UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029824
Receipt number R000034074
Scientific Title Multicenter Study of TCD-51073(E) (Feasibility Study)
Date of disclosure of the study information 2017/11/06
Last modified on 2019/05/07 11:12:30

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Basic information

Public title

Multicenter Study of TCD-51073(E) (Feasibility Study)

Acronym

Feasibility Study of TCD-51073(E)

Scientific Title

Multicenter Study of TCD-51073(E) (Feasibility Study)

Scientific Title:Acronym

Feasibility Study of TCD-51073(E)

Region

Japan


Condition

Condition

Severe heart failure due to chronic ischemic heart disease

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Autologous skeletal myoblast sheet for dose response and tolerability after transplantation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Survival rate(Cardiac disease related death)

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Autologous skeletal myoblast sheet

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)Patients falling under any of the following with regard to the quality of the HeartSheet
1)When it is predicted that skeletal myoblasts do not satisfy the number of transplants assumed
2) In the sheet preparation confirmation test, when deviating from the standing time after sowing the cells
(2) Patient with tissue collection using collection / subculture kit of HeartSheet
(3) Patients who sign written informed consent prior to the clinical study
(4) Patients who are able to undergo all scheduled observations and consent to all details of the observations.

Key exclusion criteria

(1) Patients who do not have sheets
(2) Patients with a history of hypersensitivity to the components of the investigational product.
(3) Patient who can not open-heart surgery.
(4) Patients who are judged to be inappropriate for the study by the investigator or the sub investigators.

Target sample size

6


Research contact person

Name of lead principal investigator

1st name yoshiki
Middle name
Last name sawa

Organization

Osaka University Hospital

Division name

Cardiovascular surgery

Zip code

5650871

Address

2-15 Yamadaoka, Suita-shi, Osaka, Japan

TEL

06-6879-6090

Email

shiken@hp-crc.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name kazuo
Middle name
Last name tamada

Organization

Terumo Corporation

Division name

Clinical Development Department

Zip code

1631450

Address

Tokyo Opera City Tower 49F, 3-20-2, Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-6742-8500

Homepage URL


Email

Rinshokenkyu_HS@terumo.co.jp


Sponsor or person

Institute

Terumo Corporation

Institute

Department

Personal name



Funding Source

Organization

Terumo Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

-

Address

2-15 Yamadaoka, Suita-shi, Osaka, Japan

Tel

06-6210-8290

Email

shiken@hp-crc.med.osaka-u.ac.jp


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

2017 Year 11 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

2017 Year 09 Month 01 Day

Date of IRB

2017 Year 07 Month 19 Day

Anticipated trial start date

2017 Year 11 Month 06 Day

Last follow-up date

2021 Year 12 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

2017 Year 11 Month 04 Day

Last modified on

2019 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034074


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name