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FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00424866
Recruitment Status : Not yet recruiting
First Posted : January 22, 2007
Last Update Posted : November 1, 2019
Information provided by (Responsible Party):
CardioVascular BioTherapeutics, Inc.

Brief Summary:
FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Stenosis Intermittent Claudication Drug: FGF-1 Drug: Placebo Phase 1 Phase 2

Detailed Description:
FGF-1 administered by intramuscular injection for the treatment of peripheral arterial disease with intermittent claudication. Eligible patients are allocated to one of three treatment arms. Patients within each dosing group will be randomized between study drug and vehicle control. Safety, pharmacokinetics, and cardiovascular improvement will be evaluated at day 1 and weeks 1, 4 and 12 post dosing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Peripheral Arterial Disease Patients With Intermittent Claudication
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
The dosing groups correspond to total doses of 0 µg/kg of FGF-1.
Drug: Placebo
Vehicle: 0 µg/kg

Active Comparator: Human FGF-1
The dosing groups correspond to total doses of either 3, 10 or 30 µg/kg of FGF-1.
Drug: FGF-1

Doses of FGF-1: 3 ug/kg; 10 ug/kg; 30 ug/kg

Low dose: 3.0 μg/kg Mid dose: 10 μg/kg High dose: 30 µg/kg

Other Name: Acidic FGF

Primary Outcome Measures :
  1. 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) [ Time Frame: From enrollment through study completion, an average of 12 weeks ]
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)

  2. Change from baseline in safety laboratory measurements at 12 weeks [ Time Frame: From enrollment through study completion, an average of 12 weeks ]
    Safety laboratory evaluations on hematology, serum chemistry, and urinalysis

Secondary Outcome Measures :
  1. 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 [ Time Frame: From enrollment through study completion, an average of 12 weeks ]
    Pharmacokinetic plasma concentrations of FGF-1 (1-141)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.
  2. Age must be ≥50 and ≤75 years of age with a life expectancy of > 1 year and leg survival > 6 months. Patients >75 and ≤80 years of age will be considered if they show no signs of cognitive or muscle function decline and are fully able to comply with the protocol.
  3. Patients must have experienced intermittent claudication for at least 6 months and have been stable for the past 3 months.
  4. Patients must have peripheral arterial disease, as confirmed by a resting ABI ≥0.40 and <0.90 based on at least one leg as measured using both the dorsal pedis and posterior tibial arteries.
  5. Stenosis of >70% up to total occlusion must be present in the popliteal artery and/or in the tibial peroneal trunk or at least 2 tibial arteries above the ankle without inflow limitation of the popliteal artery. Adequate popliteal inflow is defined as continuous flow from the abdominal aorta, iliac, common femoral and superficial femoral with any stenosis < 50% as determined either by intra-arterial DSA, CTA or Gd CE-MRA.
  6. The screening Gardner treadmill test peak walking times (PWT) must be >1 minute and < 12 minutes and limited by pain in one or both calves.
  7. Preexisting medication regime must be stable for 6 weeks preceding dosing.

Exclusion Criteria

  1. Evidence of critical leg ischemia, i.e. ischemic rest pain or ischemic ulceration
  2. Treadmill walking limited by conditions other than intermittent claudication including arthritis, angina and dyspnea
  3. Lower limb amputation of, or in, either leg including toes
  4. Evidence of limb ischemia from immunologic or inflammatory disorders
  5. Leg surgery or revascularization within past 6 months or peripheral angioplasty within past 3 months or anticipated during study
  6. Participation in any investigational device or drug trial within the past 6 months
  7. Myocardial infarction, unstable angina, stroke or ischemic attack within past 6 months
  8. New York Heart Association (NYHA) class II, III or IV heart failure, restrictive or hypertrophic cardiomyopathy or severe valvular disease
  9. QTc elongation greater than 450 ms in males or 460 ms in females
  10. PT (INR), PTT, urinalysis, thyroid function (T3, T4, TSH) outside normal limits
  11. Hemorrhage or thrombotic events (e.g. deep vein thrombosis) within past 6 months
  12. Thrombocytopenia (<100,000/µl), history of heparin-induced thrombocytopenia
  13. Major surgery with the past 6 months
  14. Positive proliferative retinopathy exam
  15. Present of any type of cancer or history of cancer except past (but not present) basal cell dermal carcinoma not on either leg
  16. Inflammatory or progressive fibrotic or myelofibrotic disorders
  17. Patients experiencing bacterial or viral infection (e.g. hepatitis or HIV) or who may otherwise be febrile
  18. Hemoglobin A1c(HgbA1c) of >8%
  19. Type I diabetes
  20. Total fasting cholesterol >200
  21. Uncontrolled hypertension (≥160 systolic or ≥100 diastolic pressure) or hypotension (<90 systolic or <60 diastolic pressure)
  22. Disease or drug (e.g. systemic corticosteroid) immuno-compromised
  23. Hepatic dysfunction as defined either by AST or ALT > 2.0 times the upper limit of normal
  24. Serum creatinine of ≥ 2.5 mg/dl
  25. Proteinuria (urine protein/creatinine ratio > 3)
  26. Antiproliferative drugs (e.g. thalidomide, hydroxyurea)
  27. Radiation therapy
  28. Implanted devices not compatible with strong magnetic fields
  29. Life expectance of less than 1 year
  30. Females who are premenopausal and not sterilized or using adequate birth control or are either pregnant, intend to become pregnant or are nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00424866

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Contact: Warren Sherman, MD (972) 681-9368
Contact: Adam Nedella (972) 681-9368

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United States, Texas
Dallas, Texas, United States, 75238
Sponsors and Collaborators
CardioVascular BioTherapeutics, Inc.

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Responsible Party: CardioVascular BioTherapeutics, Inc. Identifier: NCT00424866    
Other Study ID Numbers: CVBT-2006-PAD-01
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CardioVascular BioTherapeutics, Inc.:
Peripheral Arterial Disease
Intermittent Claudication
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms