UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011286 |
|---|---|
| Receipt number | R000013222 |
| Scientific Title | Safety investigations for the bone regenerative medicine using growth factors secreted from the patients' own stem cells |
| Date of disclosure of the study information | 2013/07/27 |
| Last modified on | 2016/08/10 10:37:53 |
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Basic information
Public title
Safety investigations for the bone regenerative medicine using growth factors secreted from the patients' own stem cells
Acronym
Bone regeneration using the condition media from stem cells
Scientific Title
Safety investigations for the bone regenerative medicine using growth factors secreted from the patients' own stem cells
Scientific Title:Acronym
Bone regeneration using the condition media from stem cells
Region
| Japan |
Condition
Condition
Bone defects due to removal of teeth, Periodontitis
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety investigations of bone regeneration using stem cell derived growth factors
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
No complicatons and side effects will be seen 6 month after application
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
MSC-CM group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients after tooth extraction
Patients who have periodontal pockets (over 4mm) after initial periodontal therapy
Key exclusion criteria
Patients who have contraindications for any surgery
Patients who have bone metabolic disease such as osteoporosis, diabetes and neoplasms
Patients who are treating with bisphosphonate or who have a history of treatment by BPs.
Patients who are pregnancy, suspected pregnancy or breast-feeding
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Ueda |
Organization
Nagoya University Hospital
Division name
Oral and Maxillofacial Surgery
Zip code
Address
65, Tsuruma-Cho, Showa-ku, Nagoya, Japan
TEL
052-742348
w-kat@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Katagiri |
Organization
Nagoya University Hospital
Division name
Oral and Maxillofacial Surgery
Zip code
Address
65 Tsuruma-cho, Showa-ku,
TEL
052-744-2348
Homepage URL
w-kat@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Granis-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2011 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 26 | Day |
Last modified on
| 2016 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013222
