MSCs for the Treatment of Burn Wounds

Instituto Venezolano de Investigaciones Cientificas

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Second- or Third-degree Burn; Burn Wound

Treatments: Biological: Implantation of allogeneic MSCs on burn wounds

Study type: Interventional

Funder types: Other

Identifiers

NCT06103409

IVIC-UTC-MSC-Burn

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 weeks to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Allogenic MSCs

Experimental group

Description:

All Patients will receive conservative treatment before transplantation of allogenic MSCs embedded in autologous platelet rich plasma clot.

Treatment:

Biological: Implantation of allogeneic MSCs on burn wounds