Clinical trial NCT04703751: Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents
Official title: Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dilated Cardiomyopathy
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical evaluation of the CIRCULATE catheter will be performed in a group of 10 patients. Each will receive intracoronary NTG followed by labelled CardioCell.

This is a non-randomized study without any requirement for sample size calculation.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Clinical evaluation of the CIRCULATE catheter involves intracoronary administration of a typical medical agent (nitroglycerin) and a shown-to-be-safe cell-based agent (CardioCell) in patients with a diagnosis of dilated cardiomyopathy (DCM).

Detailed description: The use of adult stem cells from several sources has been shown to improve cardiac function in acute and chronic cardiac disease. Several sources of adult stem cells have been identified including bone marrow, skeletal muscle, blood and adipose tissue. A number of pilot trials using intramyocardial injection of stem cells have shown promising results in patients with chronic myocardial disease in patients with ischemic heart failure , and in patients after an acute myocardial infarction .

The vast majority of research on cell therapies in the treatment of heart diseases focuses mainly on determining the optimal source of cells, their characteristics, and the number of cells in the administered preparation. From a clinical perspective, the method of cell administration is also an important topic.

There are several ways of cell administration that can be used in cell therapy for heart muscle disease. In addition to the intramuscular administration systems, such preparations can be administered directly into the circulation in a more or less selective manner. As no dedicated devices were developed, various types of catheters and microcatheters have been used for transcoronary administration. During the procedure of administering cell preparations by means of a catheter directly to the selected coronary vessel, the flow parameters should be adjusted to minimize the risk of damage to the administered cells.

The CIRCULATE catheter tested in the experiment was designed to increase the efficacy and safety of the cells delivery. It has a reservoir and holes created through which - as shown in preclinical studies - the cells can be delivered without a risk of their damage during delivery.

In addition to the administration of cell therapy, the course of the study is planned to administer the drug - nitroglycerin - one of the most commonly used drugs for coronary administration, recommended during standard angiography of the coronary arteries due to its ability to expand the arterial bed, thus enabling accurate imaging and sizing of the examined arteries.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of DCM
* Left ventricular ejection fraction (LVEF) ≤ 45% by echocardiography
* Signed informed consent

Exclusion Criteria:

* Less than 3 months from any substantial cardiac therapeutic intervention (such as, e.g. CRT/ICD fitting)
* Less than 3 months from acute coronary syndrome
* BMI lower than 18 or greater than 45kg/m2
* Severe valvular heart disease or left ventricle aneurysm requiring aneurysmectomy or other structural interventions
* Present candidate for heart transplantation
* Active or any history of malignancy or tumor
* Moderate or severe immunodeficiency
* Chronic immunosuppressive therapy
* Acute or chronic infection
* Coagulopathies
* Known alcohol or drug dependence
* Severe renal dysfunction (eGFR\<20mL/min)
* Soft tissue disease or local infection in a place of required artery puncture
* Pregnancy or breastfeeding
* Females of childbearing potential who do not use a highly effective method of contraception, and in absence of a negative highly sensitive urine or serum pregnancy test
* Participation in any other clinical research study that has not reached its primary efficacy endpoint or otherwise would interfere with the patient's participation in this project
* Life expectancy \<12 months
* Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study

Primary outcomes:
measure: Device success
timeFrame: During procedure
Secondary outcomes:
measure: Standardized uptake values (SUVs) of 99mTc-HMPAO radiolabelled CardioCell
timeFrame: 1 hour after application
measure: Freedom from major adverse cardiovascular events
timeFrame: 24 hours or until hospital discharge, whichever time point is first
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Department of Cardiac and Vascular Diseases, John Paul II Hospital
state: Maloplska
Study officials:
affiliation: The John Paul II Hospital
name: Piotr Musialek, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
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