Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts

Phase 1

Completed

• Conditions: Burns
• Interventions: Biological: Fibroblasts and keratinocytes

• Registration Number: NCT04485962
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• skin burns of the 2nd degree

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fibroblasts and keratinocytes treated patients	Fibroblasts and keratinocytes	Fibroblasts and keratinocytes treated patients

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment-related adverse events	1 month	Cell application related adverse events assessed by blood count, liver and function tests
Number of cured patients	1 month	Number of patients cured

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus