MSCs for the Treatment of Burn Wounds
NCT06103409 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-10-26
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.
Conditions
- Burn Wound
- Second- or Third-degree Burn
Interventions
- 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.
Sponsors & Collaborators
-
Unidad de Terapia Celular - IVIC
collaborator UNKNOWN -
Hospital Pediátrico Niño Jesús, San Felipe, Yaracuy
collaborator UNKNOWN -
Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy
collaborator UNKNOWN -
Instituto Venezolano de Investigaciones Cientificas
lead OTHER
Principal Investigators
-
Olga L Wittig, MSc · Instituto Venezolano de Investigaciones Cientificas
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Weeks
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-30
- Primary Completion
- 2023-06-30
- Completion
- 2025-06-30
Countries
- Venezuela
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