Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485962
• Other study ID #: IBCE_Fibr(Burns)
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• skin burns of the 2nd degree

Exclusion Criteria:

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

• mental disorders

• pregnancy

Related Conditions & MeSH terms

• Burns

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Belarus	Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Belarusian Medical Academy of Post-Graduate Education

Country where clinical trial is conducted

Belarus, 

Outcome

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