Clinical trial · Interventional
Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds (ADSCs-BWs)
Safety and Efficacy Evaluation of Tissue Engineered Construct Based on Allogeneic Adipose-derived Multipotent Mesenchymal Stromal Cells and Platelet-poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds
NCT03113747CI-TRIAL-00027208ADSCs-BWsunknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate safety and efficacy of tissue engineered construct based on allogeneic cultured adipose-derived multipotent mesenchymal stromal cells (ALLO-ADSCs) and platelet-poor plasma fibrin hydrogel to treat patients with 2-B and 3- degree burn wounds
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Second- or Third-degree Burns | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALLO-ASCs | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ALLO-ASCs
- description
- The patients receive ALLO-ADSCs. Biological is applied by surface application over perforated (1:3) autologous skin graft following the covering with hypoadhesive bandage. This procedure is carried out twice - once simultaneously with a skin grafting procedure and 2-3 days following autodermoplasty, while bandaging
- interventionNames
- Biological: ALLO-ASCs
- type
- NO_INTERVENTION
- label
- The standard treatment
- description
- All patients will be subjected to standard stepped treatment of burn wounds: * Infusion therapy aimed to eliminate disorders of homeostasis during burn shock and burn toxemia; * Systemic antibiotic therapy for preventing infectious complications; * Adequate analgesia and sedation; * Decompression necrotomy in the first 24 hours following the burn trauma; * Necrectomy simultaneously with imposition of lyophilized xenografts performed in the first 1-5 days after applying burn; * Autologous skin grafting 3-5 days after performed xenografts with the perforation coefficient 1:3
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female aged 18-65 years; * Patients with 2-nd B and 3-d degree burn wound; * Body surface area involved in burns - from 10 to 50%; * The area of skin grafting - less than 6% of the skin surface; * Burn occurring within the 24 hours prior to the hospitalization; * Adequate antishock therapy in the prehospital phase; * Women of childbearing age to provide proof of a current, valid negative pregnancy test; * Confirmation of participation in the study by signing the Instrument of Consent, personally or through a responsible caretaker. Exclusion Criteria: * Prognostically favorable or unfavorable outcome of the disease * (Lesion Severity Index, less than 30 or more, than 120 score); * Combined trauma; * Severe respiratory tract burn injuries; * Ischemic disease of the lower extremities; * The presence of cardiovascular disease (CVD): symptoms of unstable angina, myocarditis, heart disease, heart failure; * History of prior cancer; * Healing of duodenal or gastric ulcers in history; * Diabetes * Severe chronic liver diseases or kidney disease in history; * History of alcohol or other drug abuse; * Pregnanсy; * Any other physical diseases in decompensation or subcompensation, * or those that are rated as severe or moderate; * Therapeutic issues or psychiatric disorders of a patient which would * make the subject unsuitable to participate in this study or to complete it; * Participation in another clinical trial
References
Publications (1)
- BACKGROUNDAlexaki VI, Simantiraki D, Panayiotopoulou M, Rasouli O, Venihaki M, Castana O, Alexakis D, Kampa M, Stathopoulos EN, Castanas E. Adipose tissue-derived mesenchymal cells support skin reepithelialization through secretion of KGF-1 and PDGF-BB: comparison with dermal fibroblasts. Cell Transplant. 2012;21(11):2441-54. doi: 10.3727/096368912X637064. Epub 2012 Apr 10. PMID 22507764