Trials / Unknown
UnknownNCT06103409
MSCs for the Treatment of Burn Wounds
Allogenic Mesenchymal Stromal Cells for the Treatment of Burn Wounds.
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Instituto Venezolano de Investigaciones Cientificas · Academic / Other
- Sex
- All
- Age
- 2 Weeks – 85 Years
- Healthy volunteers
- Not accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 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. |
Timeline
- Start date
- 2021-06-30
- Primary completion
- 2023-06-30
- Completion
- 2025-06-30
- First posted
- 2023-10-26
- Last updated
- 2023-10-26
Locations
1 site across 1 country: Venezuela
Source: ClinicalTrials.gov record NCT06103409. Inclusion in this directory is not an endorsement.