Injection of cBMA aspirate into the index leg for Ischemia
This study is evaluating whether bone marrow cells can help prevent complications after lower extremity amputation.
See full descriptionAbout the trial for Ischemia
Treatment Groups
This trial involves 3 different treatments. Injection Of CBMA Aspirate Into The Index Leg is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Eligibility
This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Injection of cBMA aspirate into the index leg will improve 1 primary outcome and 2 secondary outcomes in patients with Ischemia. Measurement will happen over the course of Primary follow up in a 12 month period.
Patient Q & A Section
What are the signs of ischemia?
Decreased ankle brachial pressure index, paresthesia in the lower extremities, and erythrocyte aggregation as measured by digital pulse oximetry can serve as signs of ischemia. These are often the only signs and should raise suspicion of ischemia.
What causes ischemia?
Cerebral infarctions can occur with a variety of vascular causes. There is some evidence that strokes, particularly on the side of the body with the least blood supply, may be more common than previously thought. The risk of stroke on the same side is higher if the parent or first-degree relative has had a stroke. Ischemia can occur in the legs from a variety of causes. Even in the absence of a specific vascular condition with associated symptoms (e.g. claudication or intermittent claudication) it may be worthwhile to look for underlying causes including atherosclerosis and aortic dissection, even if the patient is asymptomatic.
How many people get ischemia a year in the United States?
The American Heart Association estimates 4.7 million Americans are affected by heart disease or have died from heart disease in 2008. More than 100,000 die from ischemia from a stroke or heart attack annually in the United States.
What is ischemia?
Ischemia is a medical condition in which blood supply to a body tissue fails. The most generalised form of ischemia that occurs in humans (and animals) is known as infarctions, which are the cause of a wide variety of disabling diseases.
What are common treatments for ischemia?
Symptoms of ischemia can be treated with aspirin, nitrate, and/or statins. Other treatments may focus on treatment of the underlying ischemic cause (coronary artery disease, stroke, or abdominal aortic aneurysis) or on symptoms related to ischimeria.
Can ischemia be cured?
Ischemia can not be cured. Even if the acute phase of ischemia can be prevented, the severity of ischemia can be practically increased, leading to severe symptoms. An optimal therapy for ischemia needs to be developed.
What is injection of cbma aspirate into the index leg?
Most of the subjects of this study used the method of injection of cbma as the index leg infusion and the method of injection using saline. The patients of the studies used different methods of the index leg injection. The present study was designed to exclude effect of the method.
What is the primary cause of ischemia?
For patients with chest pain, ischemia is the most important secondary diagnosis. The incidence of ischemia is higher for females and for those older than 75 years, and the incidence is lower for those who have had a prior myocardial infarction. The incidence of ischemia is highest in the early part of the evening, the first part of the morning, and in patients who are on the left half of the coronary arteries, the ones supplying the non-left anterior descending artery.
Have there been other clinical trials involving injection of cbma aspirate into the index leg?
The injection of cbma into the calf muscle is a safe, practical alternative to conventional intravenous injection, and may be of value in clinical practice in the absence of an adequate vein.
Does ischemia run in families?
Results from a recent paper demonstrate that familial aggregation of ischemic heart disease and vascular disease can be explained by a generalized increase in the susceptibility to ischemic heart disease and arteriosclerotic vascular disease.
What are the common side effects of injection of cbma aspirate into the index leg?
Although uncommon during treatment, it is important to be aware of the potential side effects of this approach. In such cases, a physician can prescribe local-tissue therapy to reduce the risk of side effects.
Does injection of cbma aspirate into the index leg improve quality of life for those with ischemia?
After injection of cbma aspirate into the leg, people had higher perceptions of general wellbeing and lower perceptions of perceived stress with more positive moods and more positive feelings that cbma did help people with lower limb ischemia. People with leg ischemia also perceived lower levels of stress from cbma, as did people who did not have leg ischemia. There were no statistically significant changes in outcomes that would show that injected cbma had better outcomes than those not injected with cbma. There were no adverse effects. The only difference was that there was a moderate reduction in duration of pain after injection of cbma for those who had leg ischemia.