A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients.
- Conditions
- dystrophic epidermolysis bullosa
- Registration Number
- JPRN-UMIN000028366
- Lead Sponsor
- Ishin Pharmaceutical Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Not provided
(1)Patients with the following medical histories. 1)Patients who are being suffered from squamous cell carcinoma except more than one year has passed without relapses following surgical operations. 2)Patients with severe allergic reactions such as shock and/or anaphylaxis clinical symptoms 3)Patients with skin hypersensitivities against topically applied medicines. 4)Patients with allergies against xenogeneic proteins 5)Patients with allergies against penicillin, streptomycin and/or amphotericin B. 2) Patients with the following complications. 1) Severe functional failures in the liver, heart and/or lung. (3)Patients who underwent the following conditions within one year of the day of initiation of this study. 1) Drug abuses 2) Alcohol dependencies (4)Patients who participated in other clinical trials and/or intervention studies within 4 months (120 days) of the day of initiation of this study. (5)Patients who are considered not suitable for the study by principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method