Efficacy and Safety of Umbilical Cord Blood Injection for Critical Limb Ischemia
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.
Critical Limb Ischemia
Biological: Cord blood stem cell injection
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Umbilical Cord Blood Stem Cell Injection for Critical Limb Ischemia|
- Ankle brachial index (ABI), a 15% increase will be considered improvement [ Time Frame: Pre-transplant, 1, 6, 12 and 24 months after ] [ Designated as safety issue: Yes ]
- Healing of ischemic ulcers [ Time Frame: Pre-transplant, 1, 6, 12 and 24 months after ] [ Designated as safety issue: Yes ]
- Decreased pain level as reported by the patient [ Time Frame: Pre-transplant, 1, 6, 12 and 24 months after ] [ Designated as safety issue: Yes ]
- SF-36 quality of life (QOL) [ Time Frame: Pre-transplant, 1, 6 , 12, and 24 months after HSC transplant ] [ Designated as safety issue: Yes ]
- Walking Impairment Questionnaire [ Time Frame: Pre-transplant, 1, 6 , 12, and 24 months after HSC transplant ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: UBC injection into one leg of PVD pt
25 participants with severe peripheral vascular disease in leg(s) and they do not qualify for surgical treatment.
Biological: Cord blood stem cell injection
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).
Other Name: HSCT
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019681
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Richard Burt, MD||Northwestern University and Northwestern Memorial Hospital|