UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004799 |
|---|---|
| Receipt number | R000005620 |
| Scientific Title | Fabrication test of 3D scaffold-free stem cell plug for cartilage regeneration by human adipose derived stem cell and myeloid stem cell |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2014/01/28 10:54:28 |
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Basic information
Public title
Fabrication test of 3D scaffold-free stem cell plug for cartilage regeneration by human adipose derived stem cell and myeloid stem cell
Acronym
Fabrication test of 3D scaffold-free stem cell plug for cartilage regeneration by human adipose derived stem cell and myeloid stem cell
Scientific Title
Fabrication test of 3D scaffold-free stem cell plug for cartilage regeneration by human adipose derived stem cell and myeloid stem cell
Scientific Title:Acronym
Fabrication test of 3D scaffold-free stem cell plug for cartilage regeneration by human adipose derived stem cell and myeloid stem cell
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the manufacturing process, quality and safety of stem cell plug for cartilage regeneration consisting of adipose derived stem cell or myeloid stem cell collected from healthy volunteers
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of fabrication of stem cell plug derived from human tissue
Key secondary outcomes
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Age:>=20 and <=60 years old at obtaining informed consent
2)Body fat percentage:>=20% for male, and >= 30% for female
3)Normal hematopoietic function
4)Suitable as a subject as results of screening test conducted after obtaining informed consent
5)Participate this trial based on subject's own free will and give informed consent in written form
Key exclusion criteria
1)Active or medical history of infectious disease within 3 months before registration
2)Past or present critical dysfunction of digestive organ, cardiovascular system, kidney, liver, or blood coagulation system
3)Positive for HBs antigen, HCV antibody, or HIV antibody
4)Blood sampling within 1 month or blood component sampling within 2 weeks before registration
5)Dosing anticoagulant agent
6)APTT >= 48 sec or PT >= 15sec
7)Cancer required treatment
8)Congenital or metabolic bone disease
9)Medical history of drug dependency or alcoholism
10)Participate other clinical research within 3 months before this trial
11)Medical history of drug hypersensitivity
12)Pregnant, capable of pregnancy and lactating women
13)Unsuitable for this trial judged by PI or SI
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Matsuda |
Organization
Faculty of Medicine, Kyushu university
Division name
Dept. of Orthopaedic Surg.
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Faculty of Medicine, Kyushu university
Division name
Dept. of Orthopaedic Surg.
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Faculty of Medicine, Kyushu university
Institute
Department
Personal name
Funding Source
Organization
New Energy and Industrial Technology Development Organization
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
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
| 2011 | Year | 01 | 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
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 | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the manufacturing process, quality and safety of stem cell plug for cartilage regeneration consisting of adipose derived stem cell or myeloid stem cell collected from healthy volunteers
Management information
Registered date
| 2010 | Year | 12 | Month | 27 | Day |
Last modified on
| 2014 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005620
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
