Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction

NCT01781390 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: ANG.AMI-IC0012010-020497-41
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a double-blind, randomized, placebo-controlled study that was designed to enroll a total of 225 participants with de novo anterior wall acute ST-segment elevation myocardial infarction (STEMI) due to a lesion of the left anterior descending coronary artery undergoing percutaneous coronary intervention (PCI). Eligible participants were to be enrolled and undergo revascularization of the culprit left anterior descending (LAD) coronary artery. The interventional procedure included as dose ranging assessment of intracoronary (IC) delivery of MPC or placebo infused into the stented coronary artery. This study compared two doses of MPCs and a placebo control group. Study participants were randomly assigned in 1:1:1 fashion to receive either 12.5 Million or 25 Million MPCs or placebo (saline). Initially, each group was designed to have approximately 75 patients per treatment group. The Primary Objective of the study was to determine the safety and feasibility of IC infusion of investigational MPCs in this acute STEMI population. The Primary Objective of the study was to determine the safety and feasibility of IC infusion of investigational MPCs in this acute STEMI population. Feasibility of the infusion of the investigational agent was assessed by measurement of thrombolysis in myocardial infarction (TIMI) flow and perfusion (1) immediately prior to, (2) during (after approximately 50% of total investigational agent volume infused) and (3) following the investigational agent infusion after successful PCI and stenting. There was no evidence of clinically important coronary microvascular obstruction related to infusion of the investigational agent.

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial Infarction; STEMI; Heart Attack; AMI; Stem Cells

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Safety measure: An AE is any unfavorable and unintended sign, symptom, or disease, whether or not related to the investigational product. A TEAE was defined as any AE with onset post study drug treatment. An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important.

  Up to approximately 8 years

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received matching-placebo solution 2 milliliters per minute (mL/min) infused Intracoronary for 60 min including line flush \[0 Mesenchymal Precursor Cells (MPCs)/min\] on Day 0.

Other: Placebo

Mesenchymal Precursor Cells (MPC) 12.5 M

EXPERIMENTAL

Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10\^5 MPCs/min) on Day 0.

Biological: Mesenchymal Precursor Cells (MPC) 12.5 M

Mesenchymal Precursor Cells (MPC) 25 M

EXPERIMENTAL

Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10\^5 MPCs/min) on Day 0.

Biological: Mesenchymal Precursor Cells (MPC) 25 M

Interventions

Placebo OTHER

Matching placebo solution for infusion.

Placebo

Mesenchymal Precursor Cells (MPC) 12.5 M BIOLOGICAL

MPC 12.5 M solution for infusion.

Mesenchymal Precursor Cells (MPC) 12.5 M

Mesenchymal Precursor Cells (MPC) 25 M BIOLOGICAL

MPC 25 M solution for infusion.

Mesenchymal Precursor Cells (MPC) 25 M

Eligibility Criteria

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

You may qualify if:

• Clinical symptoms consistent with acute myocardial infarct (AMI) (pain, etc.) for a maximum of 12 hours from onset of symptoms to percutaneous coronary intervention (PCI).
• De Novo anterior AMI.
• Successful revascularization of the culprit lesion.

You may not qualify if:

• Prior AMI, known cardiomyopathy, or hospital admission for heart failure (HF).
• Significant valvular disease.
• Need for other interventional or surgical procedure to treat heart disease (planned or scheduled).
• Cardiogenic shock or hemodynamic instability within 24 hours of randomization.
• Prior PCI to LAD.
• Pacemaker, ICD (Implantable Cardioverter Defibrillator), or any other contra-indication for cardiac MRI.
• Prior or current participation in any stem cell study or any other investigational trial in the past 30 days.

Sponsors & Collaborators

• Mesoblast, Inc.: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Originally, 225 de novo anterior STEMI participants were to undergo primary PCI. However, due to difficulty in consenting participants and operationalizing protocol under emergency conditions associated with acute STEMI, a major protocol amendment was required. The protocol was adjusted to randomize 105 participants. This 53% reduction in participants from the original protocol allowed preliminary evaluations of safety and feasibility.

Results Point of Contact

• Title: Kenneth Borow, MD (Lead, Global Cardiovascular Development)
• Organization: Mesoblast, Inc.

Ken.Borow@Mesoblast.com

(212) 880-2060

Study Officials

• Fred Grossman, DO

  Mesoblast, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: February 1, 2013
• Study Start: March 11, 2013
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: June 23, 2022
• Results First Posted: January 18, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share