UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001251 |
|---|---|
| Receipt number | R000001519 |
| Scientific Title | Distraction osteogenesis with transplantation of culture expanded bone marrow cells |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2012/01/17 08:49:30 |
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Basic information
Public title
Distraction osteogenesis with transplantation of culture expanded bone marrow cells
Acronym
Distraction osteogenesis with transplantation of culture expanded bone marrow cells
Scientific Title
Distraction osteogenesis with transplantation of culture expanded bone marrow cells
Scientific Title:Acronym
Distraction osteogenesis with transplantation of culture expanded bone marrow cells
Region
| Japan |
Condition
Condition
Skeletal dysplasia, Limb length discrepancy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To shorten the treatment period and reduce associated complications by accelerating new bone regenerates in distraction osteogenesis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Healing Index (days/cm)
Key secondary outcomes
Complications
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
| Maneuver |
Interventions/Control_1
Transplantation of culture expanded bone marrow cells
Interventions/Control_2
Control without cell therapy
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
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who undergo distraction osteogenesis and agree with this treatment
Key exclusion criteria
Patients who are planned to lengthen less than 3cm.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Ishiguro |
Organization
Nagoya University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550
TEL
052-741-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550
TEL
Homepage URL
Sponsor or person
Institute
Department of Orthopaedic Surgery, Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
| 2008 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Transplantation of culture expanded bone marrow cells shortened the treatment period and reduced associated complications by accelerating new bone regenerates. The femoral lengthening showed significantly faster healing than the tibial lengthening by the cell therapy.
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
| 2002 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 07 | Month | 15 | Day |
Last modified on
| 2012 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001519
