UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024291 |
|---|---|
| Receipt number | 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 | 2021/01/09 22:53:10 |
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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
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
mmurata@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5944542/
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/sctm.20-0381
Number of participants that the trial has enrolled
6
Results
Five adult patients received MSC-CBT, and no adverse events related to intra-BM injection of MSCs were observed. All patients achieved neutrophil, reticulocyte, and platelet recoveries, with median times to recoveries of 21, 35, and 38 days, respectively. Grade II-IV acute GVHD did not develop in MSC-CBT patients. No patients developed chronic GVHD. At 1 year after transplantation, all MSC-CBT patients survived without relapse.
Results date posted
| 2021 | Year | 01 | Month | 08 | Day |
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
| 2016 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 11 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 04 | Day |
Last modified on
| 2021 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027681
