therapy in Patients With Acute Burn

A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Acute Burn

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shenzhen Beike Bio-Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation will be evaluated in patients with acute burn.

Detailed description

To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Acute, Moderate-Severe, Full-thickness burn.

Conditions

• Burns

Interventions

Type	Name	Description
BIOLOGICAL	human umbilical cord mesenchymal stem cells	Participants will be given conventional therapy plus hUCMSCs transplantation.
BIOLOGICAL	human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells	Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.
DRUG	Conventional therapy	Participants will be given conventional therapy only.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-03-01
• Completion: 2013-07-01
• First posted: 2011-09-30
• Last updated: 2012-11-28

Locations

1 site across 1 country: China