NCT06103409

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

October 23, 2023

Last Update Submit

October 23, 2023

Conditions

Burn WoundSecond- or Third-degree Burn

Keywords

Burn wounds, skin regeneration, MSCs

Outcome Measures

Primary Outcomes (2)

  • Re-epithelialization areas

    Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs

    Up to 6 month

  • Complete burn wound healing

    Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs

    Up to 12 month

Study Arms (1)

Allogenic MSCs

EXPERIMENTAL

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

Biological: Implantation of allogeneic MSCs on burn wounds

Interventions

Implantation of allogeneic MSCs on burn woundsBIOLOGICAL

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.

Also known as: Transplantation of MSCs on burn wounds
Allogenic MSCs

Eligibility Criteria

Age2 Weeks - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Venezolano de Investigaciones Cientificas

Caracas, Miranda, 1204, Venezuela

Location

Related Publications (4)

  • Wittig O, Diaz-Solano D, Chacin T, Rodriguez Y, Ramos G, Acurero G, Leal F, Cardier JE. Healing of deep dermal burns by allogeneic mesenchymal stromal cell transplantation. Int J Dermatol. 2020 Aug;59(8):941-950. doi: 10.1111/ijd.14949. Epub 2020 Jun 5.

    PMID: 32501530BACKGROUND

  • Pereira B, Duque K, Ramos-Gonzalez G, Diaz-Solano D, Wittig O, Zamora M, Gledhill T, Cardier JE. Wound healing by transplantation of mesenchymal stromal cells loaded on polyethylene terephthalate scaffold: Implications for skin injury treatment. Injury. 2023 Apr;54(4):1071-1081. doi: 10.1016/j.injury.2023.02.024. Epub 2023 Feb 13.

    PMID: 36801131BACKGROUND

  • Ramos-Gonzalez G, Salazar L, Wittig O, Diaz-Solano D, Cardier JE. The effects of mesenchymal stromal cells and platelet-rich plasma treatments on cutaneous wound healing. Arch Dermatol Res. 2023 May;315(4):815-823. doi: 10.1007/s00403-022-02451-y. Epub 2022 Nov 3.

    PMID: 36326886BACKGROUND

  • Ramos-Gonzalez G, Wittig O, Diaz-Solano D, Salazar L, Ayala-Grosso C, Cardier JE. Evaluation of epithelial progenitor cells and growth factors in a preclinical model of wound healing induced by mesenchymal stromal cells. Biosci Rep. 2020 Jul 31;40(7):BSR20200461. doi: 10.1042/BSR20200461.

    PMID: 32667622BACKGROUND

MeSH Terms

Conditions

BurnsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olga L Wittig, MSc

    Instituto Venezolano de Investigaciones Cientificas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 26, 2023

Study Start

June 30, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2025

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations

VE(1)