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Completed

NCT Number: NCT04457037

Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells

Treatment of patients with trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound

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Key information

Conditions

Trophic Ulcer

Age range

18 year–80 year

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 adipose-derived mesenchymal stem cells in the wound. The positive outlook for the effectiveness of MSCs is due to the following:

  • the ability of MSCs to stimulate tissue regeneration
  • positive results of preclinical studies of the method of treatment of trophic ulcers in animals (rats).

In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will occur at 1，2 and 3, 6, 12, 22 months after injection.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Trophic Ulcers

Exclusion criteria

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

Treatment and study plan

Autologous adipose-derived mesenchymal stem cells

Biological

Autologous adipose-derived mesenchymal stem cells

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

    MSC 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

  • Belarusian State Medical University

Registry information

Official study title

Treatment of Patients With Trophic Ulcers Using Autologous Adipose-derived Mesenchymal Stem Cells

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 7, 2020
Registry last updated
Jul 7, 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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