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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2010-023121-38-GB |
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Date of registration:
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26/11/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A prospective placebo controlled phase II study to evaluate the use of allogeneic fibroblasts for the treatment of skin erosions in recessive dystrophic epidermolysis bulllosa. - Fibroblast cell therapy for RDEB - a phase II clinical trial
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Scientific title:
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A prospective placebo controlled phase II study to evaluate the use of allogeneic fibroblasts for the treatment of skin erosions in recessive dystrophic epidermolysis bulllosa. - Fibroblast cell therapy for RDEB - a phase II clinical trial |
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Date of first enrolment:
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13/01/2011 |
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Target sample size:
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25 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023121-38 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Subjects who have a clinical diagnosis of recessive dystrophic epidermolysis bullosa. 2. Subjects who are =18 and = 50 years of age. 3. Subjects with at least 5 open skin erosions which are located on the limbs or the trunk, each with a surface area between 5cm2 and 50cm2. 4. Subjects who have voluntarily signed and dated an informed consent form prior to the first study intervention. 5. Subjects, who are able to understand the study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Subjects who have received immunotherapy or chemotherapy within 60 days of enrolment into this study. 2. Subjects with a known allergy to any of the constituents of the product. 3. Subjects with known or suspected malignancy. 4. Subjects with intolerance or allergy to additional study-associated drugs/therapies (e.g. anaesthetic etc). 5. Subjects who have taken systemic antibiotics within 7 days. 6. Subjects taking immunosuppressive therapy including systemic steroids (i.e., oral prednisolone >40mg for more than 1 week, intranasal/inhaled steroids are acceptable) within the 30 days of the first treatment or planning immunosuppressive therapy at any time during the study. 7. Subjects who have taken any other investigational product within 3 months prior to screening or planned use of any other investigational product during the study period. 8. Subjects who are pregnant, planning pregnancy and women of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase. 9. Subjects with abnormal laboratory findings considered clinically significant. 10. Subjects with a known history of poor adherence/compliance with medical treatment or follow up. 11. Subjects who are unable to understand the aims, objectives and follow-up treatment. 12. Subjects with known alcohol or narcotic drug dependence. 13. Subjects who have previously entered the study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Recessive dystropic epidermolysis bullosa
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Intervention(s)
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Trade Name: ICX-RHY-013
Product Name: Cultured allogeneic fibroblasts
Product Code: ICX-RHY-013
Pharmaceutical Form: Injection
INN or Proposed INN: Fibroblasts
Current Sponsor code: ICX-DEBRHY-2
Concentration unit: ml millilitre(s)
Concentration type: equal
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intradermal use
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Primary Outcome(s)
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Primary end point(s): To assess wound healing after intradermal injections of allogeneic fibroblasts in a single session with the primary endpoint of the trial being time to re-epithelialisation (closure of the skin wound).
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Main Objective: People suffering from the fragile skin disorder recessive dystrophic epidermolysis bullosa (RDEB) have wounds that are chronically inflamed, don't heal, progress to scarring and are at risk for turning into cancers - and there is no treatment. The main objective of this clinical trial is: to establish if skin cells called fibroblasts from unrelated donors (allogeneic) increase wound healing and skin function in subjects with RDEB.
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Secondary Objective: To compare wound healing over treated areas using wound surface area measurements and quality of life of the subjects taking part, including pain, wound recurrence and clinical safety.
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Secondary ID(s)
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ICX-DEBRHY-2
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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