Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Ischemic Left Ventricular Dysfunction Myocardial Infarction

Keywords

CardiovascularSecondary

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
+17 more secondary outcomes

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 hMSCsDevice: 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 IIDevice: Biosense Webster MyoStar NOGA Injection Catheter System

Interventions

Autologous hMSCsDrug

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 IIDrug

Eligibility Criteria

Age21 Years - 89 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Joshua M Hare
Otherlead

Study Sites (1)

ISCI / University of Miami

Miami, Florida, 33136, United States

MeSH Terms

Conditions

Myocardial InfarctionNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisNeoplastic ProcessesNeoplasms

Study Officials

Joshua M Hare, MD
ISCI / University of Miami Miller School of Medicine
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (22)

Study Arms (3)

Group A - Autologous hMSCs

Group B - Autologous Human C-Kit CSCs II

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (22)

Study Arms (3)

Group A - Autologous hMSCs

Group B - Autologous Human C-Kit CSCs II

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations