NCT01884831UnknownPhase 2
Phase 2 The Use of Tissue-equivalent Based on Cultured Cells for Healing Skin Blemishes
Ural State Medical University2 sites in 1 country1 target enrollmentStarted: February 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- efficiency
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
efficiency
Time Frame: six weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Korotkov Artem Vladimirovich
Senior Research Fellow
Ural State Medical University
Study Sites (2)
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