Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents

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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