CLINICAL TRIAL

Injection of cBMA aspirate into the index leg for Ischemia

Recruiting · 18+ · Female · Indianapolis, IN

This study is evaluating whether bone marrow cells can help prevent complications after lower extremity amputation.

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About the trial for Ischemia

Eligible Conditions
Peripheral Arterial Disease · Ischemia · Peripheral Arterial Disease (PAD) · Critical Limb Ischemia (CLI) · Vascular Diseases

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.

Experimental Group 1
Injection of cBMA aspirate into the index leg
BIOLOGICAL
Experimental Group 2
Injection of cBMA aspirate into the index leg
BIOLOGICAL
Experimental Group 3
Injection of cBMA aspirate into the index leg
BIOLOGICAL

Eligibility

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients who need to have a below-the-knee amputation, as decided by an independent vascular specialist. show original
If an ulcer or gangrene is present, it is located further down the leg (towards the ankle), in order to allow room for four separate injections, each four centimetres apart. show original
The study investigators have determined that BKA can be safely performed up to 30 days after screening show original
Any female of child-bearing potential who is willing to use one form of birth control for the duration of the study and agrees to a blood or urine pregnancy test at screening is eligible for participation in the study. show original
The patient should be aged between 40 and 90 years old. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Primary follow up in a 12 month period
Screening: ~3 weeks
Treatment: Varies
Reporting: Primary follow up in a 12 month period
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Primary follow up in a 12 month period.
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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.

Number of participants with treatment-related adverse events occurring during the enrollment period as assessed by the Investigator using the CTCAE 4.0 scale.
PRIMARY FOLLOW UP IN A 12 MONTH PERIOD
Safety will be evaluated by review of treatment related AEs during the 12-month follow-up period. The study will be terminated in the event of a Grade 4-5 unexpected event based on the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Treatment-related AEs will be categorized overlapping systems and severities. Three categories of systems are cardiovascular, respiratory, or infectious. Two categories of severity will be serious adverse (SAE) and major adverse cardiac events (MACE). Binomial confidence Intervals at the 95% confidence level and p-values for these 3 groups will be calculated. Since previous trials have not reported AEs with cBMA treatment, confidence intervals will be generated by the method of the Wilson Score Interval.
PRIMARY FOLLOW UP IN A 12 MONTH PERIOD
The role of MSCs injected in human skeletal muscle at the time of below knee amputation as evidenced by recruitment of proangiogenic hematopoietic cells into sites of ischemia.
PRIMARY FOLLOW UP IN A 12 MONTH PERIOD
Continuous confidence intervals at the 95% level will be constructed to explore differences among the time-tiered administration of MSC for the quantity of capillary density in muscle fibers, examine changes in morphology, and the recruitment of HIF-1a/SDF-1/CXCR4 to ischemic muscle.
PRIMARY FOLLOW UP IN A 12 MONTH PERIOD
Time period of retention of allogeneic MSCs in harvested human skeletal muscle tissue post-MSC implantation as measured by immunohistochemical staining and number of MSCs per section of skeletal muscle at each time point .
PRIMARY FOLLOW UP IN A 12 MONTH PERIOD
Sections of skeletal muscle collected from each injection site will be stained with specific antibodies for MSC specific markers and the number of MSCs will be counted in each field under a microscope.
PRIMARY FOLLOW UP IN A 12 MONTH PERIOD

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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