UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007646
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hkitoh@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008806

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.