Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in Patients With Chronic Ischaemic Heart Failure (CIHF)

NCT03418233 | Completed Phase 2 DMC

• 1 other identifier: CardioCell in CIHF
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 5

Brief Summary

The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will receive the placebo.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Left ventricle ejection fraction (LVEF) increase

  Left ventricle ejection fraction (LVEF) increase, assessed by SPECT at 6M FU vs. during index (baseline) imaging - comparison between two groups (active vs placebo therapy).

  6 months FU

Secondary Outcomes (10)

• An increase the result of 6 minute walk test

  3 and 6 month FU

• Myocardial perfusion improvement

  6 month FU

• Myocardial perfusion improvement

  6 month FU

• An improvement the result of spiroergometric test

  6 month FU

• Left ventricle ejection fraction (LVEF) change against baseline

  6 month FU

Study Arms (2)

Active Group

ACTIVE COMPARATOR

Patients randomized to the active treatment group: Transcoronary or trans-bypass graft administration of CardioCell consist 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin) will be performed using a dedicated cell delivery catheter. The cell delivery catheter is a typical coronary balloon catheter that is CE marked (1.2x10 mm balloon, RX system) modified to include cell delivery perforations in the balloon section of the catheter. The cell delivery catheter has been demonstrated not to affect cell viability or other cell properties.

Drug: CardioCell

Control Group

PLACEBO COMPARATOR

Patients randomized to the placebo group will receive Placebos consist 0.9% NaCl and 5% albumin injections (in the same volumes as CardioCell) via the coronary arter(ies)/bypass grafts. The CardioCell and placebo are distributed encoded, in an indistinguishable form.

Drug: Placebos

Interventions

CardioCell DRUG

Patients randomized to the active treatment group will receive transcoronary or trans-bypass graft administration of 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin). Injection will be performed using a dedicated cell delivery catheter. The cell delivery catheter is a typical coronary balloon catheter that is CE marked (1.2x10 mm balloon, RX system) modified to include cell delivery perforations in the balloon section of the catheter. The cell delivery catheter has been demonstrated not to affect cell viability or other cell properties.

Also known as: CardioCell administration

Active Group

Placebos DRUG

Patients randomized to the placebo group will receive Placebos consist 0.9% NaCl and 5% albumin injections (in the same volumes as CardioCell) via the coronary arter(ies)/bypass grafts. The CardioCell and placebo are distributed encoded, in an indistinguishable form.

Also known as: Placebo administration

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years
• Diagnosis of ischemic heart failure (supported by history of CAD or revascularization by PCI or CABG procedure) without known need for revascularization or feasibility of revascularization
• Substantial chronic ischemic myocardial injury as demonstrated by LVEF ≤45% by SPECT and the clinical stage of NYHA II or III
• At least 50% viable myocardium (SPECT)
• Patency of at least two major coronary arteries and/or bypass grafts supplying their territories (confirmed in angiography within 12 months)
• Clinically stable CIHF for at least 3 months on guideline recommended therapy
• Signed informed consent

You may not qualify if:

• Other than ischemic cause of cardiomyopathy
• Less than 3 months from any substantial therapeutic intervention (such as, e.g. CRT/ICD fitting or revascularization)
• Less than 3 months from ACS
• BMI lower than 18 or greater than 45kg/m2
• Severe valvular heart disease or left ventricle aneurysm requiring aneurysmectomy or other structural interventions
• 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

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead
• KCRI: collaborator
• National Center for Research and Development, Poland: collaborator

Study Sites (5)

Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

Katowice, 04-628, Poland

Location

Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice

Katowice, 40-635, Poland

Location

The John Paul II Hospital

Krakow, 31-202, Poland

Location

The University Hospital in Cracow

Krakow, 31-501, Poland

Location

Central Clinical Hospital of the MSWiA in Warsaw

Warsaw, 02-507, Poland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Piotr Musiałek, MD, PhD

  John Paul II Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Data and Safety Monitoring Board (DSMB) will be blinded at project start, but may request unblinding if necessary to accommodate effective review of data. Other than the DSMB (if necessary), the only other "un-blinded parties", meaning that they will have knowledge as to the patient's treatment assignment, will be the PBTiK UJ CM employee who participates in randomization utilizing randomization lists and investigational medication preparation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The CIHF trial will enroll 105 patients with randomization into active and placebo therapy with 2:1 ratio. Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded fashion, labelled CardioCell to determine the early myocardial uptake and retention of IMP.

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 1, 2018
• Study Start: April 19, 2018
• Primary Completion: January 27, 2021
• Study Completion: March 31, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

PL (5)