Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds (ADSCs-BWs) (ADSCs-BWs)
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|ClinicalTrials.gov Identifier: NCT03113747|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : April 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Second- or Third-degree Burns||Biological: ALLO-ASCs||Phase 1 Phase 2|
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 .
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  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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 25, 2015|
|Estimated Primary Completion Date :||December 26, 2018|
|Estimated Study Completion Date :||December 26, 2018|
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
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.
Other Name: Allogeneic adipose-derived stem cells
No Intervention: The standard treatment
All patients will be subjected to standard stepped treatment of burn wounds:
- The degree of healing of skin flap; The degree of epithelialization of burn wounds in the perforations of a skin graft [ Time Frame: up to 1 month ]The degree of healing of skin flap after autologous skin grafting;
- The dynamics of healing of skin flap [ Time Frame: up to 1 month ]Complete epithelization or epithelization more than 50% of the cells in the skin graft on the 10th day after autologous skin grafting are effective. The epithelialization less than 50% is not effective.
- Dynamics of the phagocytic activity of neutrophils in the area of burn wounds, according to NBT-test. [ Time Frame: up to 1 month ]Dynamics of the phagocytic activity of neutrophils in the area of burn wounds, according to NBT-test.
- Duration of treatment (days) to complete epithelialization of burn wounds; [ Time Frame: up to 1 month ]Duration of treatment (days) to complete epithelialization of burn wounds;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113747
|Contact: Volodymyr S. Melnyk, MD, DSc||+380679337461||V.Melnyk@ilaya.ua|
|Contact: Nataliia M. Olijnyk, PhD||+380934040116||N.Olijnyk@ilaya.ua|
|The Kyiv City Clinical Hospital №2||Recruiting|
|Kyiv, Ukraine, 02094,13, Krakivska, str.,|
|Contact: Georgiy P. Kozynets, MD, PhD, DSc +380973917611 email@example.com|
|Contact: Nataliia M. Olijnyk, PhD +380904040116 N.Olijnyk@ilaya.ua|
|Sub-Investigator: Dmytro O. Zubov, PhD|
|Sub-Investigator: Roman G. Vasyliev|
|Principal Investigator:||Anatoliy V. Voronin||The head doctor of The Kyiv City Clinical Hospital №2|
|Principal Investigator:||Georgiy P. Kozynets, MD, PhD, DSc||Head of the department of combustiology and plastic surgery, Shupyk National Medical Academy of Postgraduate Education|