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About
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for revascularization.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed critical limb ischemia ASCs will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of the adipose tissue derived stem cells. In addition, peripheral blood will be collected for isolation of platelet rich plasma, which are then combined with the ASC's for intramuscular injection into the lower limb.
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Inclusion criteria
Age ~ 18 years
Existence of limb ischemia, with clinical presentation corresponding to Rutherford Categories 2-6 as defined in the reporting standards adopted by \ the Society of Vascular Surgeons, or corresponding to the Leriche-Fontaine Classification, stages II, III, or IV
Patients with, ischemia and ischemic ulceration provided patient have angiographic evidence of vascular compromise and is not a candidate for revascularization
Stable and on optimal medical management for > 60 days as follows:
Clopidogrel/aspirin therapy or other anticoagulation therapy, cholesterol- lowering agent, and⁄or antihypertensive medication
Hematocrit ≥ 28.0%, White Blood Cell count ≤14,000, Platelet count ≥ 50,000
Creatinine ≤ 2.5 mg/dL, and INR ≤ 1.6 (unless taking warfarin) or PTT < 1.5× control (to avoid bleeding complications). INR values for patients taking warfarin will be corrected prior to the procedure
Patient meets at least one of the following diagnostic criteria for the index limb:
At least one non-healing distal extremity ischemic ulcer as confirmed by a vascular surgeon
Up to date on all age and gender appropriate cancer screening per American Cancer Society
Exclusion criteria
Female who is pregnant or nursing, or is of childbearing potential and not using a reliable method of contraception
Any medical problems contraindicating tumescent syringe liposuction
Life expectancy < 6 months
Patient determined to be nonsurgical candidate due to reasons such as
Systolic blood pressure (supine) ≤ 90 mmHg
Resting heart rate > 100 bpm
Poorly controlled diabetes mellitus (HgbA1c > 10%)
Life-threatening complications of limb ischemia necessitating immediate amputation
Uncorrected iliac artery occlusion on index side unless corrected with stent
Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6)
Active clinical infection within one week of enrollment
Treatment with immunosuppressant drugs
Known drug or alcohol dependence, or any other factors which will interfere with the study conduct or interpretation of the results
Not suitable to participate in the opinion of the principal investigator
History cancer (other than non-melanoma skin cancer or in situ cervical cancer) within five years preceding study entry
Unwilling and/or not able to give written informed consent
Primary purpose
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Interventional model
Masking
0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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