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Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts

NCT ID: NCT04485962

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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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)

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Detailed Description

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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

Conditions

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Burns

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fibroblasts and keratinocytes treated patients

Fibroblasts and keratinocytes treated patients

Group Type EXPERIMENTAL

Fibroblasts and keratinocytes

Intervention Type BIOLOGICAL

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.

Interventions

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Fibroblasts and keratinocytes

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* skin burns of the 2nd degree

Exclusion Criteria

* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian Medical Academy of Post-Graduate Education

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Igor Volotovski, Prof

Role: STUDY_DIRECTOR

Head of the Lab of Institute of Biophysics and Cell Engineering

Vladimir Podgaiskiy, Prof

Role: STUDY_DIRECTOR

Head of the plastic surgery and combustiology

Alexey Chasnoit, Dr

Role: PRINCIPAL_INVESTIGATOR

Dean of the plastic surgery and combustiology

Zinaida Kvacheva, Dr

Role: PRINCIPAL_INVESTIGATOR

Lead Researcher of Institute of Biophysics and Cell Engineering

Locations

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

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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IBCE_Fibr(Burns)

Identifier Type: -

Identifier Source: org_study_id

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