Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts

Treatment of Patients With Skin Burns Using Autologous Keratinocytes and Skin Fibroblasts

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04485962

Enrollment

Registered

2020-07-24

Start date

2017-01-01

Completion date

2019-12-31

Last updated

2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

burns, fibroblasts, keratinocytes

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

Interventions

BIOLOGICALFibroblasts 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* skin burns of the 2nd degree

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026