UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038810
Receipt number 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 16:16:13

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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 or person

Institute

Aichi Medical University

Institute

Department

Personal name



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

Value
https://center6.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