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

U

Ural State Medical University

Status and phase

Unknown
Phase 2

Conditions

Burns
Neurotrophic Ulcers

Treatments

Biological: study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions

Study type

Interventional

Funder types

Other

Identifiers

NCT01884831
USMA01082012

Details and patient eligibility

About

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.

Enrollment

1 estimated patient

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Double Blind

1 participants in 1 patient group

cell therapy
Experimental group
Description:
study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions
Treatment:
Biological: study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions

Trial contacts and locations

1

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Central trial contact

Arteom V Korotkov

Data sourced from clinicaltrials.gov

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