Burn Wound, Second- or Third-degree Burn
Conditions
Keywords
Burn wounds, skin regeneration, MSCs
Brief summary
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
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.
Interventions
BIOLOGICALImplantation of allogeneic MSCs on burn wounds
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.
Sponsors
Unidad de Terapia Celular - IVIC
Hospital Pediátrico Niño Jesús, San Felipe, Yaracuy
Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy
Instituto Venezolano de Investigaciones Cientificas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-epithelialization areas | Up to 6 month | Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs |
| Complete burn wound healing | Up to 12 month | Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs |
Countries
Venezuela
Outcome results
None listed