Phase I study of MTC001 in patients with chronic ischemic heart failure

JRCT ID: jRCT2033210078

Registered date:10/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with chronic ischemic heart failure who are not eligible for left ventricular assist device
• Date of first enrollment: 25/07/2022
• Target sample size: 6
• Study type: Interventional

Intervention(s)

Myocardial biopsy.
Administration of clinical trial product to the borderzone of myocardial infarction by using a cell injection catheter

Outcome(s)

Primary Outcome

<Safety evaluation>
Major cardiovascular events

Secondary Outcome

<Tolerability evaluation>
Other cardiovascular events
<General safety evaluation>
Adverse events
<Efficacy evaluation>
Cardiac function evaluation
<Other evaluation>
Failures of regenerative medicine product or device

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1)Patients diagnosed with heart failure with old myocardial infarction as the underlying disease.
2)Patients with chronic ischemic heart failure with heart failure stage C and NYHA II or III (medical history of myocardial infarction at the time of informed consent).
3) Left ventricular ejection fraction (LVEF) 40% or less by echocardiography.
4)Patients who are not eligible for CRT or who show less than 5% LVEF improvement after 90 days or more of treatment.

Exclude criteria

1)Diabetic patients who have difficulty controlling their condition (HbA1c over 8.5%).
2)Patients with congenital enzyme abnormality and muscle disease.
3)Patients with active autoimmune disease
4)Patients with active malignant tumor. However, patients who have been diagnosed with complete remission and have not relapsed for 5 years or more (10 years or more for breast cancer) can be registered if it can be confirmed by systemic screening by CT / MRI etc. that there is no recurrence.
5)Female patients who are pregnant or may become pregnant.
6)Estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73 square meter, or serum creatinine is 3.0 mg/dL or more.
7)Hematocrit less than 25%
8)Patients receiving other gene therapy, cell therapy, etc. for severe heart failure within 2 years
9)Patients who have difficulty walking due to reasons other than heart failure (orthopedic diseases, etc.).
10)Patients with a history of serious allergies (contrast media allergy, status asthmaticus, anaphylactic shock, etc.).
11)Patients without ICD implantation despite the class I indication.
12)Patients with a history of appropriate ICD shock in the last 3 months.
13)Patients with a history of acute coronary syndrome in the last 3 months.

Related Information

• Primary Sponsor: Machino Takeshi
• Secondary Sponsor: Sato Akira,Metcela Inc.
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development