MSCs for the Treatment of Burn Wounds

NCT06103409 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-26

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06103409 on ClinicalTrials.gov