UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061477 |
|---|---|
| Receipt number | R000070351 |
| Scientific Title | Study of manufacturing and quality control of bone regeneration therapy using human skeletal stem cell derived progenitors. |
| Date of disclosure of the study information | 2026/05/15 |
| Last modified on | 2026/05/07 17:34:14 |
* 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
Study of manufacturing and quality control of bone regeneration therapy using human skeletal stem cell derived progenitors.
Acronym
Study of manufacturing and quality control of bone regeneration therapy using human skeletal stem cell derived progenitors.
Scientific Title
Study of manufacturing and quality control of bone regeneration therapy using human skeletal stem cell derived progenitors.
Scientific Title:Acronym
Study of manufacturing and quality control of bone regeneration therapy using human skeletal stem cell derived progenitors.
Region
| Japan |
Condition
Condition
Apical Periodontitis / Radicular cyst
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Alveolar bone resected during apicoectomy procedures at the Department of Endodontics, Tohoku University Hospital will be used as samples, and cold runs will be conducted at the CPC within Tohoku University Hospital using established JASC isolation and culture techniques.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Is it possible to isolate and culture human skeletal stem cell-derived progenitor cells (JASC) within CPC from approximately 100 mg of alveolar bone fragments that would normally be discarded?
Key secondary outcomes
We will use sc RNA-seq to investigate whether the JASC cells cultured in isolation within the CPC are similar to those cultured in isolation in the laboratory.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Diagnosis: Apical periodontitis or radicular cyst
(2) Disease stage: The size of the radiolucent area on cone-beam CT scans is 2 mm or greater
(3) Age: 20 years or older and 70 years or younger (at the time of registration)
(4) Gender: Not restricted
(5) Participants who have provided written informed consent to participate in the study
Key exclusion criteria
(1) The shadow on dental X-rays or cone-beam CT scans is less than 2 mm in diameter
(2) Age under 20 or 71 or over (at the time of registration)
(3) Where the attending physician deems it inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Kamano |
Organization
Tohoku University Hospital
Division name
Endodontics
Zip code
9808575
Address
Seiryo-Machi 4-1, Aoba-Ku, Sendai, Miyagi
TEL
0227178343
yuya.kamano.e7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Kamano |
Organization
Tohoku University Hospital
Division name
Endodontics
Zip code
9808575
Address
Seiryo-Machi 4-1, Aoba-Ku, Sendai, Miyagi
TEL
0227178343
Homepage URL
yuya.kamano.e7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Clinical Research Ethics Committee
Address
Seiryo-Machi 1-1, Aoba-Ku, Sendai, Miyagi
Tel
0227284105
rinri-esct@tumail.tohoku.ac.jp
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
| 2026 | Year | 05 | Month | 15 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Approximately 100 mg of alveolar bone fragments (which are normally discarded) obtained during apicoectomy procedures on patients who have given their consent to participate in the study will be provided as samples.
Immediately after extraction, the samples will be stored in sterile saline solution prepared in Treatment Room 501 on the 5th floor of Building C at Tohoku University Hospital. They will then be transferred to the CPC within the Hospital Clinical Promotion Centre, where JASC cells will be isolated and cultured using a medium prepared with traceable components following collagenase treatment. Following cell isolation and culture, the sample is transferred to the Department of Conservative Dentistry, Graduate School of Dentistry, Tohoku University, where quality assessment via single-cell analysis and safety evaluations, such as sterility testing, are conducted.
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070351
