Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Rebecca Torguson, Medstar Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Non-ischemic Cardiomyopathy Biological: Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) Other: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
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.
Biological: Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg

Placebo Comparator: Placebo
Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.
Other: Placebo
1.5 mL/kg Lactated Ringer's Solution




Primary Outcome Measures :
  1. Temperature [ Time Frame: up to 12 months post enrollment ]
    Temperature

  2. Uncontrolled systemic infection [ Time Frame: up to 12 months post enrollment ]
    Number of admission for uncontrolled systemic infection

  3. All-cause mortality [ Time Frame: up to 12 months post enrollment ]
    Rate of Death


Secondary Outcome Measures :
  1. NK cell depletion [ Time Frame: Baseline to day 90 ]
    percent reduction in NK cells

  2. 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)

  3. Change in RV systolic function [ Time Frame: Baseline and day 90 post initial infusion ]
    Change in RV systolic function

  4. Hospitalizations due to right heart failure [ Time Frame: day 90 ]
    Number of hospitalizations for to right heart failure

  5. 6 minute walk distance changes [ Time Frame: Baseline and day 90 post initial infusion ]
    6 minute walk distance changes

  6. Gout flares [ Time Frame: Day 90 ]
    Count of gout flares



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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.

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): NCT03925324


Contacts
Layout table for location contacts
Contact: Rebecca Torguson 202-877-5979 rebecca.torguson@medstar.net

Locations
Layout table for location information
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Selma Mohammed, MD, PhD         
Sponsors and Collaborators
Rebecca Torguson

Layout table for additonal information
Responsible Party: Rebecca Torguson, Director, Clinical Research Operations, Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT03925324     History of Changes
Other Study ID Numbers: STEMVAD-001
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiomyopathies
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases