Critical Limb Ischemia Clinical Trial
Official title:
Phase I Study of A Combination Stem Cell Therapy is Safe and Feasible in the Development of Mature Stable Vessels in Ischemic Limbs
The purpose of this research study is to determine if the transplant of a combination of
stem cells obtained from the bone marrow of the same patient will contribute to the
formation of new blood vessels in the severely diseased ischemic limb (leg). In this study
the safe use of this combination of stem cells and its effects on making new blood vessels
will be evaluated.
Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decreases blood
flow to the extremities (mainly feet and legs) and has progressed to the point of severe
pain and even skin ulcers or sores.
LI needs comprehensive treatment since the condition will not improve on its own. The
overall goal of treatment is to reduce the pain and increase blood flow to improve symptoms
or save the leg or feet. In many cases, current options for treatment including medications,
surgery or endovascular procedures have not been successful.
In the last few years, investigators have explored therapies aimed to increase blood flow to
the ischemic vessels by transplanting cells that will promote the development of new vessels
in the diseased leg.
The study hypothesis is based on the concept that the process of formation of new blood
vessels is complex and requires the participation of several types of stem cells and growth
factors. The lack of any of these components will produce vessels which are immature and
unable to provide appropriate blood supply to the leg.
Patients eligible to participate in this study are those suffering from poor circulation or
severe leg blockages, which are not candidates for surgical procedures.
Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells
will be transplanted into the calf muscle of the diseased leg. Clinical studies to evaluate
if the transplant works and is safe will be performed up to 1 year after cell transplant.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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