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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024291
Receipt No. R000027681
Scientific Title Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells
Date of disclosure of the study information 2016/12/01
Last modified on 2018/04/09

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Basic information
Public title Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells
Acronym Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells
Scientific Title Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells
Scientific Title:Acronym Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells
Region
Japan

Condition
Condition Hematological disorder
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells (MSCs) generated from bone marrow of third-party donor
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Infusional toxicity of MSCs within 14 days after transplantation
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 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 MSCs generated from bone marrow of third-party donor 4 hours before cord blood transplantation
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Hematological disorder eligible for cord blood transplantation
2. Age: 20 years or older
3. Malignant cells in bone marrow: less than 70%
4. Patient's agreement to participate in this study
5. Performance status (ECOG): 0 to 2
6. Cord blood unit: HLA-A, B, DR serotypes 4/6 match, total nuclear cell count at 1.5 x 10e7/kg or higher, prioritize cord blood unit containing more CD34 positive cells
7. Ejection fraction: 40% or higher, %FEV1.0: 60% or higher, %VC: 50% or higher, AST/ALT: less than 5 x ULN, serum creatinine: less than 3 x ULN
8. MSC donor: spouse or relative within the fourth degree of relationship
Key exclusion criteria 1. Positive for HIV-Ab
2. Administration of gemtuzumab ozogamicin within 6 months
3. In pregnancy or breast-feeding
4. Uncontrolled psychiatric disorder
5. Uncontrolled infectious disease
6. Allergy to drugs for transplant preconditioning or GVHD prophylaxis
7. Re-transplantation within 1 year from the preceding transplantation
8. Doctor's decision
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Kiyoi
Organization Nagoya University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2141
Email kiyoi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Murata
Organization Nagoya University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2145
Homepage URL
Email mmurata@med.nagoya-u.ac.jp

Sponsor
Institute Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
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
Address
Tel
Email

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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 04 Day
Last modified on
2018 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027681

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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