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

Phase 1

• Conditions: Recessive dystropic epidermolysis bullosa

• Registration Number: EUCTR2010-023121-38-GB
• Lead Sponsor: Intercytex Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified