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Burn WoundPhase 1/2NCT06103409

MSCs for the Treatment of Burn Wounds

A Phase 1/2 study testing Implantation of allogeneic MSCs on burn wounds in people with Burn Wound and Second- or Third-degree Burn, run by Instituto Venezolano de Investigaciones Cientificas at 1 site in Venezuela.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 weeks to 85 years
Conditions the study is for
Burn Wound, Second- or Third-degree Burn
What is being tested?
Implantation of allogeneic MSCs on burn wounds
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteVenezuela
Study dates
30 Jun 2021to 30 Jun 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 weeks to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • Severe pulmonary disease, hematologic disease, malignancy, or hypo-immunity.
  • Diabetes
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Venezuela1 site

  • Instituto Venezolano de Investigaciones Cientificas

    Caracas, Miranda, 1204

Other trials in Venezuela

About this study

Official title: Allogenic Mesenchymal Stromal Cells for the Treatment of Burn Wounds.

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.

Read the 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.

Being tested
Implantation of allogeneic MSCs on burn wounds
Keywords
Burn wounds, skin regeneration, MSCs
Medical subject headings
Burns, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantation of allogeneic MSCs on burn woundsBiological

    Also called Transplantation of 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.

Study groups in NCT06103409
Study groupRoleWhat they receive
Allogenic MSCsExperimentalAll Patients will receive conservative treatment before transplantation of allogenic MSCs embedded in autologous platelet rich plasma clot.
Receives: Biological: Implantation of allogeneic MSCs on burn wounds

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Re-epithelialization areas

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

    Measured: Up to 6 month

  2. Complete burn wound healing

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

    Measured: Up to 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2023
  2. Study start30 Jun 2021
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06103409
Sponsor's protocol ID
IVIC-UTC-MSC-Burn
Status last verified
Oct 2023
First submitted
23 Oct 2023
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32501530

  • 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.

    PubMed 36801131

  • 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.

    PubMed 36326886

  • 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.

    PubMed 32667622

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Implantation of allogeneic MSCs on burn wounds in people with Burn Wound and Second- or Third-degree Burn, run by Instituto Venezolano de Investigaciones Cientificas at 1 site in Venezuela.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Re-epithelialization areas (time frame: Up to 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06103409, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.

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