Miami, Florida, United States, 33136-1015Ĭontact:Contact: Arash Bornak, MD 30 Investigator: Arash Bornak, MD University of Miami Leonard M.Miller School of Medicine (UMMSM)-UHealth Pulmonary and Critical Care Medicine-Rosenstiel Building Location Vascular Center,Department of Surgery,UC Davis Health,4860 Y streetĬontact:Contact: Laura b Jones, Mrs.

Jones 91 Nataly Lessa Magner Investigator: Nasim Hedayati, Dr. Sacramento, California, United States, 95817Ĭontact:Contact: Laura B. Vascular Center ∣ Department of Surgery ∣ UC Davis Health 4860 Y street, Sacramento, CA suite #3400, 95817 Los Angeles, California, United States, 90211Ĭontact:Contact: Suhail Dohad, Dr 31 Investigator: Suhail Dohad, Dr Bldg 55 Rm 334 Orange, CA 92868Ĭontact:Contact: Julie Nguyen 71 Trisha Maris Investigator: Isabella Kuo, Dr.Ĭedars Sinai Medical Center,LA,Beverly Hills,8536 Wilshire Boulevard, Third Floor Inability to understand and provide an informed consent.In the opinion of the investigator, the subject is unsuitable for participating in the study.Active malignancy or history of malignancy within 5 years prior to study entry.Pulmonary disease requiring supplemental oxygen treatment on a daily basis.History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine.Known allergies to any of the following: DMSO, human serum albumin, bovine serum albumin.Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar sympathectomy, wound dressing containing cells or growth factors, or topical platelet derived growth factor.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.

Subject on renal replacement therapy or with eGFR <15 mL/min/1.73m2.

Subjects with international normalized ratio (INR) >2.5.

Known Hepatitis B virus or Hepatitis C virus or acquired immunodeficiency syndrome (AIDS) infections.

Current or history of proliferative retinopathy.

Severe congestive heart failure symptoms (New York Heart Association Stage IV).

Stroke or acute myocardial infarction/unstable angina within 3 months prior to screening.

Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of inadequate inflow to the leg.

Planned or potential need for major/minor amputation or any revascularization within 1 month of study entry upon investigator's judgment.

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.

Evidence of active infection (e.g., cellulitis, osteomyelitis).

CLI with major tissue loss (Rutherford Category 6) in either leg.

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.

Concomitant therapy with a statin and an anti-platelet agent for at least 2 weeks prior to randomization.

Under treatment for cardiovascular risk factors: hypertension, hyperlipidemia, diabetes, in accordance with applicable guidelines.

Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to a minor amputation).

Ischemic lesions in the index leg stable for at least 2 weeks.

Subject unsuitable for revascularization (by any method) in the index leg.

(If a subject has ABI >1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg)

Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg.

CLI, with minor tissue loss up to the ankle level (Rutherford Category 5).

Adult male or female subjects between ages 45-99 years of age.

Recruitment Status, Study Status, Contacts/Locations, Study Design and Outcome Measures

Study Status, Eligibility and Outcome Measures Recruitment Status, Study Status, Contacts/Locations and OversightĬontacts/Locations, Study Status and Eligibility Study Status, Oversight and Study Identification

Dr olay dorsal column stimulator trial