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epidermise sheet cultured from autologous revertant somatic mosaic site

Treatment of epidermolytic ichthyosis using epidermise sheet (Jace) cultured from autologous revertant somatic mosaic site - epidermise sheet cultured from autologous revertant somatic mosaic site

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTb041190097
Enrollment
3
Registered
2019-12-19
Start date
2020-03-03
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

epidermolytic ichthyosis

Interventions

Transplantation of cultured epidermis sheet

Sponsors

Akiyama Masashi
Lead Sponsor
Japan Agency for Medical Research and Development (AMED)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are diagnosed with epidermolytic ichthyosis and have a revertant somatic mutation, the responsible gene mutation * was identified by genetic testing. * Heterozygote mutation must be demonstrated in either keratin 1 (KRT1) or keratin 10 (KRT10).

Exclusion criteria

Exclusion criteria: Patients hypersensitive to penicillin, kanamycin, streptomycin, and amphotericin B antibiotics. Patients with a history of hypersensitivity to penicillin antibiotics and aminoglycoside antibiotics. Patients who are allergic to cattle, mice and pigs. Patients with malignant neoplastic lesions other than the skin, or patients with a history within 3 years prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Improvement rate of hyperkeratosis 4 weeks after the final transplant (%)

Secondary

MeasureTime frame
Improvement rate of site-specific hyperkeratosis 4 weeks after final transplantation (%) Average improvement rate of hyperkeratosis up to 24 weeks after initial transplantation (%) Average improvement rate of site-specific hyperkeratosis up to 24 weeks after initial transplantation (%)

Countries

Japan

Contacts

Public ContactHironobu Takahashi

Nagoya University Hospital

Iga-shinsa@adm.nagoya-u.ac.jp+81-52-744-2479

Outcome results

None listed

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