Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI) (CLI)

This is an interventional treatment trial for Critical Limb Ischemia (CLI) focused on measuring Critical limb ischemia, Peripheral vascular disease, platelet-rich plasma Read More

Inclusion Criteria:

• Is able to provide written informed consent prior to study entry
• Is male or female, 18 - 85 years of age
• CLI with rest pain, tissue loss, or gangrene

• No option for revascularization as a result of one of the following:

  • failed previous revascularization, such as recurrent instant restenosis or graft occlusion.
  • inadequate target vessels as determined by baseline CTA/angiogram at the time of enrollment.
  • or prohibitive medical comorbidities such as high risk cardiovascular or pulmonary disease which would restrict operative procedures
  • Final determination of no option for revascularization will be made by a vascular surgeon not associated with the clinical trial.
• ABI less than 0.7, ankle pressure < 50 mmHg, or toe pressure < 30 mmHg.
• TcPO2 < 40 mmHg
• SPP < 35 mmHg

• Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):

  • Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry),
  • A partner who is physically unable to impregnate the subject (e.g., vasectomized)
  • Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to patient's cell concentrate administration,
  • Intrauterine device (IUD), or
  • Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)
• If female is of childbearing potential, subject must have a negative serum pregnancy test at screening
• Confirmation of age-appropriate cancer screening consistent with the American Cancer Society guidelines

Exclusion Criteria:

• Patients with vascular lesions amenable to percutaneous intervention or where surgical bypass is indicated.
• Any contraindication to stem cell or platelet-rich plasma therapy.
• Isolated aorto-iliac stenoses or occlusions without infra-inguinal disease.
• Pregnancy
• Hemoglobin A1c >10 % on day of enrollment.
• Have an active malignancy or have undergone treatment for a malignancy in the preceding 5 years, with the exception of successful treatment of non-melanoma skin cancer.
• Stage 4 or greater chronic kidney disease (eGFR < 30 ml/min, MDRD estimate)
• Hemoglobin < 10 g/dl.
• Thrombocytopenia < 100,000 platelets/µL.
• Unwilling or unable to comply with follow-up visits.
• Proliferative retinopathy as determined by baseline retinal exam.
• Is unable to refrain from nicotine, caffeine and alcohol for a period beginning 24 hours prior to the treatment visit
• Has received an investigational medication or other study trial participation within 30 days prior to the Treatment Visit