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Pivotal study about efficiency and safety of JTEC-01 made from revertant mosaicism in epidermolysis bullosa

Pivotal study about efficiency and safety of JTEC-01 made from revertant mosaicism in epidermolysis bullosa - Pivotal study of J-TEC-01 from revertant mosaicism for epidermolysis bullosa

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020734
Enrollment
3
Registered
2016-01-26
Start date
2016-01-25
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

recessive dystrophic epidermolysis bullosa or junctional epidermolysis bullosa

Interventions

transplanting of J-TEC-01 from revertant mosaicism to skin ulcer or erosion.

Sponsors

Hokkaido University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)patients diagnosed as severe recessive dystrophic epidermolysis bullosa or junctional epidermolysis bullosa (2)patients whose causative mutations are identified in COL7A1, COL17A1, LAMA3, LAMB3 or LAMC3. (3)patients who have one or more ulcers to be grafted with J-TEC-01 (4)patients who clinically have skin area with revertant mosaicism resistant to mechanical stimuli. (5)patients who have competence and from which we can obtain document consent (6)20 years of age or older

Exclusion criteria

Exclusion criteria: (1)patients who have allergy to particular antibiotics (Penicillin, Kanamycin, Amphotericin B) . (2)patients who have allergy to caw, mouse or pig. (3)patients who participate in other clinical trials within 6 month. (4)patients who have malignant tumor or past history of malignancy within 3years (except cutaneous malignancy). (5)those who are pregnant or nursing mum, or patients who are planning pregnancy during the study. (6)patients whom the investigators judge inappropriate as a subject for the study

Design outcomes

Primary

MeasureTime frame
the individual rate of epithelialization (%) at 4 week after the graft

Countries

Japan

Contacts

Public ContactYasuyuki Fujita

Hokkaido University Graduate School of Medicine Department of Dermatology

yfujita@med.hokudai.ac.jp+81-11-706-7387

Outcome results

None listed

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