Clinical trial NCT06103409: MSCs for the Treatment of Burn Wounds
Official title: Allogenic Mesenchymal Stromal Cells for the Treatment of Burn Wounds.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Burn Wound
Second- or Third-degree Burn
Keywords: Burn wounds, skin regeneration, MSCs
Lead sponsor: Instituto Venezolano de Investigaciones Cientificas
Sponsor class: OTHER
Collaborators: name: Unidad de Terapia Celular - IVIC
name: Hospital Pediátrico Niño Jesús, San Felipe, Yaracuy
name: Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy
First posted: 2023-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Re-epithelialization areas
timeFrame: Up to 6 month
measure: Complete burn wound healing
timeFrame: Up to 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Instituto Venezolano de Investigaciones Cientificas
state: Miranda
Study officials:
affiliation: Instituto Venezolano de Investigaciones Cientificas
name: Olga L Wittig, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.