Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI)

NCT03404063 | Completed Phase 2 DMC

• 1 other identifier: CardioCell evaluation in AMI
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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 be treated by the administration of placebo during the sham procedure.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Reduction of infarct size

  Reduction of infarct size assessed in cardiac MRI during index hospitalization and in 6 month FU between two groups (active vs sham).

  Index hospitalization and in 6 month FU

Secondary Outcomes (10)

• Infarct size reduction

  6 month FU

• Myocardial perfusion improvement

  6 month FU

• Myocardial perfusion improvement

  6 month FU

• Increase of left ventricle ejection fraction (LVEF)

  6 month FU

• Increase of left ventricle ejection fraction (LVEF)

  6 month FU

Study Arms (2)

Active Group

EXPERIMENTAL

Patients randomized to the active treatment group will receive 30 000 000 WJMSCs suspended in 20mL 0.9% NaCl and 5% albumin administered via the IRA.

Drug: Cardiac Drug

Control Group

PLACEBO COMPARATOR

Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner.

Drug: Placebos

Interventions

Cardiac Drug DRUG

Patients in the AMI trial will receive one dose of IMP during the index procedure. The IMP administration will be performed by dedicated catheter into infarct related artery. Active IMP consist of 30 000 000 of Wharton's jelly mesenchymal stem cells (WJMSCs) in each IMP dose prepared for patients randomized into active treatment group.

Also known as: CardioCell administration

Active Group

Placebos DRUG

Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner. Control group will receive the same amount of fluid used for WJMSCs preparation, without cells.

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:

• Acute myocardial infarction successfully treated by infarct related artery (IRA) successful revascularization
• Male and female patients, aged 18-80 years
• Large myocardial injury as demonstrated by LVEF ≤45% and/or infarct size (IS) ≥10% of the LV muscle on cMRI 2-5 days after pPCI
• Signed informed consent

You may not qualify if:

• Pacemaker or other contraindications to cardiac MRI
• Malignancy
• Moderate or severe immunodeficiency
• Acute or chronic bacterial or viral infectious disease
• Soft tissue disease or local infection in a place of required artery puncture
• Pregnancy or breastfeeding
• Any objective or subjective reason for inability to attend follow-up visits
• Females of childbearing potential, who does not want to use a highly effective method of contraception
• Females of childbearing potential who does not have a menstrual period confirmed and 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 \< 1 year
• Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project

Sponsors & Collaborators

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

Study Sites (2)

The John Paul II Hospital

Krakow, 31-202, Poland

Location

Central Clinical Hospital of the MSWiA in Warsaw

Warsaw, 02-507, Poland

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Cardiovascular Agents

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

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 AMI trial will enroll 105 patients with randomization into active vs. sham 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 uptake and retention of IMP in the target ischemic tissues.

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 19, 2018
• Study Start: October 20, 2017
• Primary Completion: July 2, 2020
• Study Completion: March 31, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

PL (2)