Status:
UNKNOWN
MSCs for the Treatment of Burn Wounds
Lead Sponsor:
Instituto Venezolano de Investigaciones Cientificas
Collaborating Sponsors:
Unidad de Terapia Celular - IVIC
Hospital Pediátrico Niño Jesús, San Felipe, Yaracuy
Conditions:
Burn Wound
Second- or Third-degree Burn
Eligibility:
All Genders
2-85 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06103409
Start Date
June 30 2021
End Date
June 30 2025
Last Update
October 26 2023
Active Locations (1)
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1
Instituto Venezolano de Investigaciones Cientificas
Caracas, Miranda, Venezuela, 1204