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Sealing of lung air leaks by autologous tissue engineered dermal fibroblast sheets

Sealing of lung air leaks by autologous tissue engineered dermal fibroblast sheets - Sealing of lung air leaks by fibroblast sheets

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022554
Enrollment
5
Registered
2016-07-01
Start date
2016-07-01
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

Pneumothorax, Bullae, Benign lung tumors

Interventions

A minimum of skin tissue and peripheral blood required for fibroblast sheets is collected from a research participant. A fibroblast sheet is doubly transplanted on to the site of lung air leaks after

Sponsors

Tokyo Women's Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 A case of 20 years or older 2 The patients will undergo operation of lung resection and/or pleurectomy 3 A self-skin tissue is available for a cell processing without a functional invasive. 4 The functions of the main organs such as bone marrow, heart, liver, and kidney are kept. Within 2 weeks before registration, the criteria are follows. 1) White blood cell count >=3000mm3-<=12000mm3, 2) Neutrophil count >=1500mm3-<=5000mm3, 3) Hemoglobin >=8g/dL, 4) Platelet count >=50000mm3, 5) Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT); 2.5 times upper limit of normal in our hospital, 6) Creatinine; 1.5 times upper limit of normal in our hospital 5 A case that a document agreement by the person himself was provided about examination participation.

Exclusion criteria

Exclusion criteria: 1 Patient with infectious disease (HBV, HCV, HIV, HTLV, syphilis) 2 Patients with the impossible of sealing of air leaks 3 Pregnancy and the possibility of the pregnancy 4 Patients with allergy (lidokin and antibiotics) 5 Patients with psychiatric diseases 6 Patients with skin diseases 7 Patients with severe or complicated medical conditions, not allowing participation into this protocol

Design outcomes

Primary

MeasureTime frame
The safety of the autologous tissue engineered cell sheets

Countries

Japan

Contacts

Public ContactRyo Takagi

Tokyo Women's Medical University Institute of Advanced Biomedical Engineering and Science

takagi.ryo@twmu.ac.jp03-5367-9945

Outcome results

None listed

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