UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053400 |
|---|---|
| Receipt number | R000060944 |
| Scientific Title | Prospective study of indoleamine 2,3-dioxygenase activity by mesenchymal stem cell in acute GVHD treatment |
| Date of disclosure of the study information | 2024/01/22 |
| Last modified on | 2024/01/20 15:53:32 |
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Basic information
Public title
Prospective study of indoleamine 2,3-dioxygenase activity by mesenchymal stem cell in acute GVHD treatment
Acronym
Prospective study of indoleamine 2,3-dioxygenase activity by mesenchymal stem cell in acute GVHD treatment
Scientific Title
Prospective study of indoleamine 2,3-dioxygenase activity by mesenchymal stem cell in acute GVHD treatment
Scientific Title:Acronym
Prospective study of indoleamine 2,3-dioxygenase activity by mesenchymal stem cell in acute GVHD treatment
Region
| Japan |
Condition
Condition
acute graft-versus-host disease
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Mesenchymal stem cells (TEMCELL) are used to treat steroid-resistant acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation. One of the immunosuppressive mechanisms of TEMCELL is the activation of indoleamine 2,3-dioxygenase (IDO). IDO activity will be estimated by measuring tryptophan metabolites using serum from treated patients to determine the actual in vivo activity status of IDO with TEMCELL. To compare IDO activity with TEMCELL and its therapeutic effect on acute GVHD to determine the impact of IDO on acute GVHD control and the timing of the immunosuppressive effect of TEMCELL, leading to improved treatment of acute GVHD.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IDO activity at each measurement time point from the time of engraftment.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have undergone allogeneic hematopoietic stem cell transplantation and have neutrophil engraftment.
(2) Patients for whom serum from the time of engraftment is stored.
(3) Patients who are 16 years of age or older at the time of informed consent.
(4) Patients who are expected to receive systemic administration of steroids in case of Grade 2 or higher acute GVHD.
(5) Patients who may receive TEMCELL for the treatment of acute GVHD.
(6) Patients whose written informed consent for participation in this study is obtained.
Key exclusion criteria
(1) Patients with a history of previous administration of TEMCELL.
(2) Patients who are not scheduled to receive TEMCELL at the dosage and administration according to the attached document.
(3) Other patients who are judged to be unsuitable for the indication by the physician's judgment.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kitagawa |
Organization
Gifu municipal hospital
Division name
Hematology
Zip code
5008513
Address
7-1, Kashimacho, Gifu city, Gifu, Japan.
TEL
0582511101
jkitagawa1128@gmail.com
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Kitagawa |
Organization
Gifu municipal hospital
Division name
Hematology
Zip code
5008513
Address
7-1, Kashimacho, Gifu city, Gifu, Japan.
TEL
0582511101
Homepage URL
jkitagawa1128@gmail.com
Sponsor or person
Institute
Gifu municipal hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu municipal hospital
Address
7-1, Kashimacho, Gifu city, Gifu, Japan.
Tel
0582511101
chiken@gmhosp.gifu.gifu.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2024 | Year | 01 | Month | 20 | Day |
Last modified on
| 2024 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060944
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
