MSCs for the Treatment of Burn Wounds

Burn Wound Clinical Trial

Official title:

Allogenic Mesenchymal Stromal Cells for the Treatment of Burn Wounds.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06103409
• Other study ID #: IVIC-UTC-MSC-Burn
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: June 30, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: Instituto Venezolano de Investigaciones Cientificas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Weeks to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Wound
• Burns
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Venezuela	Instituto Venezolano de Investigaciones Cientificas	Caracas	Miranda

Sponsors (4)

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

Country where clinical trial is conducted

Venezuela, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-epithelialization areas	Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs	Up to 6 month
Primary	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