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

NCT ID: NCT01884831

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neurotrophic Ulcers Burns

Keywords

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damage to the skin, the skin equivalent, cell therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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cell therapy

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

Interventions

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ural State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Korotkov Artem Vladimirovich

Senior Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oleg G Makeev, MD

Role: STUDY_CHAIR

Ural State Medical University

Locations

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Ural State Medical Academy

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Central Contacts

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Arteom V Korotkov

Role: CONTACT

Phone: +73432421546

Email: [email protected]

Other Identifiers

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USMA01082012

Identifier Type: -

Identifier Source: org_study_id