UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007646 |
|---|---|
| Receipt number | R000008806 |
| Scientific Title | Distraction osteogenesis with culture expanded bone marrow cells for patients with skeletal dysplasias and short stature |
| Date of disclosure of the study information | 2012/04/05 |
| Last modified on | 2016/10/24 07:57:03 |
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Basic information
Public title
Distraction osteogenesis with culture expanded bone marrow cells for patients with skeletal dysplasias and short stature
Acronym
Distraction osteogenesis with culture expanded bone marrow cells
Scientific Title
Distraction osteogenesis with culture expanded bone marrow cells for patients with skeletal dysplasias and short stature
Scientific Title:Acronym
Distraction osteogenesis with culture expanded bone marrow cells
Region
| Japan |
Condition
Condition
skeletal dysplasias such as achondroplasia and limb length discrepancy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine accelerated new bone formation by transplantation of culture expanded bone marrow cells
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
healing index
Key secondary outcomes
infection, range of motion, callus formation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
patients with transplantation of culture expanded bone marrow cells
Interventions/Control_2
historical control without transplantation of culture expanded bone marrow cells
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
| Not applicable |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
shorter than -3SD or more than 3cm of limb length discrepancy
Key exclusion criteria
less than 20kg of body weight
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitoh |
Organization
Nagoya University, Postgraduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
65 Tsurumai-Cho, Showa, Nagoya Aichi 466-8550
TEL
052-741-2111
hkitoh@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitoh |
Organization
Nagoya University, Postgraduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
65 Tsurumai-Cho, Showa, Nagoya Aichi 466-8550
TEL
052-741-2111
Homepage URL
hkitoh@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in Aid for Scientific Research from Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2012 | Year | 04 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | 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
| 2012 | Year | 04 | Month | 02 | Day |
Last modified on
| 2016 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008806
