MSCs for the Treatment of Burn Wounds

Phase 1

• Conditions: Burn Wound; Second- or Third-degree Burn
• Interventions: Biological: Implantation of allogeneic MSCs on burn wounds

• Registration Number: NCT06103409
• Lead Sponsor: Instituto Venezolano de Investigaciones Cientificas

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.

Study Timeline

• Study Start: 2021-06-30
• Primary Completion: 2023-06-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allogenic MSCs	Implantation of allogeneic MSCs on burn wounds	All Patients will receive conservative treatment before transplantation of allogenic MSCs embedded in autologous platelet rich plasma clot.

Primary Outcome Measures

Name	Time	Method
Re-epithelialization areas	Up to 6 month	Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
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

Trial Locations

Locations (1)

Instituto Venezolano de Investigaciones Cientificas; 🇻🇪 Caracas, Miranda, Venezuela