A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients.

A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients. - A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028366

Enrollment

Registered

2017-07-25

Start date

2017-06-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dystrophic epidermolysis bullosa

Interventions

ISN001, the sheet containing allogenic adipose derived mesenchymal stromal cells (1000000/sheet), is applied to the lesion(s) once a week up to 8 times

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients who are diagnosed with dystrophic epidermolysis bullosa according to the immunostaining test: (2)Patients with cutaneous ulcer size of 10 - 250cm2 (3)Patients with 50% or fewer changes in cutaneous ulcer size during the screening period

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

Measure	Time frame
Improvement in size of cutaneous ulcer at 5 weeks after the ISN001 application completion.	—

Secondary

Measure	Time frame
(1)Improvement of cutaneous ulcer size at every visit (2)Re-epithelization of the lesions treated (3)Over-all clinical efficacy assessment	—

Countries

Japan

Contacts

Public ContactKikuta Sadao

Ishin Pharmaceutical Co. Ltd., Clinical development department

kikuta@ishinpharma.co.jp03-6262-5243

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026