Recessive dystropic epidermolysis bullosa
Conditions
Interventions
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
Conce
Sponsors
Intercytex Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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). | — |
Countries
United Kingdom
Outcome results
None listed