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

Phase 2 The Use of Tissue-equivalent Based on Cultured Cells for Healing Skin Blemishes

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01884831
Acronym
SETES
Enrollment
1
Registered
2013-06-24
Start date
2014-02-28
Completion date
2018-07-31
Last updated
2013-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Neurotrophic Ulcers

Keywords

damage to the skin, the skin equivalent, cell therapy

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.

Interventions

BIOLOGICALstudy of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions

Sponsors

Ural State Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frame
efficiencysix weeks

Countries

Russia

Contacts

Primary ContactArteom V Korotkov
larim@mail.ru+73432421546

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026