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Evaluation on the manufacturing and quality control processes of cultivated autologous oral mucosal epithelial sheet

Evaluation on the manufacturing and quality control processes of cultivated autologous oral mucosal epithelial sheet - Cultivated autologous oral mucosal epithelial sheet

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005141
Enrollment
20
Registered
2011-03-01
Start date
2011-01-01
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 volunteers

Interventions

Harvest of the oral mucosal tissue is conducted at the examination room of the Odontology Department of Institute of Biomedical Research and Innovation Hospital. The safety of harvest process of the o

Sponsors

Foundation for Biomedical Research and Innovation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy volunteers that are 20 years old or more, and less than 50 years old. 2) Those who can participate in this research based on his or her own free will, and give informed-consent in written form. 3) Those who are considered to be suitable as subjects for this research as a result of the screening examination conducted after obtaining informed-consent.

Exclusion criteria

Exclusion criteria: 1) Those who are positive for HBs antigen, HCV antibody, or HIV antibody. 2) Those who have any diseases that require treatment. 3) Those who have medical history of drug hypersensitivity. 4) Those who are judged to be unsuitable for this research by medical doctors.

Design outcomes

Primary

MeasureTime frame
Confirmation of the safety of harvest process of the oral mucosal tissue, and evaluation of manufacturing and quality control protocols.

Countries

Japan

Outcome results

None listed

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