Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device

NCT03925324 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: STEMVAD-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Non-ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• Temperature

  Temperature

  up to 12 months post enrollment

• Uncontrolled Systemic Infection

  Number of admission for uncontrolled systemic infection

  up to 12 months post enrollment

• All-cause Mortality

  Rate of Death

  up to 12 months post enrollment

Secondary Outcomes (6)

• NK Cell Depletion

  Baseline to day 90

• Change in the Following Cardiac Biomarker

  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

  day 90

• 6 Minute Walk Distance Changes

  Baseline and day 90 post initial infusion

Study Arms (2)

Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) BIOLOGICAL

Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg

Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)

Placebo OTHER

1.5 mL/kg Lactated Ringer's Solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Limitations and Caveats

Due to lack of funding and COVID-19, the study was terminated early after 4 patients were recruited. This number is too small to perform any analysis

Results Point of Contact

• Title: Megan Rowland
• Organization: Medstar Health Research Institute

megan.e.rowland@medstar.net

202-877-2959

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 24, 2019
• Study Start: May 3, 2019
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: February 2, 2022
• Results First Posted: February 2, 2022

Record last verified: 2022-01

Locations

US (1)