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

NCT01884831 | Unknown Phase 2 DMC

• 1 other identifier: USMA01082012
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurotrophic Ulcers; Burns

Keywords

damage to the skin, the skin equivalent, cell therapy

Outcome Measures

Primary Outcomes (1)

• efficiency

  six weeks

Study Arms (1)

cell therapy

EXPERIMENTAL

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

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

Interventions

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

cell therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ural State Medical University: lead

Study Sites (1)

Ural State Medical Academy

Yekaterinburg, 620028, Russia

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Oleg G Makeev, MD

  Ural State Medical University

  STUDY CHAIR

Central Study Contacts

Arteom V Korotkov

CONTACT

+73432421546; larim@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 24, 2013
• Study Start: February 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

RU (1)