BurnsPhase 1/2NCT04485962
Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts
A Phase 1/2 study testing Fibroblasts and keratinocytes in people with Burns, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Fibroblasts and keratinocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- skin burns of the 2nd degree
Who cannot join
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
- pregnancy
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
Official title: Treatment of Patients With Skin Burns Using Autologous Keratinocytes and Skin Fibroblasts
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)
Read the 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
- Conditions
- Burns
- Being tested
- Fibroblasts and keratinocytes
- Keywords
- burns, fibroblasts, keratinocytes
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Fibroblasts and keratinocytes treated patients | Experimental | Fibroblasts and keratinocytes treated patients Receives: Biological: Fibroblasts and keratinocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cured patients
Number of patients cured
Measured: 1 month
Number of patients with treatment-related adverse events
Cell application related adverse events assessed by blood count, liver and function tests
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education
- Responsible party
- Sponsor
- Investigators
- Igor Volotovski, Prof, Study director, Head of the Lab of Institute of Biophysics and Cell EngineeringVladimir Podgaiskiy, Prof, Study director, Head of the plastic surgery and combustiologyAlexey Chasnoit, Dr, Principal investigator, Dean of the plastic surgery and combustiologyZinaida Kvacheva, Dr, Principal investigator, Lead Researcher of Institute of Biophysics and Cell Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485962
- Sponsor's protocol ID
- IBCE_Fibr(Burns)
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Skin Burns Using Autologous Keratinocytes and Skin Fibroblasts
- ClinicalTrials.gov ID
- NCT04485962
- Acronym / sponsor ID
- IBCE_Fibr(Burns)
- Conditions
- Burns
- Keywords
- burns, fibroblasts, keratinocytes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibroblasts and keratinocytes treated patients | Experimental | Biological: Fibroblasts and keratinocytesFibroblasts and keratinocytes treated patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- skin burns of the 2nd degree
Key exclusion criteria (3 listed)
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibroblasts and keratinocytesAutologous 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. | Biological | Fibroblasts and keratinocytes treated patients |
Primary outcome
Number of cured patients
Time frame: 1 month
Number of patients cured
Number of patients with treatment-related adverse events
Time frame: 1 month
Cell application related adverse events assessed by blood count, liver and function tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Volotovski, Prof study director
Head of the Lab of Institute of Biophysics and Cell Engineering
Vladimir Podgaiskiy, Prof study director
Head of the plastic surgery and combustiology
Alexey Chasnoit, Dr principal investigator
Dean of the plastic surgery and combustiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fibroblasts and keratinocytes in people with Burns, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cured patients (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.