UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027268 |
|---|---|
| Receipt number | R000031235 |
| Scientific Title | Alveolar bone regeneration with non-cultured autologous adipose cells (Phase I clinical study) |
| Date of disclosure of the study information | 2017/05/08 |
| Last modified on | 2023/05/01 09:46:46 |
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Basic information
Public title
Alveolar bone regeneration with non-cultured autologous adipose cells (Phase I clinical study)
Acronym
Alveolar bone regeneration with fresh isolated adipose cells
Scientific Title
Alveolar bone regeneration with non-cultured autologous adipose cells (Phase I clinical study)
Scientific Title:Acronym
Alveolar bone regeneration with fresh isolated adipose cells
Region
| Japan |
Condition
Condition
Severe alveolar bone atrophy
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether non-cultured autologous adipose-derived cells (NC-ADCs) can promote the alveolar bone augmentation induced by low-dose BMP2. NC-ADCs including high densities of stem/progenitor cells may possess a stronger bone regenerative capability and effectively reduce the amounts of rhBMP2 required to induce bone formation. The primary objective of this clinical study is to evaluate the safety, and the secondary objective is efficacy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety (occurrence of adverse events) for two-years after transplantation
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
| Medicine |
Interventions/Control_1
Non-cultured fresh isolated adipose cells;
1x10^7 are mixed to TCP and rhBMP2 as implants.
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. Patients who are partially or fully edentulous, and are required to treat by dental implants for prosthetic rehabilitation.
2. Patients who have insufficient bone height and/or width to place the dental implant
3. Patients who received the oral health care and maintain the good condition of Plaque Control.
4. The age of the patients: 20- to 70-years old
Key exclusion criteria
All patients are required to be nonsmokers.
2. Patients who have systemic disease, malignances, chronic infections, immune system abnormalities, septicemia, syphilis, HBV, HCV, HTLV-1, HIV, pregnancy, dementia.
3. Patients who have disorder of blood coagulation.
4. Patients who have hepatitis function disorders, metabolic bone disease or skeletal dysplasia.
5. Patients who needs the legal representative.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Asahina |
Organization
Nagasaki University Graduate School of Biomediacal Sciences
Division name
Department of Regenerative Oral Surgely
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, 852-8588, Japan
TEL
095-819-7704
y-sumig@nagaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Sumita |
Organization
Faculty of Dentistry, Nagasaki University
Division name
Basic and Translational Research Center for Hard Tissue Disease
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, 852-8588, Japan
TEL
095-819-7706
Homepage URL
y-sumita@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Regenerative Oral Surgely, Nagasaki University Graduate School of Biomediacal Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
none
Address
1-13-1 Kachidoki Chyuo-ku, Tokyo
Tel
+81 (0)3 5547 0203
office@rmda.or.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
| 2017 | Year | 05 | Month | 08 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031235
