Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device (STEM-VAD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03925324
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Rebecca Torguson, Medstar Health Research Institute

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE May 3, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • Temperature [ Time Frame: up to 12 months post enrollment ]
    Temperature
  • Uncontrolled systemic infection [ Time Frame: up to 12 months post enrollment ]
    Number of admission for uncontrolled systemic infection
  • All-cause mortality [ Time Frame: up to 12 months post enrollment ]
    Rate of Death
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Temperature [ Time Frame: up to 12 months post enrollment ]
    Temperature
  • Uncontrolled systemic infection [ Time Frame: up to 12 months post enrollment ]
    admission for uncontrolled systemic infection
  • All-cause mortality [ Time Frame: up to 12 months post enrollment ]
    All-cause mortality
Change History Complete list of historical versions of study NCT03925324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • NK cell depletion [ Time Frame: Baseline to day 90 ]
    percent reduction in NK cells
  • Change in the following cardiac biomarker [ Time Frame: Baseline and day 90 post initial infusion ]
    The change in the lab values N-Terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP)
  • Change in RV systolic function [ Time Frame: Baseline and day 90 post initial infusion ]
    Change in RV systolic function
  • Hospitalizations due to right heart failure [ Time Frame: day 90 ]
    Number of hospitalizations for to right heart failure
  • 6 minute walk distance changes [ Time Frame: Baseline and day 90 post initial infusion ]
    6 minute walk distance changes
  • Gout flares [ Time Frame: Day 90 ]
    Count of gout flares
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • NK cell depletion [ Time Frame: Baseline to day 90 ]
    defined as % reduction in NK cells
  • Change in the following cardiac biomarker [ Time Frame: Baseline and day 90 post initial infusion ]
    N-Terminal Prohormone of Brain Natriuretic Peptide
  • Change in RV systolic function [ Time Frame: Baseline and day 90 post initial infusion ]
    Change in RV systolic function
  • Hospitalizations due to right HF [ Time Frame: day 90 ]
    Hospitalizations due to right HF
  • 6 minute walk distance changes [ Time Frame: Baseline and day 90 post initial infusion ]
    6 minute walk distance changes
  • Gout flares [ Time Frame: Day 90 ]
    Count of gout flares
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of the Safety and Efficacy of Intravenous Delivery of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients and Implanted Left Ventricular Assist Device
Brief Summary A study to assess the safety and preliminary efficacy of serial intravenous dose of Allogeneic Mesenchymal Bone Marrow Cells in subjects with heart failure and implanted left ventricular assist devices.
Detailed Description A double-blind, placebo-controlled, single-center, randomized study to assess the safety and preliminary efficacy of a three serial intravenous doses of allogeneic mesenchymal bone marrow cells to subjects with heart failure and implanted left ventricular assist devices.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ischemic Heart Disease
  • Non-ischemic Cardiomyopathy
Intervention  ICMJE
  • Biological: Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
    Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg
  • Other: Placebo
    1.5 mL/kg Lactated Ringer's Solution
Study Arms  ICMJE
  • Experimental: Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
    Three intravenous infusions 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 with each infusion 1 month apart.
    Intervention: Biological: Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
  • Placebo Comparator: Placebo
    Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥18 years.
  2. Advanced Heart Failure
  3. Advanced HF defined as HF requiring LVAD implantation and deemed stable on his/her LVAD.
  4. On stable medical therapy (per the discretion of the treating physician) including beta-blockers, ACE-inhibitors, angiotensin receptors blockers, angiotensin receptor neprilysin inhibitor, mineralocorticoid receptor antagonists, isosorbide, hydralazine, and mineralocorticoid receptor antagonists) and optimized pump speed for at least a month prior to randomization.
  5. HS-CRP level≥2 mg/l.
  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. Women of childbearing potential. Postmenopausal women or women with permanent contraception method (defined as total hysterectomy) will not be excluded.
  2. History of debilitating stroke (modified Rankin Score > 3) within 3 months.
  3. The likelihood of requirement of cardiac surgery during the study period.
  4. Presence of clinically significant, uncorrected left sided valvular heart disease, active acute myocarditis, or uncontrolled hypertension defined as Persistently elevated mean arterial blood pressure (>100 mmHg). Echocardiography within 12 months of screening. Patients can be re-evaluated, at the discretion of the investigator.
  5. QTc >550 ms (in the absence of bundle branch block, interventricular conduction delay or ventricular pacing). Electrocardiogram (ECG) within 60 days.
  6. History of cardiac arrest within 3 months.
  7. Hypertrophic or infiltrative cardiomyopathy.
  8. Considered or listed for organ transplantation or history of organ transplantation
  9. Illness other than HF with life expectancy less than 12 months.
  10. Enrolled in an interventional trial or received an experimental drug or device within 30 days of randomization.
  11. Left ventricular assist device implantation >2 years prior to enrollment.
  12. Biventricular assist device (Bi-VAD) support.
  13. Severe COPD defined by FEV1<1L, FEV1/FVC<70% within 12 months if known history of COPD, otherwise FEV1<1L, FEV1/FVC<70% within 24 months
  14. Uncontrolled seizure disorder.
  15. Clinically significant hematologic, hepatic, or renal impairment as determined by screening clinical laboratory tests within the last 30 days:

    Liver disease = ALT or AST > 3x normal, alkaline phosphatase or bilirubin >2x normal Renal disease = on long term dialysis Hematologic = Unexplained persistent leukocytosis (WBC >11 K/UL) or hemoglobin < 8.5 gm/dl

  16. Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the investigator or sponsor may affect compliance with the study protocol or pose a safety risk to the subject.
  17. Inability to comply with the conditions of the protocol.
  18. Acute coronary syndrome within 4 weeks (clinical diagnosis, confirmed by electrocardiographic abnormalities and elevation of troponin-I).
  19. 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.
  20. Active uncontrolled systemic infection. Positive blood or deep tissue cultures or clinical or imaging evidence of systemic infection despite complete course of effective antimicrobial therapy as determined by infectious diseases. Localized (non-systemic) infection is not an exclusion criterion. Patients can be re-evaluated, at the discretion of the investigator.
  21. Early postpartum cardiomyopathy (within six months of diagnosis).
  22. Presence of inherited or acquired immune deficiency or human immunodeficiency virus infection (HIV). Negative HIV test within the preceding 12 months is required.
  23. Systemic corticosteroids, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, tacrolimus, azathioprine, mycophenolate, sirolimus, etc.), and DNA depleting or cytotoxic drugs taken within four weeks prior to study treatment.
  24. Known Porphyria.
  25. Allergy to sodium citrate or any caine type of local anesthetic.
  26. Patient enrolled in hospice care.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Torguson 202-877-5979 rebecca.torguson@medstar.net
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925324
Other Study ID Numbers  ICMJE STEMVAD-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rebecca Torguson, Medstar Health Research Institute
Study Sponsor  ICMJE Rebecca Torguson
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medstar Health Research Institute
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP