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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Dermal fibroblasts
LED phototherapy
Sponsored by
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trophic Ulcer focused on measuring Trophic Ulcer, Non-healing Wound, Dermal fibroblasts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Trophic Ulcers
  • Chronic non-healing wounds

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients treated with dermal fibroblasts

Arm Description

Cultured dermal fibroblasts and LED phototherepy

Outcomes

Primary Outcome Measures

Number of patients with tropic ulcers cured
Number of patients cured
Number of patients with treatment-related adverse events
Fibroblasts injection related adverse events assessed by blood count and function tests

Secondary Outcome Measures

Full Information

First Posted
July 17, 2020
Last Updated
July 21, 2020
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
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1. Study Identification

Unique Protocol Identification Number
NCT04483934
Brief Title
Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal Fibroblasts
Official Title
Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Local LED Phototherapy and Autologous Dermal Fibroblasts
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 28, 2014 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trophic Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin
Keywords
Trophic Ulcer, Non-healing Wound, Dermal fibroblasts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients treated with dermal fibroblasts
Arm Type
Experimental
Arm Description
Cultured dermal fibroblasts and LED phototherepy
Intervention Type
Biological
Intervention Name(s)
Dermal fibroblasts
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
LED phototherapy
Intervention Description
LED phototherapy
Primary Outcome Measure Information:
Title
Number of patients with tropic ulcers cured
Description
Number of patients cured
Time Frame
1 month
Title
Number of patients with treatment-related adverse events
Description
Fibroblasts injection related adverse events assessed by blood count and function tests
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Trophic Ulcers Chronic non-healing wounds Exclusion Criteria: acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis mental disorders pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Volotovski, Prof
Organizational Affiliation
Head of the Lab of Institute of Biophysics and Cell Engineering
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stanislav Tretyak, Prof
Organizational Affiliation
Head of 2nd Department of Surgical Diseases of BSMU
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Evgeny Baranov, Dr
Organizational Affiliation
Ass prof of 2nd Department of Surgical Diseases of BSMU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zinaida Kvacheva, Dr
Organizational Affiliation
Lead Researcher of Institute of Biophysics and Cell Engineering
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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