- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925324
Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device (STEM-VAD)
January 3, 2022 updated by: Medstar Health Research Institute
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
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.
Study Overview
Status
Terminated
Intervention / Treatment
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
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- MedStar Washington Hospital Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥18 years.
- Advanced Heart Failure
- Advanced HF defined as HF requiring LVAD implantation and deemed stable on his/her LVAD.
- 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.
- HS-CRP level≥2 mg/l.
- 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
Exclusion Criteria:
- Women of childbearing potential. Postmenopausal women or women with permanent contraception method (defined as total hysterectomy) will not be excluded.
- History of debilitating stroke (modified Rankin Score > 3) within 3 months.
- The likelihood of requirement of cardiac surgery during the study period.
- 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.
- QTc >550 ms (in the absence of bundle branch block, interventricular conduction delay or ventricular pacing). Electrocardiogram (ECG) within 60 days.
- History of cardiac arrest within 3 months.
- Hypertrophic or infiltrative cardiomyopathy.
- Considered or listed for organ transplantation or history of organ transplantation
- Illness other than HF with life expectancy less than 12 months.
- Enrolled in an interventional trial or received an experimental drug or device within 30 days of randomization.
- Left ventricular assist device implantation >2 years prior to enrollment.
- Biventricular assist device (Bi-VAD) support.
- 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
- Uncontrolled seizure disorder.
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
- 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.
- Inability to comply with the conditions of the protocol.
- Acute coronary syndrome within 4 weeks (clinical diagnosis, confirmed by electrocardiographic abnormalities and elevation of troponin-I).
- 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.
- 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.
- Early postpartum cardiomyopathy (within six months of diagnosis).
- Presence of inherited or acquired immune deficiency or human immunodeficiency virus infection (HIV). Negative HIV test within the preceding 12 months is required.
- 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.
- Known Porphyria.
- Allergy to sodium citrate or any caine type of local anesthetic.
- Patient enrolled in hospice care.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
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.
|
1.5 mL/kg Lactated Ringer's Solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temperature
Time Frame: up to 12 months post enrollment
|
Temperature
|
up to 12 months post enrollment
|
Uncontrolled Systemic Infection
Time Frame: up to 12 months post enrollment
|
Number of admission for uncontrolled systemic infection
|
up to 12 months post enrollment
|
All-cause Mortality
Time Frame: up to 12 months post enrollment
|
Rate of Death
|
up to 12 months post enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NK Cell Depletion
Time Frame: Baseline to day 90
|
percent reduction in NK cells
|
Baseline to day 90
|
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)
|
Baseline and day 90 post initial infusion
|
Change in RV Systolic Function
Time Frame: Baseline and day 90 post initial infusion
|
Change in RV systolic function
|
Baseline and day 90 post initial infusion
|
Hospitalizations Due to Right Heart Failure
Time Frame: day 90
|
Number of hospitalizations for to right heart failure
|
day 90
|
6 Minute Walk Distance Changes
Time Frame: Baseline and day 90 post initial infusion
|
6 minute walk distance changes
|
Baseline and day 90 post initial infusion
|
Gout Flares
Time Frame: Day 90
|
Count of gout flares
|
Day 90
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 3, 2019
Primary Completion (Actual)
August 16, 2021
Study Completion (Actual)
August 16, 2021
Study Registration Dates
First Submitted
April 1, 2019
First Submitted That Met QC Criteria
April 19, 2019
First Posted (Actual)
April 24, 2019
Study Record Updates
Last Update Posted (Actual)
February 2, 2022
Last Update Submitted That Met QC Criteria
January 3, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STEMVAD-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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