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Completed

NCT Number: NCT04483934

Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal Fibroblasts

Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy with local transplantation of autologous dermal fibroblasts

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Key information

Conditions

Trophic Ulcer Non-Healing Ulcer of Skin Non-healing Wound

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

During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous dermal fibroblasts in the wound.

The positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is due to the following:

  • the ability of fibroblasts to stimulate tissue regeneration
  • positive results of preclinical studies of the method of treatment of long-term non-healing wounds in animals (rats).

Twelve patients were included in the study. Dermal fibroblasts were isolated from the skin patients, cultured and then transplanted back to the wound.

The therapeutic dose of cells was 50k per cm2 of the wound area. Follow up patients monitoring was performed at 1, 2 and more months after injection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Trophic Ulcers
  • Chronic non-healing wounds

Exclusion criteria

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

Treatment and study plan

Dermal fibroblasts

Biological

Cultured autologous dermal fibroblasts.

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

LED Phototherapy

Device

LED phototherapy

Primary outcomes

  1. Number of patients with tropic ulcers cured

    Time frame: 1 month

    Number of patients cured

  2. Number of patients with treatment-related adverse events

    Time frame: 4 weeks

    Fibroblasts injection related adverse events assessed by blood count and function tests

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Registry information

Official study title

Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Local LED Phototherapy and Autologous Dermal Fibroblasts

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 23, 2020
Registry last updated
Jul 23, 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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