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Completed

NCT Number: NCT04485962

Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts

Treatment of patients with burns of the skin of the 2nd degree using: autologous keratinocytes and skin fibroblasts mixed with collagen gel 7% (tissue equivalent of the skin)

Completed

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, 220072, Belarus

About this study

Treatment of patients with burns of the skin of the 2nd degree by applying a wound covering with layer-by-layer cultured autologous keratinocytes and fibroblasts in collagen gel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • skin burns of the 2nd degree

Exclusion criteria

  • acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
  • mental disorders
  • pregnancy

Treatment and study plan

Fibroblasts and keratinocytes

Biological

Autologous cultured fibroblasts and keratinocytes

For PR: The name " fibroblasts and keratinocytes" is exactly the name of the cell product registered by our ministry of health. There is no trade or international name.

Primary outcomes

  1. Number of cured patients

    Time frame: 1 month

    Number of patients cured

  2. Number of patients with treatment-related adverse events

    Time frame: 1 month

    Cell application related adverse events assessed by blood count, liver and function tests

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Other Gov

Collaborators

  • Belarusian Medical Academy of Post-Graduate Education

Registry information

Official study title

Treatment of Patients With Skin Burns Using Autologous Keratinocytes and Skin Fibroblasts

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2020
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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