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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038810
Receipt No. R000044251
Scientific Title clinical study to evaluate the safety o f intra-bone marrow cotransplantation o f adipose -derived mesenchymal stromal cells and cord blood cells
Date of disclosure of the study information 2019/12/06
Last modified on 2019/12/06

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Basic information
Public title safety study on co -transplantation o f adipose
-derived mesenchymal stromal cell and cord
blood cells
Acronym iCTAC
Scientific Title clinical study to evaluate the safety o f intra-bone marrow cotransplantation o f adipose -derived mesenchymal stromal cells and cord blood cells
Scientific Title:Acronym iCTAC
Region
Japan

Condition
Condition hematological disorders to be applied to cord blood cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety of co -transpantation of adipose
-derived mesenchymal stromal cell and cord
blood cells in the setting of cord blood cell transplantation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Adverse events related to bone marrow injection of mesenchymal stromal cells within 14 days after transplantation, other adverse events, death and project withdrawal related to adverse event.
Key secondary outcomes 1. engraftment rate , time for recovery of blood cell counts
2. adverse events up to 28 days after transplantation.
3. incidence and severity o f acute GVHD.
4. incidence and severity o f chronic GVHD.
5. treatment-related mortality at day 100 and
1year after transplantation
6. recurrence rate o f the disease at 1 year after transplantation
7. survival rate and disease free survival up
to 1 year after trans plantation.
8. incidence of infection

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 intra bone marrow of adipose-derived mesenchymal stromal cells and 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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with hematological disorders to be applied to cord blood cell transplantation.
2. Patient aged from 20 to 70 years
3. The disease is under complete remission (except for MDS).
4. Patients undergoing cord blood trans plantation.
5. Patients with agreements with the documents of this study.
6. Performance status is below 2.
7. Cord blood is available from cord blood center.
8. Patient with favorable organ functions .
ejection fraction > 40%
% F EV1.0 > =60 and % VC >= 50
AST / ALT < 5 X ULN
serum creatinine < 3 X ULN
Key exclusion criteria 1. Patients with HIV infection.
2. Patients with treatment o f Gemtuzumab ozogamicin (within 6 mo nth).
3. Patients with pregnancy, breast feeding or possibility o f pregnancy.
4. Patients with uncontrollable mental illness .
5. Patients with treatment-resistant infection.
6. Patients with drug allergy to wards anti-cancer drug s or immunosuppressants .
7. Patients who had another transplantation within 12 months .
8. Other conditions considered not suitable for the study by doctors .
Target sample size 9

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Nakayama
Organization Aichi Medical University Hospital
Division name Department of Clinical Laboratory
Zip code 480-1195
Address 1-1, Karimata, Yazako, Nagakute, Aichi, Japan
TEL 0561-62-3311
Email tnaka@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Hidefumi
Middle name
Last name Kato
Organization Aichi Medical University Hospital
Division name Department of Blood Transfusion and Cell Therapy
Zip code 480-1195
Address 1-1, Karimata, Yazako, Nagakute, Aichi, Japan
TEL 0561-62-3311
Homepage URL
Email hkato@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization Aichi Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Certified Special Committee for Regenerative Medicine
Address 4-1-1, Sannomaru, Nakaku, Nagoya, Aichi, Aichi, Japan
Tel 052-951-1111
Email 311-rmr@nnh.hosp.go.jp

Secondary IDs
Secondary IDs YES
Study ID_1 R2017-001
Org. issuing International ID_1 NA8170001
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 愛知医科大学病院

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 06 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 Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 21 Day
Date of IRB
2018 Year 02 Month 09 Day
Anticipated trial start date
2019 Year 11 Month 27 Day
Last follow-up date
2023 Year 12 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 06 Day
Last modified on
2019 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044251

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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