Allogeneic fibroblast cell therapy for dystrophic epidermolysis bullosa

Phase 2

Completed

• Conditions: Dystrophic epidermolysis bullosa (DEB); Skin and Connective Tissue Diseases; Epidermolysis bullosa

• Registration Number: ISRCTN67757229
• Lead Sponsor: Intercytex Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-29
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Subjects who have a clinical diagnosis of dystrophic epidermolysis bullosa, either autosomal recessive or autosomal dominant
2. Subjects who are =16 and =70 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 5cm sq and 50cm sq. The size of these erosions must not exceed 50cm^2 at baseline
4. Subjects who have voluntarily signed and dated an Informed Consent Form (ICF) prior to the first study intervention
5. Subjects, who are, in the opinion of the Investigator, 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

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 90 days 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 been screened on more than two occasions, or who have previously been treated under this protocol
14. Subjects who have previously been treated with ICX-RHY-013 and who have an immune response for collagen VII antibody detected by immunofluorescence

Study & Design

• Study Type: Interventional
• Study Design: Not specified