A prospective phase I/II study to evaluate the use of mesenchymal stromal (stem) cells for the treatment of skin disease in adults with recessive dystrophic epidermolysis bullosa

Phase 1

• Conditions: Recessive dystrophic epidermolysis bullosa; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-004500-30-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-22
• Study Completion: 2017-10-10
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1) Individuals with a diagnosis of RDEB confirmed by DNA analysis .
2) Individuals = 18 years and = 65 years of age, both male and female
3) Individuals that have voluntarily signed and dated an informed consent form (ICF) prior to the first study intervention
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Subjects who have had other investigational medicinal products within 90 days prior to screening or during the treatment phase.
2) Subjects who have received immunotherapy including oral corticosteroids for more than 1 week (intranasal and topical preparations are permitted).
3) Subjects with a known allergy to any of the constituents of the investigational product.
4) Subjects with a medical history or evidence of malignancy, including cutaneous squamous cell carcinoma.
5) Subjects who are pregnant or 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.
6) Subjects with both a) positive C7 ELISA and b) a positive indirect immunofluorescence (IIF) with binding to the base of salt split skin.

Study & Design

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