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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stemedica Cell Technologies, Inc.
Information provided by (Responsible Party):
CardioCell LLC
ClinicalTrials.gov Identifier:
NCT02467387
First received: June 2, 2015
Last updated: April 19, 2016
Last verified: April 2016
  Purpose
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 Intervention Phase
Non-Ischemic Heart Failure
Drug: Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
Drug: Lactated Ringer's Solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by CardioCell LLC:

Primary Outcome Measures:
  • Safety will be evaluated by the incidence, severity, and relationship of AEs and SAEs [ Time Frame: Change from Baseline, days 30, 60, 90, days 270 and 450 post initial infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in LVEF from baseline to day 90 post-initial infusion. After crossover phase all subjects will be evaluated for changes from the new baseline (Day 90 after initial infusion) to Day 90 post second infusion. [ Time Frame: Baseline to Day 90 ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: June 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02467387

Locations
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
Philedelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
CardioCell LLC
Stemedica Cell Technologies, Inc.
Investigators
Study Director: Kristrun Stardal, RN, BSN Clinical Operations Manager
  More Information

Responsible Party: CardioCell LLC
ClinicalTrials.gov Identifier: NCT02467387     History of Changes
Obsolete Identifiers: NCT02123706
Other Study ID Numbers: STEM-104-M-CHF 
Study First Received: June 2, 2015
Last Updated: April 19, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by CardioCell LLC:
Non-ischemic Heart Failure
Stem Cells

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on September 23, 2016