EPIDERMOLYSIS BULLOSAPhase 2TCEBNCT00987142
Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa
A Phase 2 study testing CX501 and Occlusive non adherent dressing in people with EPIDERMOLYSIS BULLOSA, run by Tigenix S.A.U. at 2 sites in Spain.
Trial summary
A phase II, comparative, open label, prospective, multicentre clinical trial where each patient will undergo two procedures; implant of a patch of cultured chimeric skin (experimental therapy) in a half of the skin lesion and an occlusive non-adherent dressing (control) in the other half for 12 months of follow-up in… Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- EPIDERMOLYSIS BULLOSA
- What is being tested?
- CX501 and Occlusive non adherent dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSpain
- Study dates
- Dec 2006to May 2010
- Phase
- Phase 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 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of both sexes over 28 days of age.
- Patients with recessive dystrophic epidermolysis bullosa diagnosed by clinical and historical criteria with severe skin syndactyly in whom reconstructive surgery is indicated.
- Patients whose legal guardians have given written informed consent for participation in the study before any study procedure is performed.
- Patients aged ≥ 12 years who have given written informed consent for participation in the study before any study procedure is performed.
Who cannot join
- Women of childbearing age not using effective contraceptive methods (oral contraception)
- Pregnant or nursing women
- Documented or suspected hypersensitivity to any of the therapeutic agents included in the study, including anaesthetic drugs.
- Patients with a history of malignant tumor in the past 5 years
- Patients with a diagnosis of active tuberculosis at the time of recruitment
- Patients with prior positive markers for any of the following pathogens: hepatitis b and c, hiv-1 and hiv-2
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- Patients with a history of clinically relevant hepatic, gastrointestinal, haematological, pulmonary, or neurological disease no directly related to epidermolysis bullosa.
- Any other medical condition which, in the investigator´s judgment, might interfere with optimal participation in the study or involve a significant risk for the patient.
- Alcoholism, drug addiction, psychiatric disorders, or other factors present in legal guardians which,in the investigator´s judgment may complicate patient participation in the study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Comparative Open-Label Multicentre Clinical Trial To Assess The Efficacy And Safety Of A New Therapy With Cultured Chimeric Skin For The Treatment Of Skin Lesions In Patients With Epidermolysis Bullosa
A phase II, comparative, open label, prospective, multicentre clinical trial where each patient will undergo two procedures; implant of a patch of cultured chimeric skin (experimental therapy) in a half of the skin lesion and an occlusive non-adherent dressing (control) in the other half for 12 months of follow-up in two Spanish centres.
Read the detailed description
Reconstruction of interdigital commisures in patients with severe skin syndactyly using laminar grafts that will be uniformly and systematically taken with an electrical or compressed air dermatome on an aseptic area and with the same extent and depth in microns in all patients.
Immediately after the surgical procedure, a patch of cultured chimeric skin (experimental therapy) will be implanted in a half of the skin defect of the patient, and an occlusive non - adherent dressing (control) will be implanted in the other half.
Patients will initially be followed up every two days until epithelisation occurs (approximately 21 days after surgery) and at 3,8,and 12 months of follow-up.
- Conditions
- EPIDERMOLYSIS BULLOSA
- Being tested
- CX501, Occlusive non adherent dressing
- Medical subject headings
- Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX501Drug
Cultured chimeric skin
Occlusive non adherent dressingDevice
Application of an occlusive non adherent dressing in the skin donor site
| Study group | Role | What they receive |
|---|---|---|
| CX501 | Experimental | Cultured chimeric skin Receives: Drug: CX501 |
| Non adherent dressing | Active comparator | Occlusive non adherent dressing Receives: Device: Occlusive non adherent dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to epithelization
Measured: 21 days
Secondary outcomes (2)
Fibroblast persistence
Measured: 3, 8 and 12 months
Incidence of Adverse Events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startDec 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EPIDERMOLYSIS BULLOSAStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tigenix S.A.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Carlos López, MD, Principal investigator, Hospital La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987142
- Sponsor's protocol ID
- CX501/TCEB
- Acronym
- TCEB
- Status last verified
- Jul 2019
- First submitted
- 29 Sep 2009
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Open-Label Multicentre Clinical Trial To Assess The Efficacy And Safety Of A New Therapy With Cultured Chimeric Skin For The Treatment Of Skin Lesions In Patients With Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT00987142
- Acronym / sponsor ID
- TCEB / CX501/TCEB
- Conditions
- EPIDERMOLYSIS BULLOSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tigenix S.A.U.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 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.
A phase II, comparative, open label, prospective, multicentre clinical trial where each patient will undergo two procedures; implant of a patch of cultured chimeric skin (experimental therapy) in a half of the skin lesion and an occlusive non-adherent dressing (control) in the other half for 12 months of follow-up in two Spanish centres.
Detailed description
Reconstruction of interdigital commisures in patients with severe skin syndactyly using laminar grafts that will be uniformly and systematically taken with an electrical or compressed air dermatome on an aseptic area and with the same extent and depth in microns in all patients.
Immediately after the surgical procedure, a patch of cultured chimeric skin (experimental therapy) will be implanted in a half of the skin defect of the patient, and an occlusive non - adherent dressing (control) will be implanted in the other half.
Patients will initially be followed up every two days until epithelisation occurs (approximately 21 days after surgery) and at 3,8,and 12 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CX501 | Experimental | Drug: CX501Cultured chimeric skin |
| Non adherent dressing | Active comparator | Device: Occlusive non adherent dressingOcclusive non adherent dressing |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes over 28 days of age.
- Patients with recessive dystrophic epidermolysis bullosa diagnosed by clinical and historical criteria with severe skin syndactyly in whom reconstructive surgery is indicated.
- Patients whose legal guardians have given written informed consent for participation in the study before any study procedure is performed.
- Patients aged ≥ 12 years who have given written informed consent for participation in the study before any study procedure is performed.
Key exclusion criteria (9 listed)
- Women of childbearing age not using effective contraceptive methods (oral contraception)
- Pregnant or nursing women
- Documented or suspected hypersensitivity to any of the therapeutic agents included in the study, including anaesthetic drugs.
- Patients with a history of malignant tumor in the past 5 years
- Patients with a diagnosis of active tuberculosis at the time of recruitment
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 |
|---|---|---|
| CX501Cultured chimeric skin | Drug | CX501 |
| Occlusive non adherent dressingApplication of an occlusive non adherent dressing in the skin donor site | Device | Non adherent dressing |
Primary outcome
Time to epithelization
Time frame: 21 days
2 secondary outcomes
Fibroblast persistence
Time frame: 3, 8 and 12 months
Incidence of Adverse Events
Time frame: 12 months
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 1 Aug 2019.
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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.
Juan Carlos López, MD principal investigator
Hospital La Paz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CX501 and Occlusive non adherent dressing in people with EPIDERMOLYSIS BULLOSA, run by Tigenix S.A.U. at 2 sites in Spain.
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 4 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: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 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?
Time to epithelization (time frame: 21 days). 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 1 Aug 2019.