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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027268
Receipt No. 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 2018/11/08

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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
Middle name
Last name Izumi Asahina
Organization Nagasaki University Graduate School of Biomediacal Sciences
Division name Department of Regenerative Oral Surgely
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan
TEL 095-819-7704
Email y-sumig@nagaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Sumita
Organization Faculty of Dentistry, Nagasaki University
Division name Basic and Translational Research Center for Hard Tissue Disease
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan
TEL 095-819-7706
Homepage URL
Email y-sumita@nagasaki-u.ac.jp

Sponsor
Institute Department of Regenerative Oral Surgely, Nagasaki University Graduate School of Biomediacal Sciences
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 08 Day
Last follow-up date
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
2018 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031235

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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