The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial.

NCT02503280 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 20120203
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested. The randomized portion of the study will be conducted after a full review of the safety data from the pilot Phase by the Data safety monitoring board. Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline. Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.

Conditions

Chronic Ischemic Left Ventricular Dysfunction; Myocardial Infarction

Keywords

Cardiovascular; Secondary

Outcome Measures

Primary Outcomes (1)

• Incidence of any treatment emergent serious adverse events (TE-SAEs)

  Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or atrial fibrillation.

  One Month post-catheterization

Secondary Outcomes (22)

• Treatment Emergent adverse event rates

  At 6 Month and 12 Month visit

• Ectopic tissue formation

  At 6 Month and 12 Month visit

• 48-hour ambulatory electrocardiogram (ECG) recordings.

  At 6 Month and 12 Month visit

• Hematology value changes post-catheterization

  At 6 Month and 12 Month visit

• Urinalysis results changes post-catheterization

  At 6 Month and 12 Month visit

Study Arms (3)

Group A - Autologous hMSCs

EXPERIMENTAL

Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10\^8 (200 million) hMSCs. The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug.

Drug: Autologous hMSCs; Device: Biosense Webster MyoStar NOGA Injection Catheter System

Group B - Autologous Human C-Kit CSCs II

EXPERIMENTAL

Autologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10\^8 (199 million) hMSCs and 1 million C-Kit hCSCs.The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug.

Drug: Autologous Human C-Kit CSCs II; Device: Biosense Webster MyoStar NOGA Injection Catheter System

Placebo

PLACEBO COMPARATOR

Placebo (ten 0.5 ml injections of phosphate-buffered saline \[PBS\] and 1% human serum albumin \[HSA\]).The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug.

Drug: Placebo; Device: Biosense Webster MyoStar NOGA Injection Catheter System

Interventions

Autologous hMSCs DRUG

Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10\^8 (200 million) hMSCs.

Also known as: Autologous Human Mesenchymal Stem Cells (hMSCs)

Group A - Autologous hMSCs

Autologous Human C-Kit CSCs II DRUG

Autologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10\^8 (199 million) hMSCs and 1 million C-Kit hCSCs.

Also known as: Autologous Human C-Kit Cardiac Stem Cells (CSCs) II

Group B - Autologous Human C-Kit CSCs II

Placebo DRUG

Placebo (ten 0.5 ml injections of phosphate-buffered saline \[PBS\] and 1% human serum albumin \[HSA\]).

Placebo

Biosense Webster MyoStar NOGA Injection Catheter System DEVICE

Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug

Also known as: NOGA

Group A - Autologous hMSCs; Group B - Autologous Human C-Kit CSCs II; Placebo

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to participate in this study, a patient MUST:
• Be ≥ 21 and \< 90 years of age.
• Provide written informed consent.
• Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by the following: Screening MRI must show an area of akinesis, dyskinesis, or severe hypokinesis associated with evidence of myocardial scarring based on delayed hyperenhancement following gadolinium infusion.
• Been treated with appropriate maximal medical therapy for heart failure or post-infarction left ventricular dysfunction. For beta-blockade, the patient must have been on a stable dose of a clinically appropriate beta-blocker for 3 months. For angiotensin-converting enzyme inhibition, the patient must have been on a stable dose of a clinically appropriate agent for 1 month.
• Be a candidate for cardiac catheterization.
• Have an ejection fraction ≤ 50% by gated blood pool scan, two-dimensional echocardiogram, cardiac MRI, or left ventriculogram within the prior six months and not in the setting of a recent ischemic event.

You may not qualify if:

• In order to participate in this study, a patient MUST NOT:
• Have a baseline glomerular filtration rate \< 50 ml/min1.73m2.
• Have a known, serious radiographic contrast allergy.
• Have a mechanical aortic valve or heart constrictive device.
• Have a documented presence of aortic stenosis (aortic stenosis graded as ≥ +2 equivalent to an orifice area of 1.5cm2 or less).
• Have a documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
• Require coronary artery revascularization. Patients who require or undergo revascularization procedures should undergo these procedures a minimum of 3 months in advance of treatment within this study. In addition, patients who develop a need for revascularization following enrollment will be submitted for this therapy without delay.
• Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete heart block) or QTc interval \> 550 ms on screening ECG.
• AICD firing in the past 60 days prior to the procedure.
• Have unstable angina within 2 weeks of the planned procedure.
• Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet values \< 100,000/ul without another explanation.
• Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
• Have a coagulopathy = (INR \> 1.3) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn 5 days before the procedure and confirmed to have an INR \< 1.3. Patients who cannot be withdrawn from Coumadin will be excluded from enrollment
• Have known allergies to penicillin or streptomycin.
• Have a contra-indication to performance of an MRI scan.

Sponsors & Collaborators

• Joshua M Hare: lead

Study Sites (1)

ISCI / University of Miami

Miami, Florida, 33136, United States

Location

Related Links

• Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine

MeSH Terms

Conditions

Myocardial Infarction; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Neoplastic Processes; Neoplasms

Study Officials

• Joshua M Hare, MD

  ISCI / University of Miami Miller School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ISCI Director, Chief Science Officer, Senior Assoc. Dean, Louis Lemberg Professor of Medicine

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: July 20, 2015
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2032
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

US (1)