臨床研究等提出・公開システム

Phase I investigator-initiated study of the safety of MTC001 in patients with chronic ischemic heart failure

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

Machino Takeshi

University of Tsukuba Hospital

2-1-1, Amakubo, Tsukuba-shi, Ibaraki, 305-8576, Japan

machino@md.tsukuba.ac.jp

Hashimoto Koichi

University of Tsukuba

2-1-1, Amakubo, Tsukuba-shi, Ibaraki, 305-8576, Japan

+81-29-853-3326

koichi.hashimoto@md.tsukuba.ac.jp

Suspended

June. 01, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Patients with chronic ischemic heart failure who are not eligible for left ventricular assist device

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

Heart Failure, Chronic heart failure

catheter

D006333

D057785

<Safety evaluation>
Major cardiovascular events

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

+81-29-853-3914

Mar. 09, 2021

none