Epidermolysis bullosa

7. EB clinical trials in Spain
As we have already explained, on a global level USA keeps being a pioneer in the number of clinical trials for EB with 54 trials registered (data extracted from the web www.clinicaltrials.gov). In Europe, out of the 19 countries having any clinical trial registered for EB, France is at the top of the ranking with 24 clinical trials, followed by United Kingdom with 11, Austria with 10, Germany with 9, and Spain with 7. In the following table we will briefly detail these 7 trials in a chronological order by its registry. In this table, you will see the name of the clinical trial, the year it was registered for the first time on the web and the clinical trial phase. It is also shown the current status of the trial, followed by the hospitals it took place in.
Name of the clinical trial | Year of registry | Phase of the clinical trial | Status | Place in Spain where it is done |
Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysis Bullosa | 2009 | Phase II | Completed | Mir-Mir Foundation, Barcelona La Paz Hospital, Madrid |
A Study of the Efficacy and Safety of ABH001 in the Treatment of Patients With Epidermolysis Bullosa Who Have Wounds That Are Not Healing | 2012 | Phase III | Finished | La Paz Hospital, Madrid |
ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa | 2015 | Phase III | Completed | La Paz Hospital, Madrid |
Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa | 2016 | Phase III | Finished | La Paz Hospital, Madrid |
Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa | 2017 | Phase III | Active, pending approval | Sant Joan de Déu Hospital, Barcelona Vall d’Hebron University Hospital, Barcelona La Paz Hospital, Madrid Viamed Sta. Ángela de la Cruz Hospital, Seville |
A Double-blind, Randomized, Intra-subject Placebo-controlled, Multicenter, Multiple Dose Study, Evaluating Safety, Proof of Mechanism, Preliminary Efficacy and Systemic Exposure in Subjects With Confirmed DDEB or RDEB Diagnosis With One or More Pathogenic Mutations in Exon 73 in the COL7A1 Gene | 2018 | Phase I/II | Waiting | La Paz Hospital, Madrid |
Safety Study and Preliminary Efficacy of Infusion Haploidentical Mesenchymal Stem Cells Derived From Bone Marrow for Treating Recessive Dystrophic Epidermolysis Bullosa | 2019 | Phase I/II | Completed | La Paz Hospital, Madrid |