MSCs for the Treatment of Burn Wounds

Study Overview
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Brief Summary
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The goal of this study is to evaluate the capacity of allogenic mesenchymal stromal cells form bone marrow (BM-MSC) or adipose tissue(Ad-MSC) to induce wound healing in patients with burn wounds.

Detailed Description
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Based on the paracrine and immunomodulatory effects of MSCs, they are considered promising cells for tissue engineering and skin regeneration in burn wounds. This protocol is designed to evaluate the efficacy of transplantation of allogenic BM-MSCs or Ad-MSCs, included in preclotted platelet-rich plasma (PRP), in patients with deep- or full-thickness burns (second- or third-degree / AB B or B degree). All patients will receive concomitant first-line treatments.

Official Title
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Allogenic Mesenchymal Stromal Cells for the Treatment of Burn Wounds.

Conditions
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Burn Wound, Second- or Third-degree Burn

Intervention / Treatment
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* Biological: Implantation of allogeneic MSCs on burn wounds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 2 weeks and 85 years old Patient with second- or third-degree burn (AB/B or B). Thermal burns Electrical burns Chemical burns Informed consent of the patient or caretaker Exclusion Criteria: First degree burn (A or AB) Evidence of active infection at the wound site Chronic malnutrition Systemic inflammatory response syndrome (SIRS) or sepsis Moderate or severe respiratory tract or lungs burn injuries Autoimmune disease (e.g. multiple sclerosis, lupus erythematosus) Severe pulmonary disease, hematologic disease, malignancy, or hypo-immunity. Diabetes Pregnancy

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogenic MSCs<br>All Patients will receive conservative treatment before transplantation of allogenic MSCs embedded in autologous platelet rich plasma clot. | Biological: Implantation of allogeneic MSCs on burn wounds<br>* Transplantation of allogeneic MSCs in patients with deep- or full-thickness burns. Allogeneic MSCs embedded in autologous platelet rich plasma clot (PRP) are implanted onto the burned areas. The treated areas will be covered with conventional dressings and burned roll. Dressings will be changed after 5 days and then weekly. The total number of MSCs used in each patient varied according to the burn injury. In patients with larger burned areas, its necessary to apply new treatments with MSCs in affected areas, at intervals of at least 1 month. Implantation will be performed in the operating room. Patients will receive first line treatments.<br>* Other names: Transplantation of MSCs on burn wounds;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-epithelialization areas | Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs | Up to 6 month | 
| Complete burn wound healing | Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs | Up to 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn wounds, skin regeneration, MSCs