Clinical trial NCT03113747: Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds (ADSCs-BWs)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Second- or Third-degree Burns
Keywords: Allogeneic adipose-derived stem cells
burn wounds
wound healing
regeneration
repair
skin tissue engineering
Lead sponsor: A.A. Partners, LLC
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The degree of healing of skin flap; The degree of epithelialization of burn wounds in the perforations of a skin graft
timeFrame: up to 1 month
Secondary outcomes:
measure: The dynamics of healing of skin flap
timeFrame: up to 1 month
measure: Dynamics of the phagocytic activity of neutrophils in the area of burn wounds, according to NBT-test.
timeFrame: up to 1 month
measure: Duration of treatment (days) to complete epithelialization of burn wounds;
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: The Kyiv City Clinical Hospital №2
Study officials:
affiliation: The head doctor of The Kyiv City Clinical Hospital №2
name: Anatoliy V. Voronin
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of the department of combustiology and plastic surgery, Shupyk National Medical Academy of Postgraduate Education
name: Georgiy P. Kozynets, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexaki 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.