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Quality characterization data acquisition and manufacturing process validation with oral mucosal cell sheet cultivation

Quality characterization data acquisition and manufacturing process validation with oral mucosal cell sheet cultivation - Quality characterization data acquisition and manufacturing process validation with oral mucosal cell sheet cultivation

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018987
Enrollment
30
Registered
2015-11-30
Start date
2016-05-01
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

Healthy volunteer

Interventions

Tissue collection from oral mucosa A dentist is to collect the tissue from the subject. After applying local anesthetic to tissues peripheral to the collection sites, use a biopsy trephine (punch) t
1st time for informed consent, 2nd time for oral cleaning and check for infectious disease, and 3rd time for the managing operation site. Using oral mucosal sample, make a cell sheet and check the qu

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor
Foundation for Biomedical Research and Innovation
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy volunteer with written informed consent

Exclusion criteria

Exclusion criteria: 1. hematological complications 2. oral complications 3. fever with suspected infection 4. suggested ineligible from medical interview or screening 5. judged ineligible by doctor

Design outcomes

Primary

MeasureTime frame
Correlation data between diseminated cell number and quality of the cultivated cell sheet

Secondary

MeasureTime frame
- Correlation data between overall diameter of oral mucosal tissue acquired and cell number succeed in isolating - Correlation data between cultivation period and quality of the cultivated cell sheet - The histological characterization data for oral mucosal cell sheet (various immunostaining)

Countries

Japan

Contacts

Public ContactChie Sotozono

Kyoto Prefectural University of Medicine Department of Ophthalmology

csotozon@koto.kpu-m.ac.jp075-251-5577

Outcome results

None listed

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