MSCs for the Treatment of Burn Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Burn Wound Second- or Third-degree Burn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Allogenic MSCs

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

Group Type EXPERIMENTAL

Implantation of allogeneic MSCs on burn wounds

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Transplantation of MSCs on burn wounds

Eligibility Criteria

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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

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No