MSCs for the Treatment of Burn Wounds

Allogenic Mesenchymal Stromal Cells for the Treatment of Burn Wounds.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Burn Wound; Second- or Third-degree Burn
• Intervention / Treatment: Biological: Implantation of allogeneic MSCs on 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Venezuela
  • Miranda
    • Caracas, Miranda, Venezuela, 1204
      • Instituto Venezolano de Investigaciones Cientificas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-epithelialization areas	Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs	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	Up to 12 month

Collaborators and Investigators

• Sponsor: Instituto Venezolano de Investigaciones Cientificas
• Collaborators: Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy; Unidad de Terapia Celular - IVIC; Hospital Pediátrico Niño Jesús, San Felipe, Yaracuy
• Investigators: Principal Investigator: Olga L Wittig, MSc, Instituto Venezolano de Investigaciones Cientificas

Publications and helpful links

General Publications

• Ramos-Gonzalez G, Salazar L, Wittig O, Diaz-Solano D, Cardier JE. The effects of mesenchymal stromal cells and platelet-rich plasma treatments on cutaneous wound healing. Arch Dermatol Res. 2023 May;315(4):815-823. doi: 10.1007/s00403-022-02451-y. Epub 2022 Nov 3.
• Wittig O, Diaz-Solano D, Chacin T, Rodriguez Y, Ramos G, Acurero G, Leal F, Cardier JE. Healing of deep dermal burns by allogeneic mesenchymal stromal cell transplantation. Int J Dermatol. 2020 Aug;59(8):941-950. doi: 10.1111/ijd.14949. Epub 2020 Jun 5.
• Pereira B, Duque K, Ramos-Gonzalez G, Diaz-Solano D, Wittig O, Zamora M, Gledhill T, Cardier JE. Wound healing by transplantation of mesenchymal stromal cells loaded on polyethylene terephthalate scaffold: Implications for skin injury treatment. Injury. 2023 Apr;54(4):1071-1081. doi: 10.1016/j.injury.2023.02.024. Epub 2023 Feb 13.
• Ramos-Gonzalez G, Wittig O, Diaz-Solano D, Salazar L, Ayala-Grosso C, Cardier JE. Evaluation of epithelial progenitor cells and growth factors in a preclinical model of wound healing induced by mesenchymal stromal cells. Biosci Rep. 2020 Jul 31;40(7):BSR20200461. doi: 10.1042/BSR20200461.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Burn wounds, skin regeneration, MSCs
• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: IVIC-UTC-MSC-Burn

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No