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

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

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 Overview

• Status: Unknown
• Conditions: Burns; Neurotrophic Ulcers
• Intervention / Treatment: Biological: study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Ekaterinburg, Russian Federation, 620028
    • Ural State Medical Academy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cell therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
efficiency	six weeks

Collaborators and Investigators

• Sponsor: Ural State Medical University
• Investigators: Study Chair: Oleg G Makeev, MD, Ural State Medical University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: damage to the skin, the skin equivalent, cell therapy
• Other Study ID Numbers: USMA01082012