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 range
18 Years – 65 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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