UnknownPhase 2

The Study of the Effectiveness of Tissue Equivalent on the Basis of Cultured Cells to Heal Skin Blemishes

Russia1 participantsStarted 2014-02

Plain-language summary

In Russia the treatment nonhealing skin defects often limited to surgical interventions, despite having developed modern methods of treatment of non-healing ulcers and other skin imperfections. During the many years of research we have developed a skin equivalent comprising living cells. During pilot trial showed that the skin equivalent provides healing skin defect within 1-4 weeks in 95% of patients.

Who can participate

Age range

18 Years – 70 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: * The presence of non-healing ulcer at least a month, an area of not less than 3 cm2 or smaller area of deep defects; * Availability of burns II or III level; * Epidermolysis bullosa; * Availability of post-burn scars * Defects in the skin after surgery Exclusion Criteria: * Acute and chronic diseases in the acute stage; * Autoimmune diseases of connective tissue (collagen); * Immunodeficiency states; * System of inflammatory diseases of the skin; * Conduct an aggressive corticosteroid therapy; * Acute coronary syndrome; * Acute disorders of cerebral circulation; * Availability of local inflammation in the acute stage; * Pregnancy; * Breast-feeding. * Positive results of the following tests: Anti-HIV-1 and -2, HIV-1Ag, anti-HTL VI and-II, anti-HbcorAg, HBs-Ag, anti-HCV, anti-CMV, anti-Toxoplasma gondii, RW, Neisseria gonorrheae, Chlamydia.

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

efficiency

Timeframe: six weeks

Trial details

NCT IDNCT01884831

SponsorUral State Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

Contact for this trial

Arteom V Korotkov

+73432421546 larim@mail.ru

View on ClinicalTrials.gov More Neurotrophic Ulcers trials