A Study of Experimental PLX PAD for Critical Limb Ischemia (severely obstructed arteries limiting bloodflow to limbs)

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Age: 45 to 99 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Critical Limb Ischemia, CLI, Tissue Loss, Revascularization, Unsuitable for Revascularization
Type: Biological study, Phase 3
Target:
10 Participants
Investigator:
Description
This study will test if experimental PLX-PAD is safe, well tolerated and effective for the treatment of critical limb ischemia (CLI). This study is for people with CLI, who are not considered good candidates for surgery or other procedures designed to increase blood flow.

CLI is a severe form of peripheral artery disease (PAD). It is caused by atherosclerosis (hardening of the arteries due to plaques in their inner walls). When the blood vessels that supply blood to the leg narrow, this leads to insufficient blood and oxygen supply to the leg tissues. CLI may be characterized by pain in the foot or leg even when lying at rest. It can also involve foot and leg wounds, which sometimes lead to infection and tissue death. This may lead to the amputation of toes, foot or leg.

PLX-PAD is an experimental medicine. This means that it is not approved for use by the FDA, other than in research studies. PLX-PAD is a cellular therapy, meaning that it contains living cells which are injected into the patient’s muscles. These cells come from a human placenta (the organ that connects the fetus to the uterus). It is collected in a sterile procedure during a planned cesarean section, from healthy female volunteers who donated it. All placenta donors complete a comprehensive questionnaire on their risk of being infected or being a carrier of infectious diseases. Their blood is tested for a vast panel of infectious diseases. Since this research uses human cells, the process for obtaining the cells and preparing them for use is subject to the highest standards.

PLX-PAD cells are added to a fluid which contains:
- dimethyl sulfoxide (DMSO),
- human serum albumin (human blood protein)
- PlasmaLyte (salts solution).

The control solution contains:
- dimethyl sulfoxide (DMSO),
- human serum albumin (human blood protein)
- PlasmaLyte (salts solution)

The control solution does not contain the PLX-PAD cells and is not expected to make your disease better.
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:

  1. Adult male or female subjects between ages 45-99 years of age.
  2. CLI, with minor tissue loss up to the ankle level (Rutherford Category 5)
  3. Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. (If a subject has ABI

    1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg)

  4. Subject unsuitable for revascularization (by any method) in the index leg.
  5. Ischemic lesions in the index leg stable for at least 2 weeks.
  6. Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to a minor amputation).
  7. Under treatment for cardiovascular risk factors: hypertension, hyperlipidemia, diabetes, in accordance with applicable guidelines. Concomitant therapy with a statin and an anti-platelet agent for at least 2 weeks prior to randomization.
  8. Women of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use at least one highly effective birth control method throughout the study.
  9. Signed informed consent form.

Exclusion criteria:

  1. Non-atherosclerotic PAD (e.g. Buerger's disease).
  2. CLI with major tissue loss (Rutherford Category 6) in either leg.
  3. Evidence of active infection (e.g., cellulitis, osteomyelitis).
  4. Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks prior to screening.
  5. Planned or potential need for major/minor amputation or any revascularization within 1 month of study entry upon investigator's judgment.
  6. Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of inadequate inflow to the leg.
  7. Life expectancy of less than 6 months.
  8. Stroke or acute myocardial infarction/unstable angina within 3 months prior to screening.
  9. Severe congestive heart failure symptoms (New York Heart Association [NYHA] Stage IV).
  10. Uncontrolled severe hypertension.
  11. Diabetes mellitus with HbA1c >10%.
  12. Current or history of proliferative retinopathy.
  13. Known Hepatitis B virus or Hepatitis C virus or acquired immunodeficiency syndrome (AIDS) infections.
  14. Subjects with international normalized ratio (INR) >2.5.
  15. Subject on renal replacement therapy or with eGFR <15 mL/min/1.73m2.
  16. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending another investigational device or drug trial(s), unless in long-term follow-up phase.
  17. Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar sympathectomy, wound dressing containing cells or growth factors, or topical platelet derived growth factor.
  18. Known allergies to any of the following: DMSO, human serum albumin, bovine serum albumin.
  19. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine.
  20. Pulmonary disease requiring supplemental oxygen treatment on a daily basis.
  21. Active malignancy or history of malignancy within 5 years prior to study entry.
  22. In the opinion of the investigator, the subject is unsuitable for participating in the study.
  23. Inability to understand and provide an informed consent.
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
If you agree to take part in this research study, you will receive $50.00 for each completed study visit.
Resources
Schedule
Study duration and period
You will be in this study for between 1 and 3 years. You will need to visit the research site about 17 times. The first 2 visits will take place during a screening period where you will be evaluated for participation in the study. We will follow-up with you for 12 months (1 year) to 36 months (3 years), depending on the date you entered into the study and on the date of study end. During this period, you will be asked to come to the study site on the following months: 1, 2, 3, 4, 5, 6, 9, 12, and possibly 16, 20, 24, 28, 32 and 36. You might be asked to come for more visits if your study doctor thinks it is necessary.
Recruitment period
From Feb. 5, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Critical Limb Ischemia (CLI)