UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Distraction osteogenesis with culture expanded bone marrow cells for patients with skeletal dysplasias and short stature
Title of the study (Brief title)	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	Hiroshi Kitoh
Organization	Nagoya University, Postgraduate School of Medicine
Division name	Department of Orthopaedic Surgery
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	Hiroshi Kitoh
Organization	Nagoya University, Postgraduate School of Medicine
Division name	Department of Orthopaedic Surgery
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 02 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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