Allogenic Stem Cell Therapy in Patients With Acute Burn

Phase 1

• Conditions: Burns
• Interventions: Biological: human umbilical cord mesenchymal stem cells; Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells; Drug: Conventional therapy

• Registration Number: NCT01443689
• Lead Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-26
• Last Update Posted: 2012-11-28
• Primary Completion: 2013-03
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Between age 18- 65 years, both gender.
• Diagnosed with Acute, Moderate-Severe, full-thickness burn:

Burn occurring within the 72 hours prior to administration. TBSA 20-55%, third degree wounds surface area < 19 % ;

• Willing to sign the Informed Consent Form.

Exclusion Criteria

• All other burns except thermal origin.
• Chronically malnourished, poor medical condition or shock
• Systemic inflammatory response syndrome (SIRS) or septicopyemia
• Moderate-severe inhalation injury airways to lung
• HIV+
• Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
• Severe pulmonary and hematological disease, malignancy or hypo-immunity.
• Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
• Pregnancy or lactation
• Enrollment in other trials in the last 3 months.
• Other criteria the investigator consider improper for inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1 :Conventional plus hUCMSCs treatment	human umbilical cord mesenchymal stem cells	Participants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up.
Group 2: Conventional plus hCBMNCs and hUCMSCs therapy	human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells	Participants will be given conventional therapy plus combination of hCBMNCs together with hUCMSCs transplantation with a 6 months follow-up.
Group 3:Conventional therapy	Conventional therapy	Participants will be given conventional therapy only with a 6 months follow-up.

Primary Outcome Measures

Name	Time	Method
The ratio of wound contraction and re-epithelialisation	6 months after treatment
Complete healing time for investigated burn area	6 months after treatment
Vancouver Scar Scale	6 months after treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of infections and bleedings in burn wounds	6 months after treatment]
Engraftment assessment: Vitality of the graft	6 months after treatment]
McGill pain Questionnaire	6 months after treatment
Incidence of Adverse Events and Serious Adverse Events	6 months after treatment

Trial Locations

Locations (1)

The Second Affiliated Hospital of Kunmming Medical College; 🇨🇳 Kunming, Yunnan, China