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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2021
• Main ID: NCT03418233
• Date of registration: 25/01/2018
• Prospective Registration: Yes
• Primary sponsor: John Paul II Hospital, Krakow
• Public title: Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in Patients With Chronic Ischaemic Heart Failure (CIHF)
• Scientific title: Regeneration of Ischemic Damages in Cardiovascular System Using Wharton's Jelly as an Unlimited Source of Mesenchymal Stem Cells for Regenerative Medicine. Project of the National Centre for Research and Development (Poland) 'STRATEGMED II'. Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in Patients With Chronic Ischaemic Heart Failure (CIHF)
• Date of first enrolment: April 19, 2018
• Target sample size: 115
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03418233
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Poland

Contacts

• Name: Piotr Musialek, MD, PhD
• Affiliation: John Paul II Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Females of childbearing potential who do not use a highly effective method of
contraception

- Females of childbearing potential in absence of a negative highly sensitive urine or
serum pregnancy test

- Participation in any other clinical research study that has not reached the primary
efficacy endpoint or otherwise would interfere with the patient's participation in
this project

- Life expectancy < 12 months

- Any objective or subjective reason for inability to attend follow-up visits

- Any concurrent disease or condition that, in the opinion of the investigator, would
make the patient unsuitable for participation in the project



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Drug: CardioCell

Drug: Placebos

Primary Outcome(s)

Left ventricle ejection fraction (LVEF) increase [Time Frame: 6 months FU]

Secondary Outcome(s)

Left ventricle ejection fraction (LVEF) change against baseline [Time Frame: 6 month FU]

Myocardial perfusion improvement [Time Frame: 6 month FU]

Left ventricle end-diastolic volume (EDV) change against baseline [Time Frame: 6 month FU]

Quality of life improvement [Time Frame: 6 month and 1 year FU]

An increase the result of 6 minute walk test [Time Frame: 3 and 6 month FU]

NT pro-BNP level [Time Frame: 3, 6 and 12 months FU]

Left ventricle end-systolic volume (ESV) change against baseline [Time Frame: 6 month FU]

An improvement the result of spiroergometric test [Time Frame: 6 month FU]

The occurrence of major adverse cardiovascular events [Time Frame: 6 month and 1 year FU]

Secondary ID(s)

CardioCell in CIHF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

KCRI

National Center for Research and Development, Poland