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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02467387
Recruitment Status : Completed
First Posted : June 10, 2015
Results First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Stemedica Cell Technologies, Inc.
Information provided by (Responsible Party):
CardioCell LLC

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.

Condition or disease Intervention/treatment Phase
Non-Ischemic Heart Failure Drug: Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) Drug: Lactated Ringer's Solution Phase 2

Detailed Description:
A phase IIa, single-blind, placebo-controlled, crossover, multi-center, randomized study to assess the safety, tolerability, and preliminary efficacy of a single intravenous dose of ischemia-tolerant allogeneic mesenchymal bone marrow cells to subjects with heart failure of non-ischemic etiology.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase IIa Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Non-ischemic Heart Failure
Actual Study Start Date : June 1, 2014
Actual Primary Completion Date : May 11, 2017
Actual Study Completion Date : May 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Experimental: Human (aMBMC)
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)
One time infusion Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg.
Other Name: Mesenchymal Stem Cells, (MSC) Marrow Stromal Cells.

Placebo Comparator: Placebo:Lactated Ringer's Solution (LRS)
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
One time infusion 1.5mL/kg
Other Name: (LRS)

Primary Outcome Measures :
  1. Safety Will be Evaluated by Number of AE [ Time Frame: Total AEs and SAEs within 450 days post-infusion ]
    As identified in the SAP, the safety analysis was the primary objective and was evaluated by the number of AEs

Secondary Outcome Measures :
  1. Change in LVEF From Baseline to Day 90 Post-initial Infusion. [ Time Frame: Baseline to Day 90 ]
    The secondary efficacy endpoint was the change in LVEF from baseline to Day 90 post-initial infusion. Participants with data available at each time point.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males and females ≥18 years of age
  2. LVEF ≤35% on echocardiogram within 12 months of randomization to undergo MRI
  3. 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

  4. 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
  5. Patients with history of heart failure and treated for at least three months with GDMT
  6. NYHA class II-III symptoms
  7. Ability to understand and provide signed informed consent
  8. Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits

Exclusion Criteria:

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

    • Liver disease = ALT or AST > 3x normal, alkaline phosphatase or bilirubin >2x normal)
    • Renal disease = estimated glomerular filtration rate as assessed by the MDRD formula <30 ml/min
    • Hematologic = Unexplained leukocytosis >10 or hemoglobin < 9gm/dl
  16. Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the investigator or sponsor for which participation in the study would pose a safety risk to the subject
  17. Inability to comply with the conditions of the protocol
  18. Malignancy within the previous five years, except adequately treated basal cell carcinoma, provided that it is neither infiltrating nor sclerosing, and carcinoma in situ of the cervix
  19. Active myocarditis or early postpartum cardiomyopathy (within six months).
  20. Systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), and DNA depleting or cytotoxic drugs taken within four weeks prior to study treatment
  21. Porphyria
  22. Allergy to sodium citrate or any "caine" type of local anesthetic
  23. Any contraindication for gadolinium use for MRI
  24. Patient scheduled for hospice care
  25. Clinically relevant abnormal findings in the clinical history, physical examination, ECG, or laboratory tests at the screening assessment that would interfere with the objectives of the study or would preclude safe completion of the study. Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection (such as hepatitis B or C), acute systemic infections (defined as patients undergoing treatment with antibiotics), gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury
  26. Any other medical, social, or geographical factor that would make it unlikely that the patient could comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or noncompliance)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467387

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United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Centers for Heart Failure Therapy
Chicago, Illinois, United States, 60611
United States, New York
Stony Brook Heart Institute
Stony Brook, New York, United States, 11794
United States, Pennsylvania
Hospital of the University of Pennsylvania, Heart Failure and Transplant Program
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
CardioCell LLC
Stemedica Cell Technologies, Inc.
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Study Director: Kristrun Stardal, RN, BSN Clinical Operations Manager
  Study Documents (Full-Text)

Documents provided by CardioCell LLC:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CardioCell LLC
ClinicalTrials.gov Identifier: NCT02467387    
Obsolete Identifiers: NCT02123706
Other Study ID Numbers: STEM-104-M-CHF
First Posted: June 10, 2015    Key Record Dates
Results First Posted: January 7, 2020
Last Update Posted: January 7, 2020
Last Verified: December 2019
Keywords provided by CardioCell LLC:
Non-ischemic Heart Failure
Stem Cells
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases