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

July 21, 2020 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220072
        • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Trophic Ulcers
  • Chronic non-healing wounds

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients treated with dermal fibroblasts
Cultured dermal fibroblasts and LED phototherepy
Biological: Dermal fibroblasts

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.

Device: LED phototherapy
LED phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with tropic ulcers cured
Time Frame: 1 month
Number of patients cured
1 month
Number of patients with treatment-related adverse events
Time Frame: 4 weeks
Fibroblasts injection related adverse events assessed by blood count and function tests
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Investigators

  • Study Director: Stanislav Tretyak, Prof, Head of 2nd Department of Surgical Diseases of BSMU
  • Principal Investigator: Evgeny Baranov, Dr, Ass prof of 2nd Department of Surgical Diseases of BSMU
  • Principal Investigator: Zinaida Kvacheva, Dr, Lead Researcher of Institute of Biophysics and Cell Engineering

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2014

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCE_Fibr(TrophicUlcer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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