Investigation of cell therapy for recessive dystrophic epidermolysis bullosa (RDEB) in Australia through intradermal injection of allogeneic fibroblasts.

Phase 1

Completed

• Conditions: Recessive dystrophic epidermolysis bullosa; Skin - Dermatological conditions; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12610000760077
• Lead Sponsor: Research Infrastructure Support Services (RISS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Diagnosis of Recessive dystrophic epidermolysis bullosa- generalized severe (RDEB-GS) (patients should have detectable low levels of collagen VII expression and reduced / abnormal anchoring fibrils on electron microscopy).
2. At least 2 symmetric wounds on each side of the body (arms, chest/abdomen, legs) of approximately the same size (at least 4 cm2 as measured accurately by the Visitrak wound measurement system [Smith & Nephew Healthcare Ltd., Hull]).
3. Ability to sign informed consent, which indicates the investigational nature of this study.
4. Age: 18 years or older

Exclusion Criteria

1. Clinical evidence of local infection of the targeted wound(s).
2. Histopathologic evidence of malignancy (i.e. squamous cell carcinoma - SCC) of the targeted wound(s).
3. Use of systemic or topical steroid therapy within 30 days before enrolment.
4. Use of any investigational drug within the 30 days before enrolment.
5. Patients considered by the investigators to be unreliable or have poor compliance
6. Patients who are pregnant, or who suspect they may be pregnant at the time of the study and lactating women. Women of childbearing age should use effective contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified