UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005141 |
|---|---|
| Receipt number | R000006106 |
| Scientific Title | Evaluation on the manufacturing and quality control processes of cultivated autologous oral mucosal epithelial sheet |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2012/08/29 11:22:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation on the manufacturing and quality control processes of cultivated autologous oral mucosal epithelial sheet
Acronym
Cultivated autologous oral mucosal epithelial sheet
Scientific Title
Evaluation on the manufacturing and quality control processes of cultivated autologous oral mucosal epithelial sheet
Scientific Title:Acronym
Cultivated autologous oral mucosal epithelial sheet
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cultivated autologous oral mucosal epithelial sheet are manufactured by using the oral mucosal tissue harvested from healthy volunteers. The following items are evaluated on the epithelial sheet.
(1) The way of harvest of the oral mucosal tissue in terms of safety and the number of mucosal epithelial cells isolated from the tissue.
(2) Manufacturing and quality control protocols of cultivated autologous oral mucosal epithelial sheet.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirmation of the safety of harvest process of the oral mucosal tissue, and evaluation of manufacturing and quality control protocols.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
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 oral mucosal tissue is evaluated.
The oral mucosal tissue is harvested at the site opposite to the #6 tooth after local anesthesia. The size of the harvest tissue would be 5, 6 or 8 mm in diameter, and 3-4 mm in depth. Bleeding from the harvest site is stopped by either laser irradiation or suture. The harvest site is observed and checked during the follow-up period (a couple of weeks).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Kawamata |
Organization
Foundation for Biomedical Research and Innovation
Division name
Clinical Development Promotion Division
Zip code
Address
2-2 Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Foundation for Biomedical Research and Innovation
Division name
Clinical Development Promotion Division
Zip code
Address
2-2 Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
TEL
Homepage URL
Sponsor or person
Institute
Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Coordination, Support and Training Program for Translational Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
先端医療センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Cultivated autologous oral mucosal epithelial sheet are were manufactured by using the oral mucosal tissue harvested from healthy 16 volunteers.
The following results was confirmed.
(1) The way of harvest of the oral mucosal tissue in terms of safety.
(2) Manufacturing and quality control protocols of cultivated autologous oral mucosal epithelial sheet.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 25 | Day |
Last modified on
| 2012 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006106
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
