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| Name | Class |
|---|---|
| The Second Affiliated Hospital of Kunming Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 :Conventional plus hUCMSCs treatment | Experimental | Participants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up. |
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| Group 2: Conventional plus hCBMNCs and hUCMSCs therapy | Experimental | Participants will be given conventional therapy plus combination of hCBMNCs together with hUCMSCs transplantation with a 6 months follow-up. |
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| Group 3:Conventional therapy | Active Comparator | Participants will be given conventional therapy only with a 6 months follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human umbilical cord mesenchymal stem cells | Biological | Participants will be given conventional therapy plus hUCMSCs transplantation. |
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| 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 |
| 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 |
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Inclusion Criteria:
Burn occurring within the 72 hours prior to administration. TBSA 20-55%, third degree wounds surface area < 19 % ;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinfeng Fu | Contact | 86-871-5351281 | ynfjf@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Kunmming Medical College | Recruiting | Kunming | Yunnan | 650033 | China |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells | Biological | Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation. |
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| Conventional therapy | Drug | Participants will be given conventional therapy only. |
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| 6 months after treatment |
| Incidence of Adverse Events and Serious Adverse Events | 6 months after treatment |