A Study to Assess the Effect of Intravenous Dose of (aMBMC) to Subjects With Non-ischemic Heart Failure

NCT02467387 | Completed Phase 2 Results DMC

• 1 other identifier: STEM-104-M-CHF
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 5

Brief Summary

A phase IIa study to assess the safety and preliminary efficacy of intravenous dose of ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells in subjects with non-ischemic heart failure.

Conditions

Non-Ischemic Heart Failure

Keywords

Non-ischemic Heart Failure; Stem Cells

Outcome Measures

Primary Outcomes (1)

• Safety Will be Evaluated by Number of AE

  As identified in the SAP, the safety analysis was the primary objective and was evaluated by the number of AEs

  Total AEs and SAEs within 450 days post-infusion

Secondary Outcomes (1)

• Change in LVEF From Baseline to Day 90 Post-initial Infusion.

  Baseline to Day 90

Study Arms (2)

Experimental: Human (aMBMC)

EXPERIMENTAL

Intervention: One time intravenous infusion of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more.

Drug: Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)

Placebo:Lactated Ringer's Solution (LRS)

PLACEBO COMPARATOR

Intervention: One time intravenous infusion of 1.5mL/kg Lactated Ringer's Solution (LRS) administered at a constant rate of approximately 2mL/min.

Drug: Lactated Ringer's Solution

Interventions

Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) DRUG

One time infusion Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg.

Also known as: Mesenchymal Stem Cells, (MSC) Marrow Stromal Cells.

Experimental: Human (aMBMC)

Lactated Ringer's Solution DRUG

One time infusion 1.5mL/kg

Also known as: (LRS)

Placebo:Lactated Ringer's Solution (LRS)

Eligibility Criteria

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

You may qualify if:

• Males and females ≥18 years of age
• LVEF ≤35% on echocardiogram within 12 months of randomization to undergo MRI
• Screening cardiac MRI at baseline with:
• Ejection fraction ≤40% No significant hyper enhancement on MRI scan in the opinion of the central imaging lab reviewer
• Patients with non-ischemic heart failure etiology, as documented by absent or non-obstructive coronary artery disease on x-ray angiography or coronary computed tomography
• Patients with history of heart failure and treated for at least three months with GDMT
• NYHA class II-III symptoms
• Ability to understand and provide signed informed consent
• Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits

You may not qualify if:

• Pregnant or nursing women or those of childbearing age and not using an effective method of contraception
• History of stroke within 3 months
• Cardiac surgery within 3 months prior to randomization or the likelihood of a requirement for such procedures during the study period
• Current ICD or CRT or implantation planned within 6 months of infusion
• Presence of clinically significant, uncorrected valvular heart disease, hypertrophic or restrictive cardiomyopathy, active myocarditis, or uncontrolled hypertension
• History of cardiac arrest or life-threatening arrhythmias within 3 months
• Treatment with parenteral inotropic agents within 1 month of randomization
• Anticipated cardiac transplantation within 1 year
• Illness other than heart failure with life expectancy less than 1 year
• Received an experimental drug or device within 30 days of randomization
• Left ventricular assist device or implantation planned in the next 6 months
• Patients with complex congenital heart disease
• Uncontrolled seizure disorder
• Presence of immune deficiency
• Clinically significant hematologic, hepatic, or renal impairment as determined by screening clinical laboratory tests:

Sponsors & Collaborators

• CardioCell LLC: lead
• Stemedica Cell Technologies, Inc.: collaborator

Study Sites (5)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University Centers for Heart Failure Therapy

Chicago, Illinois, 60611, United States

Location

Stony Brook Heart Institute

Stony Brook, New York, 11794, United States

Location

Hospital of the University of Pennsylvania, Heart Failure and Transplant Program

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Butler J, Epstein SE, Greene SJ, Quyyumi AA, Sikora S, Kim RJ, Anderson AS, Wilcox JE, Tankovich NI, Lipinski MJ, Ko YA, Margulies KB, Cole RT, Skopicki HA, Gheorghiade M. Intravenous Allogeneic Mesenchymal Stem Cells for Nonischemic Cardiomyopathy: Safety and Efficacy Results of a Phase II-A Randomized Trial. Circ Res. 2017 Jan 20;120(2):332-340. doi: 10.1161/CIRCRESAHA.116.309717. Epub 2016 Nov 16.

  PMID: 27856497 DERIVED

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Sergey Sikora, President and CEO
• Organization: CardioCell, LLC

SSIKORA@STEMCARDIOCELL.COM

760-315-0861

Study Officials

• Kristrun Stardal, RN, BSN

  Clinical Operations Manager

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 10, 2015
• Study Start: June 1, 2014
• Primary Completion: May 11, 2017
• Study Completion: May 11, 2017
• Last Updated: January 7, 2020
• Results First Posted: January 7, 2020

Record last verified: 2019-12

Locations

US (5)