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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009428
Receipt No. R000011077
Scientific Title Clinical trial of regenerative medicine for hemophilic arthropathy using human mesenchymal stem cells
Date of disclosure of the study information 2013/04/01
Last modified on 2020/12/09

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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/ctr_e/ctr_view.cgi?recptno=R000011077

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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