UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009428 |
|---|---|
| Receipt number | 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 10:12:03 |
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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
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
takedani@ims.u-tokyo.ac.jp
Sponsor or person
Institute
Research Hospital of the Institute of Medical Science
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011077
