Allogenic Stem Cell Therapy in Patients With Acute Burn

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burns

Intervention / Treatment
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* Biological: human umbilical cord mesenchymal stem cells
* Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
* Drug: Conventional therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group1 :Conventional plus hUCMSCs treatment<br>Participants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up. | Biological: human umbilical cord mesenchymal stem cells<br>* Participants will be given conventional therapy plus hUCMSCs transplantation.<br>|
| Experimental: Group 2: Conventional plus hCBMNCs and hUCMSCs therapy<br>Participants will be given conventional therapy plus combination of hCBMNCs together with hUCMSCs transplantation with a 6 months follow-up. | Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells<br>* Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.<br>|
| Active Comparator: Group 3:Conventional therapy<br>Participants will be given conventional therapy only with a 6 months follow-up. | Drug: Conventional therapy<br>* Participants will be given conventional therapy only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extensive Burn, Human Cord Blood Mononuclear Cells, Human Umbilical Cord Mesenchymal Stem Cells