Clinical trial

Allogenic Mesenchymal Stromal Cells for the Treatment of Burn Wounds.

Name

IVIC-UTC-MSC-Burn

Description

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.

Trial arms

Trial start

2021-06-30

Estimated PCD

2023-06-30

Trial end

2025-06-30

Phase

Early phase I

Treatment

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.

Arms:

Allogenic MSCs

Other names:

Transplantation of MSCs on burn wounds

Size

Primary endpoint

Re-epithelialization areas

Up to 6 month

Complete burn wound healing

Up to 12 month

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-10-26

1 organization

1 product

2 indications

Organization

Instituto Venezolano de Investigaciones Cientificas

Product

Allogeneic MSCs

Indication

Burn Wound

Indication

Burn