Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC)

NCT02293603 | Unknown Phase 1 DMC

• 2 other identifiers: CAP-1002 (DYNAMIC)R44HL095203
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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-1002.

Conditions

Dilated Cardiomyopathy (DCM); Ischemic Cardiomyopathy; Nonischemic Cardiomyopathy; Heart Failure

Keywords

cardiomyopathy; cardiosphere-derived stem cells; intracoronary infusion; adult stem cells; heart disease; ventricular dysfunction; pathological processes; cardiovascular diseases; heart failure

Outcome Measures

Primary Outcomes (5)

• Proportion of subjects that experience new TIMI flow 0-2 or TIMI myocardial perfusion grade (TMPG) 0-2.

  Intraprocedural

• Proportion of subjects that experience acute myocarditis, possibly attributable to CAP-1002. In order to be considered related to CAP-1002, humoral or cellular or immune reaction specific to CAP-1002 must also be documented.

  Within one month of intracoronary infusion

• Proportion of subjects that experience ventricular tachycardia or ventricular fibrillation resulting in death, appropriate discharge of an ICD or requiring medical intervention.

  During or within 72 hours of intracoronary infusion

• Proportion of subjects that experience sudden unexpected death occurring within one hour of symptom onset, or un-witnessed death in a person previously observed to be well within the preceding 24 hours without an identified cause.

  During or within 72 hours of intracoronary infusion

• Proportion of subjects that experience major adverse cardiac events (MACE), including death, non-fatal myocardial infarction and re-hospitalization for cardiovascular event (including heart failure hospitalizations).

  During or within 72 hours of intracoronary infusion

Secondary Outcomes (10)

• Acute myocarditis possibly attributable to CAP-1002. In order to be considered related to CAP-1002, humoral or cellular immune reaction specific to CAP-1002 must also be documented.

  During the six & twelve month follow-up period

• Ventricular tachycardia or ventricular fibrillation resulting in death or requiring medical intervention or appropriate discharge of an ICD.

  During the six & twelve month follow-up period

• Sudden unexpected death defined as occurring within one hour of symptom onset, or unwitnessed death in a person previously observed to be well within the preceding 24 hours without an identified cause.

  During the six & twelve month follow-up period

• Major adverse cardiac events (MACE), including death, non-fatal myocardial infarction, hospitalization for cardiovascular event, emergency room treatment for heart failure, left ventricular assist device or heart transplant.

  During the six & twelve month follow-up period

• Any hospitalization due to a cardiovascular cause or related to CAP-1002 (or placebo in Phase Ib).

  During the six & twelve month follow-up period

Study Arms (2)

Allogeneic Cardiosphere-Derived Cells

EXPERIMENTAL

The Phase I study consists of a Phase Ia portion and a Phase Ib portion. The Phase Ia portion (N=14 subjects) consists of an open-label, single-arm, study design. The potentially conducted Phase Ib portion of the study (N=28 subjects) consists of a double-blind, randomized, placebo-controlled study design. The Phase Ia portion is an open-label, dose escalation of Allogeneic Cardiosphere-Derived Cells (CDCs).

Biological: Allogeneic Cardiosphere-Derived Cells (CDCs)

Placebo

PLACEBO COMPARATOR

The placebo study arm only applies to the Phase Ib portion of the study design. The Phase Ia portion (N=14 subjects) consists of an open-label, single-arm, study design. The potentially conducted Phase Ib portion of the study (N=28 subjects) consists of a double-blind, randomized, placebo-controlled study design.

Biological: Allogeneic Cardiosphere-Derived Cells (CDCs)

Interventions

Allogeneic Cardiosphere-Derived Cells (CDCs) BIOLOGICAL

Intracoronary delivery of CAP-1002 or placebo

Also known as: CAP-1002

Allogeneic Cardiosphere-Derived Cells; Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capricor Inc.: lead
• Cedars-Sinai Medical Center: collaborator
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Links

• Capricor's website

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Heart Failure; Cardiomyopathies; Heart Diseases; Ventricular Dysfunction; Pathologic Processes; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms

Study Officials

• Rajendra (Raj) Makkar, MD

  Cedars-Sinai Medical Center, Heart Institute

  PRINCIPAL INVESTIGATOR

• Deborah Ascheim, MD

  Capricor Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 18, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: April 1, 2020
• Last Updated: June 21, 2016

Record last verified: 2016-06

Locations

US (1)