Status:
UNKNOWN
Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC)
Lead Sponsor:
Capricor Inc.
Collaborating Sponsors:
Cedars-Sinai Medical Center
National Institutes of Health (NIH)
Conditions:
Dilated Cardiomyopathy (DCM)
Ischemic Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the safety profile of CAP-1002 administered by multi-vessel intracoronary infusion in subjects with DCM. The study will further explore safety and exploratory efficacy endpoints of CAP-10...
Detailed Description
Eligible subjects will undergo sequential intracoronary infusion of CAP-1002 or placebo in up to three coronary arteries supplying three major cardiac territories to the heart (anterior, lateral, infe...
Eligibility Criteria
Inclusion
- Major
- DCM with left ventricular ejection fraction (LVEF) ≤ 35% as determined by a historical TTE within the previous 6 months
- New York Heart Association (NYHA) Class III or ambulatory Class IV heart failure
- Use of evidence based medical-therapy (beta-blockers, ACE-inhibitors/angiotensin receptor blockers, aldosterone antagonist) and with or without device-therapy (Implantable cardioverter-defibrillator or cardiac resynchronizing therapy), in accordance with the ACC/AHA guidelines for the management of heart failure, for at least three months prior to enrollment or documented contraindication or intolerance or patient preference
- Coronary anatomy suitable for Investigational Product (IP) infusion, as determined by the Eligibility Committee (a team of cardiology experts)
- Ability to provide informed consent and follow-up with protocol procedures
- Screening cardiac CT left ventriculogram ejection fraction \<40% with left ventricular dilatation
- Age ≥ 18 years
- Major
Exclusion
- Diagnosis of active myocarditis
- Immunologic incompatibility with all available Master Cell Banks (MCBs) by single-antigen bead (SAB) serum antibody profiling
- Left Ventricular Assist Devices (LVAD) or those actively in the process of acquiring one
- Recent placement of a cardiac pacemaker and/or resynchronization pacing therapy within the past three months or those actively in the process of acquiring one
- History of sustained ventricular tachycardia (VT) requiring cardiopulmonary resuscitation (with the exception of subjects who subsequently received an ICD)
- Non-cardiovascular disease with life expectancy of \< 3 years
- Known hypersensitivity to contrast agents
- Estimated glomerular filtration rate (GFR) \< 50 mL/min
- Active infection not responsive to treatment
- Active allergic reactions, connective tissue disease or autoimmune disorders
- History of cardiac tumor, or cardiac tumor demonstrated on screening
- History of previous stem cell therapy
- History of treatment with immunosuppressive agents, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs or anti-vascular endothelial growth factor (VEGF) within 6 months prior to enrollment (not including drug eluting coronary stents)
- History of receipt of chemotherapeutic agents known to be implicated in cardiac dysfunction \[Adriamycin, trastuzumab (Herceptin)\]
- Known moderate-severe aortic stenosis/insufficiency or severe mitral stenosis/regurgitation
- Participation in an on-going protocol studying an experimental drug or device
- Current active alcohol or drug abuse or inability to comply with protocol-related procedures
- Pregnant/nursing women and women of child-bearing potential without use of active and highly reliable contraception
- Known history of Human Immunodeficiency Virus (HIV) infection
- Known history of chronic viral hepatitis
- Abnormal liver function (serum glutamic pyruvic transaminase (SGPT) \> 10 times the upper reference range) and/or abnormal hematology (hematocrit \< 25%, white blood cells (WBC) \< 3000 µl, platelets \< 100,000 µl) studies without a reversible, identifiable cause
- Evidence of tumor on screening of chest/abdominal/pelvic (body) CT scan
- Any prior organ transplant
- Being actively listed for, or under active consideration (i.e., work-up) for, a solid organ transplant of any kind
- Known hypersensitivity to bovine products
- Known hypersensitivity to dimethyl sulfoxide (DMSO)
- Any malignancy within past 2 years (except for in-situ non-melanoma skin cancer and in-situ cervical cancer)
- Any prior radiation therapy/treatment to the chest
- Uncontrolled diabetes (HbA1 \>9.0)
- Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the study
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02293603
Start Date
November 1 2014
End Date
April 1 2020
Last Update
June 21 2016
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048