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Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts

Primary Purpose

Burns

Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Fibroblasts and keratinocytes
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 Burns focused on measuring burns, fibroblasts, keratinocytes

Eligibility Criteria

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

Inclusion Criteria:

  • skin burns of the 2nd degree

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

Fibroblasts and keratinocytes treated patients

Arm Description

Fibroblasts and keratinocytes treated patients

Outcomes

Primary Outcome Measures

Number of cured patients
Number of patients cured
Number of patients with treatment-related adverse events
Cell application related adverse events assessed by blood count, liver 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
Belarusian Medical Academy of Post-Graduate Education
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1. Study Identification

Unique Protocol Identification Number
NCT04485962
Brief Title
Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts
Official Title
Treatment of Patients With Skin Burns Using Autologous Keratinocytes and Skin Fibroblasts
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (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
Belarusian Medical Academy of Post-Graduate Education

4. Oversight

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

5. Study Description

Brief Summary
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)
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
burns, fibroblasts, keratinocytes

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
Fibroblasts and keratinocytes treated patients
Arm Type
Experimental
Arm Description
Fibroblasts and keratinocytes treated patients
Intervention Type
Biological
Intervention Name(s)
Fibroblasts and keratinocytes
Intervention Description
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 Outcome Measure Information:
Title
Number of cured patients
Description
Number of patients cured
Time Frame
1 month
Title
Number of patients with treatment-related adverse events
Description
Cell application related adverse events assessed by blood count, liver and function tests
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: skin burns of the 2nd degree 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
Vladimir Podgaiskiy, Prof
Organizational Affiliation
Head of the plastic surgery and combustiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexey Chasnoit, Dr
Organizational Affiliation
Dean of the plastic surgery and combustiology
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 Skin Burns Using Keratinocytes and Skin Fibroblasts

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