NCT04485962

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

July 17, 2020

Last Update Submit

July 21, 2020

Conditions

Burns

Keywords

burnsfibroblastskeratinocytes

Outcome Measures

Primary Outcomes (2)

  • Number of cured patients

    Number of patients cured

    1 month

  • Number of patients with treatment-related adverse events

    Cell application related adverse events assessed by blood count, liver and function tests

    1 month

Study Arms (1)

Fibroblasts and keratinocytes treated patients

EXPERIMENTAL

Fibroblasts and keratinocytes treated patients

Biological: Fibroblasts and keratinocytes

Interventions

Fibroblasts and keratinocytesBIOLOGICAL

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.

Fibroblasts and keratinocytes treated patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • skin burns of the 2nd degree

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Igor Volotovski, Prof

    Head of the Lab of Institute of Biophysics and Cell Engineering

    STUDY DIRECTOR

  • Vladimir Podgaiskiy, Prof

    Head of the plastic surgery and combustiology

    STUDY DIRECTOR

  • Alexey Chasnoit, Dr

    Dean of the plastic surgery and combustiology

    PRINCIPAL INVESTIGATOR

  • Zinaida Kvacheva, Dr

    Lead Researcher of Institute of Biophysics and Cell Engineering

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 24, 2020

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)