A Study of Experimental Blood Derived Autologous Angiogenic Cell Precursor (type of stem cell) Therapy for Critical Limb Ischemia

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Critical Limb Ischemia, CLI
Type: Biological study, Phase 2
Target:
20 Participants
Investigator:
Description
Peripheral Artery Disease (PAD) is a common, progressive circulatory disease. It sometimes advances to Critical Limb Ischemia (CLI). CLI symptoms can be painful and lead to sores and in some cases amputation.

This study will test the safety and effectiveness of injecting Angiogenic Cell Precursors (ACPs) into the muscles of your leg and foot. ACPs are specific stem cells collected from your blood. This experimental study treatment will be used to relieve symptoms of Critical Limb Ischemia.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Subject is diagnosed with critical limb ischemia.
  • Subject has hemodynamic indicators of severe peripheral arterial occlusive disease.
  • Subject is not a candidate for standard revascularization treatment options for peripheral arterial disease.
  • Subject must be on standard of care medical therapy for peripheral vascular disease.
  • Male or female age 18 and above.
  • Non-pregnant, non-lactating female.
  • Subject is able to understand and provide voluntary signed informed consent.

Exclusion criteria:

  • Uncorrected aorto-iliac occlusive disease.
  • Subjects who, in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation in a time frame shortly after administration of the IMP (investigational drug or placebo).
  • Advanced Critical Limb Ischemia (CLI) presenting as severe ischemic or dry gangrene.
  • Lower extremity non-treated active infection.
  • Hypercoagulable state.
  • Subject received a blood transfusion during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
  • Inability to communicate that may interfere with clinical evaluation.
  • Recent major non-vascular operation.
  • Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure.
  • Severe aortic stenosis.
  • Renal failure.
  • Hepatic failure.
  • Anemia.
  • Major stroke.
  • Diagnosis of malignancy.
  • Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms.
  • Severe concurrent disease (other than Peripheral Vascular Disease (PAD)).
  • Bleeding diathesis.
  • Participation at the same time in another investigational product or device study.
  • Chronic cytotoxic drug treatment.
  • Life expectancy of less than 6 months.
  • Subject unlikely to be available for follow-up.
  • Acute worsening of CLI.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
We will pay you $75 for in-person visit to cover out of pocket travel expenses. You will receive up to $675 if you attend all study visits.
Resources
Schedule
Study duration and period
If you agree, you will be in this study for at least 6, and up to 12 months, and will need to visit the research site up to 10 times.
Recruitment period
From Feb. 6, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Critical Limb Ischemia