UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000423 |
|---|---|
| Receipt number | R000000507 |
| Scientific Title | Efficacy of mesenchymal stem cells for treatment of refractory acute GVHD after stem cell transplantation |
| Date of disclosure of the study information | 2006/06/01 |
| Last modified on | 2016/06/02 12:01:05 |
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Basic information
Public title
Efficacy of mesenchymal stem cells for treatment of refractory acute GVHD after stem cell transplantation
Acronym
Efficacy of mesenchymal stem cells for treatment of refractory acute GVHD
Scientific Title
Efficacy of mesenchymal stem cells for treatment of refractory acute GVHD after stem cell transplantation
Scientific Title:Acronym
Efficacy of mesenchymal stem cells for treatment of refractory acute GVHD
Region
| Japan |
Condition
Condition
refractoty acute GVHD after stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of mesenchymal stem cells for treatment of refractory acute GVHD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
GVHD score
Key secondary outcomes
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 |
Interventions/Control_1
Intravenous injection of 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) after stem cell transplantation
2) acute GVHD (grade III-IV)
3) refractory or relapsed acute GVHD after steroid therapy
4) written informed consent
5) HLA matched or one locus mismatched donor
Key exclusion criteria
1) in relapse disease status
2) in unconsciousness
3) in severe infection
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiya Ozawa |
Organization
Jichi Medical University
Division name
Division of Hematology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL
0285-58-7353
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Sato |
Organization
Jichi Medical University
Division name
Division of Hematology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL
0285-58-7353
Homepage URL
kazuya@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University, Department of Medicine, Division of Hematology
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University, Department of Medicine, Division of Hematology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2006 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2006 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 05 | Month | 29 | Day |
Last modified on
| 2016 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000507
