NCT03113747

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: A.A. Partners, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

For more than 20 years in clinical practice allogeneic transplantation of diploid fibroblasts (ADP) for burn wounds has been successfully used, it is used as an independent method, and a method of preparing wounds for autologous skin grafting \[1\]. The clinical efficacy of transplantation ADP, after the research done by E.V. Glushchenko; Rahayev AM \[2,3\] is not doubted. Several studies have shown the efficacy of stem cells in promoting faster and superior wound healing. Alexaki \[4\] successfully used adipose derived mesenchymal stem cells in wound healing in mice and compared their effect with dermal fibroblasts. The application of stem cells in wounds promoted more efficient reepithelialization by their proliferative effect on keratinocytes. In recent years, the world's leading burn centers attempted to restore the skin over large areas of burn wounds by epidermal layers transplantation of allogeneic cells cultured in culture medium. The information expected in the study will be based on the principles of evidence-based medicine and will have practical significance for the treatment of burn wounds. It is expected to show a positive effect of cultured multipotent mesenchymal stromal cells in the epithelization of burn wounds process as well as the extent and speed healing of skin flap during autologous skin grafting.

Conditions

• Second- or Third-degree Burns

Interventions

Type	Name	Description
BIOLOGICAL	ALLO-ASCs	1). Cryopreserved cell suspension of early passages of cultured allogeneic MSCs isolated from SVF obtained from lipoaspirate, a total of 10 mln. of cultured cells; 2).The TE-construct consisting of collagen- or fibrin-derived hydrogels and cells of early passages (up to P5) suspension of allogeneic cultured MSCs isolated from SVF obtained from lipoaspirate; 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.

Timeline

• Start date: 2015-03-25
• Primary completion: 2018-12-26
• Completion: 2018-12-26
• First posted: 2017-04-14
• Last updated: 2017-04-26

Locations

1 site across 1 country: Ukraine