UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006175 |
|---|---|
| Receipt number | R000007298 |
| Scientific Title | Safety and efficacy of the intra-bone marrow cord blood transplantation |
| Date of disclosure of the study information | 2011/09/30 |
| Last modified on | 2024/02/23 15:08:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety and efficacy of the intra-bone marrow cord blood transplantation
Acronym
Safety and efficacy of the intra-bone marrow cord blood transplantation
Scientific Title
Safety and efficacy of the intra-bone marrow cord blood transplantation
Scientific Title:Acronym
Safety and efficacy of the intra-bone marrow cord blood transplantation
Region
| Japan |
Condition
Condition
hematological diseases
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and efficacy of intra-bone injection of cord blood cells
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adverse effects related intra-bone injection of cord-blood cells, engraftment rate of netrophil and platelet
Key secondary outcomes
Regimen-related toxicity, disease-free survival, over-all survival, non-relapse mortality, relapse rate, incidence of infection, rate and severity of acute GVHD, number of neutrophil and platelet on day 50 and day 100
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intra-bone marrow injection of cord blood 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving cord-blood transplantation
Key exclusion criteria
none
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Chiba |
Organization
University of Tsukuba
Division name
Department of Hematology
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Kurita |
Organization
University of Tsukuba
Division name
Department of Hematology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
University of Tsukuba, Department of Hematology
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba, Department of Hematology
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 09 | Month | 30 | 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
| 2011 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | 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
| 2011 | Year | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007298
