Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds (ADSCs-BWs)

A.A. Partners

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Second- or Third-degree Burns

Treatments: Biological: ALLO-ASCs

Study type: Interventional

Funder types: Other

Identifiers

NCT03113747

MSC-P1

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

ALLO-ASCs

Experimental group

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

Treatment:

Biological: ALLO-ASCs

The standard treatment

No Intervention group

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