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Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease

NCT00117936 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-11-01

No results posted yet for this study

Summary

Treatment for no-option heart patients with coronary artery disease. Procedure includes the injection into the heart of a protein growth factor, administered by the Biological Delivery Systems MyoStar injection and mapping catheters, to stimulate the growth of blood vessels around blocked coronary arteries.

Conditions

Interventions

COMBINATION_PRODUCT

Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose

Up to ten intramyocardial injections of low dose FGF 1-141, via a NOGA Injection Catheter, single cath lab session

COMBINATION_PRODUCT

Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose

Up to ten intramyocardial injections of high dose group (FGF-1-141), via a NOGA Injection Catheter, single cath lab session

COMBINATION_PRODUCT

Placebo

Up to ten intramyocardial injections of placebo via a NOGA Injection Catheter, single cath lab session

Sponsors & Collaborators

  • CardioVascular BioTherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Emerson Perin, MD, PhD · Texas Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2022-03-31
Completion
2023-03-31
FDA Drug
Yes
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00117936 on ClinicalTrials.gov