A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction (MI-NSTEMI)

Healios

Status and phase: Terminated; Phase 2

Conditions: NSTEMI; Heart Attack

Treatments: Biological: AMI MultiStem cells; Other: Sham

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02277613

1R44HL117572-01A1 (U.S. NIH Grant/Contract)

B02-02

Details and patient eligibility

About

This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).

Enrollment: 34 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects of either gender, 18-85 years of age, inclusive
• Diagnosis of non-ST elevation myocardial infarction (NSTEMI)
• Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45%

Exclusion criteria

• Previous Coronary Artery Bypass Graft (CABG)
• Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
• Previous solid organ transplant
• Anticipated need for additional planned coronary revascularization procedure(s)
• Hemodynamic instability
• Mechanical complications of the index acute myocardial infarction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

AMI MultiStem cells

Experimental group

Description:

AMI MultiStem cells is a cell therapy medicinal product originating from adherent stem cells taken from the bone marrow of a non-related donor and expanded ex vivo.

Treatment:

Biological: AMI MultiStem cells

Sham

Sham Comparator group

Description:

Sham procedure using Micro-Infusion Catheter in coronary artery without injection.

Treatment:

Other: Sham