Brief Title
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
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.
Study Type
Interventional
Primary Outcome
Device success
Secondary Outcome
Standardized uptake values (SUVs) of 99mTc-HMPAO radiolabelled CardioCell
Condition
Dilated Cardiomyopathy
Intervention
Transcoronary delivery of a pharmacological agent (nitroglycerin) and cell based agent (Cardiocell) using the CIRCULATE Catheter
Study Arms / Comparison Groups
CIRCULATE Catheter
Description: CIRCULATE Catheter will be used to deliver nitroglycerin and CardioCell to evaluate safety and efficacy of the device
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
10
Start Date
January 2021
Completion Date
September 2021
Primary Completion Date
July 2021
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Piotr Musialek, MD, DPhil, +48126142287, [email protected]
Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT04703751
Organization ID
CIRCULATE catheter evaluation
Responsible Party
Sponsor
Study Sponsor
John Paul II Hospital, Krakow
Study Sponsor
Piotr Musialek, MD, DPhil, Principal Investigator, The John Paul II Hospital
Verification Date
January 2021