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

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