WoundsNCT01292122
Safety Study of VCT-01™ in Split-Thickness Skin Graft Donor Site Wounds
A study testing VCT-01 in people with Wounds, run by Organogenesis at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the safety of VCT-01 in split-thickness skin graft (STSG) donor site wounds and assess selected parameters of healing at the VCT-01-treated donor site. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Wounds
- What is being tested?
- VCT-01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Sep 2012
- Phase
- Interventional
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject is at least 18 years of age but no more than 55 years of age.
- Subject has a primary wound which requires treatment with a split-thickness skin graft; the graft cannot be harvested from a site from which a skin graft was previously obtained. If the primary wound is a result of a thermal or chemical burn, the total body surface area must be less than 15%.
- Females of childbearing potential must have a documented negative urine pregnancy test and must agree to use highly effective contraceptives for 6 months post-treatment.
- Subject has read, understood and signed a Health Research Ethics Board-approved Informed Consent Form.
- Subject is able and willing to comply with study procedures and instructions.
Who cannot join
- Female subjects who are pregnant or lactating.
- Clinically significant disease or condition that may compromise graft take and/or donor site healing (e.g. the presence of a bleeding disorder, capillary fragility, venous or arterial disorder directly affecting the donor site to be treated, known or suspected systemic malignancies, human immunodeficiency virus infection, renal or liver disease, uncontrolled diabetes mellitus, thrombocytopenia, vasculitis, poor nutritional status).
- Subjects who are currently receiving or have received within two months prior to treatment: systemic, inhaled or intranasal corticosteroids or immunosuppressant agents. Subjects receiving therapeutic doses of anticoagulants for pre-existing medical conditions (e.g. Plavix, Coumadin, Heparin, low molecular weight Heparin, non-steroidal anti-inflammatory drugs, herbal supplements), for whom a dose interruption from Screening through 2-Months post-treatment (pre-treatment / treatment / biopsy phase) is contraindicated, are excluded from the study.
- Any disorder (psychiatric, alcohol or substance abuse [within 12 months of treatment], physical disability) that might interfere with obtaining informed consent or the subject's ability to comply with study or protocol requirements, as determined by the Investigator.
- Subjects who have used any tobacco product within 3 months prior to treatment.
- Subjects previously treated with Apligraf®, Dermagraft or any other cell-based product, including autologous tissue at the treatment site.
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- Subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to treatment (medical or dental).
- Subjects, who in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
- Subjects, as determined by Screening immunology testing, that have specific antibodies to VCT-01 donor cell human leukocyte antigens.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Prospective, Randomized Study of VCT-01™ in Split-Thickness Skin Graft Donor Site Wounds
The purpose of this study is to evaluate the safety of VCT-01 in split-thickness skin graft (STSG) donor site wounds and assess selected parameters of healing at the VCT-01-treated donor site.
Read the detailed description
An initial cohort of 5 subjects will be allocated to Group A. When all subjects enrolled in Group A have completed 14 days of post-treatment follow-up, results of donor site evaluations, histological analyses and reported adverse events will be reviewed by the Investigator and study Sponsor. If the data is suggestive of clinical benefit following treatment and absent any serious and/or unexpected adverse events, which are, in the opinion of the investigator, related to the treatment, the remaining subjects will be enrolled and randomized to Groups B, C or D.
- Conditions
- Wounds
- Being tested
- VCT-01
- Keywords
- Wounds, Grafts, Wound Healing, Cell Therapy, Split-thickness skin graft donor site wound
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCT-01Device
Application of bi-layered living cell-based product (VCT-01) to STSG donor site wound at Day 0
| Study group | Role | What they receive |
|---|---|---|
| VCT-01-treated STSG donor site wound | Experimental | Application of VCT-01 to STSG donor site wound at Day 0 Receives: Device: VCT-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events and changes from Baseline Immunology at 1, 3, 6 and 12 Months
Frequency and severity of reported adverse events and changes in results of immunology testing at Months 1, 3, 6 and 12 post-treatment as compared to baseline testing
Measured: Up to 12 months post-treatment
Secondary outcomes (5)
Healing parameter
Percentage area of questionable viability
Measured: Day 4 post-treatment
Healing parameter
Percentage area of graft survival
Measured: Day 14 post-treatment
Healing parameter
Histological and immunohistochemical analyses to examine cellular composition and tissue architecture.
Measured: Up to 10 days post-treatment
Healing parameter
Microarray analysis to quantitatively measure molecular phenotypes expression.
Measured: Up to 10 days post-treatment
Healing parameter
Short tandem repeat analysis for persistence of VCT-01
Measured: Up to 12 Months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward E Tredget, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292122
- Sponsor's protocol ID
- 10-GDS-001-VCT
- Status last verified
- Dec 2012
- First submitted
- 28 Jan 2011
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Randomized Study of VCT-01™ in Split-Thickness Skin Graft Donor Site Wounds
- ClinicalTrials.gov ID
- NCT01292122
- Acronym / sponsor ID
- 10-GDS-001-VCT
- Conditions
- Wounds
- Keywords
- Wounds, Grafts, Wound Healing, Cell Therapy, Split-thickness skin graft donor site wound
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Feb 2011 (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 purpose of this study is to evaluate the safety of VCT-01 in split-thickness skin graft (STSG) donor site wounds and assess selected parameters of healing at the VCT-01-treated donor site.
Detailed description
An initial cohort of 5 subjects will be allocated to Group A. When all subjects enrolled in Group A have completed 14 days of post-treatment follow-up, results of donor site evaluations, histological analyses and reported adverse events will be reviewed by the Investigator and study Sponsor. If the data is suggestive of clinical benefit following treatment and absent any serious and/or unexpected adverse events, which are, in the opinion of the investigator, related to the treatment, the remaining subjects will be enrolled and randomized to Groups B, C or D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VCT-01-treated STSG donor site wound | Experimental | Device: VCT-01Application of VCT-01 to STSG donor site wound at Day 0 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is at least 18 years of age but no more than 55 years of age.
- Subject has a primary wound which requires treatment with a split-thickness skin graft; the graft cannot be harvested from a site from which a skin graft was previously obtained. If the primary wound is a result of a thermal or chemical burn, the total body surface area must be less than 15%.
- Females of childbearing potential must have a documented negative urine pregnancy test and must agree to use highly effective contraceptives for 6 months post-treatment.
- Subject has read, understood and signed a Health Research Ethics Board-approved Informed Consent Form.
- Subject is able and willing to comply with study procedures and instructions.
Key exclusion criteria (9 listed)
- Female subjects who are pregnant or lactating.
- Clinically significant disease or condition that may compromise graft take and/or donor site healing (e.g. the presence of a bleeding disorder, capillary fragility, venous or arterial disorder directly affecting the donor site to be treated, known or suspected systemic malignancies, human immunodeficiency virus infection, renal or liver disease, uncontrolled diabetes mellitus, thrombocytopenia, vasculitis, poor nutritional status).
- Subjects who are currently receiving or have received within two months prior to treatment: systemic, inhaled or intranasal corticosteroids or immunosuppressant agents. Subjects receiving therapeutic doses of anticoagulants for pre-existing medical conditions (e.g. Plavix, Coumadin, Heparin, low molecular weight Heparin, non-steroidal anti-inflammatory drugs, herbal supplements), for whom a dose interruption from Screening through 2-Months post-treatment (pre-treatment / treatment / biopsy phase) is contraindicated, are excluded from the study.
- Any disorder (psychiatric, alcohol or substance abuse [within 12 months of treatment], physical disability) that might interfere with obtaining informed consent or the subject's ability to comply with study or protocol requirements, as determined by the Investigator.
- Subjects who have used any tobacco product within 3 months prior to treatment.
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 |
|---|---|---|
| VCT-01Application of bi-layered living cell-based product (VCT-01) to STSG donor site wound at Day 0 | Device | VCT-01-treated STSG donor site wound |
Primary outcome
Number of participants with Adverse Events and changes from Baseline Immunology at 1, 3, 6 and 12 Months
Time frame: Up to 12 months post-treatment
Frequency and severity of reported adverse events and changes in results of immunology testing at Months 1, 3, 6 and 12 post-treatment as compared to baseline testing
5 secondary outcomes
Healing parameter
Time frame: Day 4 post-treatment
Healing parameter
Time frame: Day 14 post-treatment
Healing parameter
Time frame: Up to 10 days post-treatment
Healing parameter
Time frame: Up to 10 days post-treatment
Healing parameter
Time frame: Up to 12 Months post-treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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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.
Edward E Tredget, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VCT-01 in people with Wounds, run by Organogenesis at 1 site in Canada.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 Dec 2012. 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 Canada. 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.
Are results available for this study?
The study was stopped early. 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?
Number of participants with Adverse Events and changes from Baseline Immunology at 1, 3, 6 and 12 Months (time frame: Up to 12 months post-treatment). 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 20 Dec 2012.