A Phase 1/2 interventional study of Implantation of allogeneic MSCs on burn wounds in Burn Wound and Second- or Third-degree Burn, sponsored by Instituto Venezolano de Investigaciones Cientificas. Enrolling by invitation at 1 site in Venezuela. Open to participants aged 2 Weeks to 85 Years. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Instituto Venezolano de Investigaciones Cientificas · Phase 1/2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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.
Also known as: Transplantation of MSCs on burn wounds
Re-epithelialization areas
Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
Time frame: 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
Time frame: Up to 12 month
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Instituto Venezolano de Investigaciones Cientificas