The purpose of this study is to determine whether treatment with umbilical cord blood stem cells will improve blood flow to the most severely affected leg of a participant with medically refractory and non-surgical peripheral vascular disease of the lower extremity.
Umbilical cord blood is a safe alternative source of stem cells used for decades in hematopoietic stem cell transplants for malignancies. There is also a reported decreased incidence of acute GVHD compared to matched unrelated donor transplants.A cord blood registry will be searched for suitable units with compatibility in the ABO and HLA systems. The minimum total nucleated cell dose required which would be 1.0 x 107/kg, and one unit of cells will be procured to meet this requirement. Although it is likely that the transplanted cord blood cells will be rejected over time, we hypothesize that while they remain in the host's tissue these cells will be producing and releasing cytokines, growth factors and other humoral factors that might promote vasculogenesis by stimulating endogenous stem cells and endothelial cells. Since there is no need to collect the patient's own stem cells, the patient's cardiovascular system will not be subjected to any stress due to the leukapheresis procedure itself. No injections of exogenous growth factors, which have been associated with thrombosis, would be required to mobilize the patient's own stem cells. The procedure could conceivably even be performed in its entirety on an outpatient basis. A total of 25 patients will be enrolled in the study. Patients will be followed for 24 months after the procedure with evaluation visits one day after the transplant and then at one month, six, twelve and twenty four months post-treatment. The visit one day after the transplant will involve a history and physical with a leg exam, a CBC and a chemistry panel to evaluate for possible infection, or other adverse event.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
The cord blood stem cells will be simply injected intramuscularly in the leg. 30 minutes prior to stem cell injection the patients will receive Vancomycin 1 gram IVPB x1 as a prophylactic measure. Patients will also receive Ativan 0.5 to 1 mg PO x 1 and Dilaudid 0.5 to 1 mg IV x1 to alleviate the discomfort of the procedure. Cells will be injected by means of a 22 gauge sterile spinal needle after topical anesthesia of the injection site. The concentration will be at least 2 x 107 total nucleated cells per ml in phosphate buffered saline (PBS) with 5% human serum albumin (Baxter, Deerfield Illinois).
Northwestern University
Chicago, Illinois, United States
Ankle brachial index (ABI), a 15% increase will be considered improvement
Time frame: Pre-transplant, 1, 6, 12 and 24 months after
Healing of ischemic ulcers
Time frame: Pre-transplant, 1, 6, 12 and 24 months after
Decreased pain level as reported by the patient
Time frame: Pre-transplant, 1, 6, 12 and 24 months after
SF-36 quality of life (QOL)
Time frame: Pre-transplant, 1, 6 , 12, and 24 months after HSC transplant
Walking Impairment Questionnaire
Time frame: Pre-transplant, 1, 6 , 12, and 24 months after HSC transplant
Increase in pain free ambulation time on treadmill by more than 25%
Time frame: Pre-transplant, 1, 6 , 12, and 24 months after HSC transplant
Increase in four meter walk or six minute walk by more than 25%
Time frame: Pre-transplant, 1, 6 , 12, and 24 months after HSC transplant
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