Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds … (NCT03113747) | Clinical Trial Compass
UnknownPhase 1/2
Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds (ADSCs-BWs)
Ukraine20 participantsStarted 2015-03-25
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The degree of healing of skin flap; The degree of epithelialization of burn wounds in the perforations of a skin graft