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MSCs for the Treatment of Burn Wounds

Sponsor
Instituto Venezolano de Investigaciones Cientificas (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06103409
Collaborator
Unidad de Terapia Celular - IVIC (Other), Hospital Pediátrico Niño Jesús, San Felipe, Yaracuy (Other), Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy (Other)
50
Enrollment
1
Location
1
Arm
48
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Implantation of allogeneic MSCs on burn wounds
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Allogenic Mesenchymal Stromal Cells for the Treatment of Burn Wounds.
Actual Study Start Date :
Jun 30, 2021
Actual Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Allogenic MSCs

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.
Other Names:
  • Transplantation of MSCs on burn wounds

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Re-epithelialization areas [Up to 6 month]

      Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Weeks to 85 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Venezolano de Investigaciones Cientificas Caracas Miranda Venezuela 1204

    Sponsors and Collaborators

    • Instituto Venezolano de Investigaciones Cientificas
    • Unidad de Terapia Celular - IVIC
    • Hospital Pediátrico Niño Jesús, San Felipe, Yaracuy
    • Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy

    Investigators

    • Principal Investigator: Olga L Wittig, MSc, Instituto Venezolano de Investigaciones Cientificas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dylana Diaz Solano, Investigator, Instituto Venezolano de Investigaciones Cientificas
    ClinicalTrials.gov Identifier:
    NCT06103409
    Other Study ID Numbers:
    • IVIC-UTC-MSC-Burn
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 26, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dylana Diaz Solano, Investigator, Instituto Venezolano de Investigaciones Cientificas
    Burn wounds, skin regeneration, MSCs
    Additional relevant MeSH terms:
    Wounds and Injuries
    Burns

    Study Results

    No Results Posted as of Oct 26, 2023