UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of regenerative medicine for hemophilic arthropathy using human mesenchymal stem cells
Acronym	Regenerative medicine for hemophilic arthropathy
Scientific Title	Clinical trial of regenerative medicine for hemophilic arthropathy using human mesenchymal stem cells
Scientific Title:Acronym	Regenerative medicine for hemophilic arthropathy
Region	Japan

Condition
Condition	Hemophilic knee arthropathy
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Establishment on novel therapy for hemophilic arthropathy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety of the transplanted patients
Key secondary outcomes	1)repair of cartilage evaluated by MRI 2)Improvement of clinical symptoms and joint function

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Joint infusion of human mesenchymal stem cells
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	40 years-old >=
Gender	Male
Key inclusion criteria	progressive hemophilic knee arthropathy non-inhibitor covered with prophylaxis treatment
Key exclusion criteria	DM Antibody(+) of HCV, HIV liver dysfunction anemia renal dysfunction drug allergy
Target sample size	5

Research contact person
Name of lead principal investigator	1st name hideyuki Middle name Last name takedani
Organization	Department of Joint Surgery
Division name	Research Hospital of the Institute of Medical Science The University of Tokyo
Zip code	1088639
Address	minatoku
TEL	0334438111
Email	takedani@ims.u-tokyo.ac.jp

Public contact
Name of contact person	1st name hideyuki Middle name Last name takedani
Organization	IMUST hosipital
Division name	Research Hospital of the Institute of Medical Science The University of Tokyo
Zip code	1088639
Address	minatoku
TEL	0334438111
Homepage URL
Email	takedani@ims.u-tokyo.ac.jp

Sponsor
Institute	Research Hospital of the Institute of Medical Science The University of Tokyo
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Hospital of the Institute of Medical Science The University of Tokyo
Address	4-6-1 Shiroganedai, Minato-ku, Tokyo
Tel	+81334438111
Email	takedani@ims.u-tokyo.ac.jp

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	東京大学医科学研究所附属病院

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	9
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	2013 Year 03 Month 31 Day
Date of IRB	2014 Year 08 Month 25 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 11 Month 29 Day
Last modified on	2020 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011077