UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012906
Receipt number R000015089
Scientific Title Development of treatment for severe heart failure using autologous myoblast sheet
Date of disclosure of the study information 2014/01/21
Last modified on 2018/09/18 14:49:31

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Basic information

Public title

Development of treatment for severe heart failure using autologous myoblast sheet

Acronym

Autologous myoblast sheets transplantation therapy for cardiomyopathy

Scientific Title

Development of treatment for severe heart failure using autologous myoblast sheet

Scientific Title:Acronym

Autologous myoblast sheets transplantation therapy for cardiomyopathy

Region

Japan


Condition

Condition

Dilated cardiomyopathy, Ischemic cardiomyopathy

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Safety, feasibility, and efficacy study of autologous myoblast sheet for cardiomyopasthy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

Improvement of LV ejection fraction

Key secondary outcomes

1) Feasibility of myoblast sheet implantation
2) Improvement of regional function
3) LV reverse remodeling
4) Improvement of symptoms and grade of heart failure
5) Adverse event


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment Behavior,custom
Maneuver

Interventions/Control_1

Culture of autologous skeletal myoblasts and engineering myoblast sheets. Transplantation of myoblast sheets to heart

Interventions/Control_2

Patients with maximal medical and surgical treatment

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) Dilated cardiomyopathy and ischemic cardiomyopathy
2) NYHA Class II,III, IV
3) Ejection fraction<35%

Key exclusion criteria

1) Severe skeletal muscle disease
2) Severe infection
3) Alcoholic or drug addiction in recent six months
4) Malignancy
5) Virus infection (HIV, HBV, HCV,HTLV)
6) Pregnancy
7) Others

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Sawa

Organization

Osaka University Graduate School of Medicine

Division name

Cardiovascular surgery

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3154

Email

sawa@surg1.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shigeru Miyagawa

Organization

Osaka University Graduate School of Medicine

Division name

Cardiovascular surgery

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3154

Homepage URL


Email

miyagawa@surg1.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine, Cardiovascular surgery

Institute

Department

Personal name



Funding Source

Organization

Research on Measures for Intractable Disease

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



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

大阪大学医学部付属病院


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 21 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

No longer recruiting

Date of protocol fixation

2013 Year 09 Month 17 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 22 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

2014 Year 01 Month 21 Day

Last modified on

2018 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015089


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name