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Cell Therapy for Peripheral Arterial Disease
Study Summary
This trial will test if a cell therapy product made from a patient's own cells is safe and effective in treating peripheral arterial disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have a significant narrowing in my lower aorta or pelvic arteries.You have hepatitis B or C virus in your body.I have a history of cancer, excluding non-melanoma skin cancers that were curable.My liver enzymes are not more than three times the normal limit.I had a stroke less than 6 months ago.My kidney function is severely impaired, indicated by high creatinine or needing dialysis.I have severe lung disease.I do not have eye conditions that prevent retinal photography or recent eye surgery.I have Buerger's disease or another type of inflammation in my arteries.I have had leg pain from walking due to artery problems for at least 2 months.I can walk only 1-10 minutes due to leg pain.I am postmenopausal, surgically sterile, or I use reliable birth control.I have not had a heart attack in the last 6 months and do not have severe heart failure.I have had a deep vein thrombosis within the last 3 months.I have not participated in any structured exercise programs in the last 30 days.I am currently taking Cyclosporine, steroids, or androgens for a critical condition.I plan to follow a structured exercise program for 6 months after starting the treatment.I have a weakened immune system due to a condition like HIV or after an organ transplant.I can't complete a treadmill test due to pain, breathlessness, or extreme tiredness.I have a bleeding disorder like hemophilia.I had a procedure to improve blood flow in my leg within the last 6 months.I have a blocked artery in my leg confirmed by a scan within the last year.You have a history of alcohol or drug abuse.I have had heart surgery or a stent placed in the last 6 months.You have participated in a gene transfer trial before and received the actual experimental treatment (placebo recipients are allowed).I have been taking Cox-2 inhibitors daily for more than a month.Your ABI is less than or equal to 0.80, or your TBI is less than 0.70 in at least one leg after resting for 10 minutes.I have severe leg pain, ulcers, or gangrene due to poor blood flow.My diabetes is not under control.My BMI is 40 or higher.My blood pressure is not well-controlled.
- Group 1: MultiGeneAngio
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the target patient population for this research project limited to those who are 60 or older?
"According to the age requirements set out by the research team, the minimum age for enrollment is 50 while the older limit is 80."
Can people with the target condition participate in this research project at this time?
"No, this particular trial is not currently recruiting patients. However, it's important to note that the last date this information was updated was on March 4th, 2015. There are many other trials (236 in total) that are still looking for participants."
How can I become a participant in this experiment?
"This clinical trial is investigating a new treatment for claudication and is looking for 12 test subjects that meet the following criteria: A Doppler-measured ankle-brachial index (ABI) of ≤0.80 or toe-brachial index (TBI) of <0.70 in at least one leg after 10 minutes of rest, History of exercise-limiting intermittent claudication and peripheral arterial disease with symptoms in one or both legs, of at least 2 months duration with no change in symptom severity in the 2 months prior to screening, Postmenopausal (females),surgically"
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