Burn WoundPhase 3keratinocyteNCT00978705
Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
A Phase 3 study testing Autologous cultured keratinocyte cell in people with Burn Wound, run by Biosolution Co., Ltd. at 1 site in South Korea.
Trial summary
The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Burn Wound
- What is being tested?
- Autologous cultured keratinocyte cell
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to Jan 2010
- Phase
- Phase 3
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age : 1~70 years
- More than 30% TBSA of second degree burn or more than 10% TBSA of third degree burn
- Must provide signed informed consent prior to participation in any study-related procedures
Who cannot join
- Have a pyogenic infection
- Part of the facial cosmetic surgery cost
- Hypersensitivity reactions in patients with bovine proteins
- Hypersensitivity reactions in patients with Gentamycin
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.
- Conditions
- Burn Wound
- Being tested
- Autologous cultured keratinocyte cell
- Keywords
- Keratinocyte Cell, severe burn wound
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous cultured keratinocyte cellDrug
Also called Keraheal
3x10^7 cell/ vial
What is being measured
The primary outcome is the main question the study is designed to answer.
engraftment assessment
Measured: 4week
Secondary outcomes (1)
the vancouver burn scar scale
Measured: 8, 12, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startNov 2007
- Primary completionMay 2008 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn WoundStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosolution Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wook Chun, MD, Principal investigator, Hangang Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978705
- Sponsor's protocol ID
- MCTT-KRH-06
- Acronym
- keratinocyte
- Status last verified
- Sep 2009
- First submitted
- 15 Apr 2009
- Last updated
- 17 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
- ClinicalTrials.gov ID
- NCT00978705
- Acronym / sponsor ID
- keratinocyte / MCTT-KRH-06
- Conditions
- Burn Wound
- Keywords
- Keratinocyte Cell, severe burn wound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Biosolution Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- May 2008 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 17 Sep 2009 (estimated)
- 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.
The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age : 1~70 years
- More than 30% TBSA of second degree burn or more than 10% TBSA of third degree burn
- Must provide signed informed consent prior to participation in any study-related procedures
Key exclusion criteria (5 listed)
- Have a pyogenic infection
- Part of the facial cosmetic surgery cost
- Hypersensitivity reactions in patients with bovine proteins
- Hypersensitivity reactions in patients with Gentamycin
- Pregnancy or lactation
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 |
|---|---|---|
| Autologous cultured keratinocyte cellAlso: Keraheal3x10^7 cell/ vial | Drug | – |
Primary outcome
engraftment assessment
Time frame: 4week
1 secondary outcome
the vancouver burn scar scale
Time frame: 8, 12, 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2009.
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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.
Wook Chun, MD principal investigator
Hangang Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous cultured keratinocyte cell in people with Burn Wound, run by Biosolution Co., Ltd. at 1 site in South Korea.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Sep 2009. 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 South Korea. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
engraftment assessment (time frame: 4week). 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 17 Sep 2009.