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Growth Factor

Human FGF-1 for Peripheral Arterial Disease

Phase 1 & 2
Waitlist Available
Research Sponsored by CardioVascular BioTherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment through study completion, an average of 12 weeks
Awards & highlights

Study Summary

This trial tests a new treatment, FGF-1, for peripheral arterial disease with intermittent claudication.

Eligible Conditions
  • Peripheral Arterial Disease
  • Intermittent Claudication
  • Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment through study completion, an average of 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment through study completion, an average of 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in safety laboratory measurements at 12 weeks
Number of participants with adverse events as a measure of safety and tolerability of i.m. injected Cardio Vascu Grow TM, a recombinant Human Fibroblast Growth Factor-1 (FGF-1-141)
Secondary outcome measures
Plasma FGF-1 (1-141) pharmacokinetic measurements at pre-dose, 5, 15, and 30 minutes and at 1, 2, 4, 6, 10, and 24 hours

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Human FGF-1Active Control1 Intervention
The dosing groups correspond to total doses of either 3, 10 or 30 µg/kg of FGF-1.
Group II: PlaceboPlacebo Group1 Intervention
The dosing groups correspond to total doses of 0 µg/kg of FGF-1.

Find a Location

Who is running the clinical trial?

CardioVascular BioTherapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
158 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease
2020. "FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00424866.
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~6 spots leftby Apr 2025
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