UMIN-CTR Clinical Trial

Public title

Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease.

Acronym

Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease.

Scientific Title

Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease.

Scientific Title:Acronym

Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease.

Region

Japan

Condition

Severe heart failure due to chronic ischemic heart disease

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This multicenter study validates the primary outcome measure, investigates the safety and efficacy, and investigates feasibility of delivery method of the investigational product.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in LVEF at 26 weeks after the transplantation.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients who are chronic ischemic heart disease.
(2) Patients who are classified as NYHA class 3 or 4.
(3) Patients who are heart failure even under maximal oral medication including digitalis, diuretic, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, aldosterone antagonist and oral inotropic agents.
(4) Patients of 20 years or more at the time of obtaining informed consent.
(5) Patients who are concerned with worsening heart failure even though standard treatments such as CABG, mitral valvuloplasty, surgical ventricular restoration, CRT, and PCI were conducted over 3 months ago .
(6) Patients who have less than LVEF 35 percent determined by echocardiography at rest.
(7) Patients who provide first-person informed consent.
(8) Patients who are expected to be resident in Japan about two years after obtaining informed consent.

Key exclusion criteria

(1) Patients who have signs of skeletal muscle disease.
(2) Patients under treatment with thyroid hormone.
(3) Patients with infectious disease(HIV,HBV,HCV,HTLV1).
(4) Patients in shock due to worsening heart failure.
(5) Patients with intercurrent cardiovascular abnormalities that are judged to affect the clinical trial by the investigator or the sub investigators.
(6) Patients with irreversible organ failure other than the heart.
(7) Patients with a malignant tumor.
(8) Patients who are pregnant or possibly pregnant.
(9) Patients who cannot receive a blood transfusion.
(10) Patients with a history of drug addiction or alcohol addiction within 6 months before obtaining informed consent.(11) Patients with hypersensitivity to antibiotics or animal origin materials such as fetal bovine serum.
(12) Patients with severe pulmonary hypertension.
(13) Patients with a history of other clinical study within 6 months.
(14) Patients who are judged to be inappropriate for the study by the investigator or the sub investigators.

Target sample size

6

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiki Sawa

Organization

Osaka University Hospital

Division name

Cardiovascular surgery

Zip code

Address

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

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Terumo Corporation

Division name

Clinical Development Department

Zip code

Address

TEL

0465-81-4104

Homepage URL

Email

kazuo_tamada@terumo.co.jp

Institute

Terumo Corporation

Institute

Department

Personal name

Organization

Terumo Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

05

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

02

Month

27

Day

Date of IRB

Anticipated trial start date

2012

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

05

Month

22

Day

Last modified on

2014

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009426