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Cell Therapy
Cell Therapy for Peripheral Arterial Disease
Phase 1 & 2
Waitlist Available
Research Sponsored by MultiGene Vascular Systems Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Limitation in walking secondary to claudication with a mean peak walking time (PWT) of between 1 and 10 minutes on a standardized Gardner protocol for exercise treadmill test (ETT)
Must not have
History of malignant neoplasm (except curable non-melanoma skin malignancies)
Significant hepatic disease (>3-fold elevation in ALT/AST)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for postmenopausal or sterile individuals, or those using birth control, with peripheral arterial disease (PAD) causing walking limitations due to claudication. They must have specific artery blockages and a history of PAD symptoms in their legs. Excluded are those with severe diseases like heart failure, recent strokes, uncontrolled diabetes, obesity (BMI≥40), certain eye conditions, recent surgeries on the heart or veins in the leg, and anyone who's been in gene transfer trials.
What is being tested?
The study tests MultiGeneAngio cell therapy made from a patient's own cells at different doses to see if it's safe and effective for treating PAD. Patients will receive this treatment to check how well it improves blood flow and reduces symptoms related to poor circulation in their legs.
What are the potential side effects?
While the trial primarily aims to assess safety, potential side effects may include typical risks associated with cell therapies such as immune reactions, infection risk at injection sites, possible pain or swelling where treated. Specific side effects will be monitored closely given that this is a novel treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had leg pain from walking due to artery problems for at least 2 months.
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I can walk only 1-10 minutes due to leg pain.
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I am postmenopausal, surgically sterile, or I use reliable birth control.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of cancer, excluding non-melanoma skin cancers that were curable.
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My liver enzymes are not more than three times the normal limit.
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I have not had a heart attack in the last 6 months and do not have severe heart failure.
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I can't complete a treadmill test due to pain, breathlessness, or extreme tiredness.
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I had a procedure to improve blood flow in my leg within the last 6 months.
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I am currently taking Cyclosporine, steroids, or androgens for a critical condition.
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I have a bleeding disorder like hemophilia.
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My kidney function is severely impaired, indicated by high creatinine or needing dialysis.
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I have severe lung disease.
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I do not have eye conditions that prevent retinal photography or recent eye surgery.
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I have Buerger's disease or another type of inflammation in my arteries.
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I have a weakened immune system due to a condition like HIV or after an organ transplant.
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I have severe leg pain, ulcers, or gangrene due to poor blood flow.
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My diabetes is not under control.
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My BMI is 40 or higher.
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My blood pressure is not well-controlled.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MultiGeneAngioExperimental Treatment1 Intervention
Escalating doses of MultiGeneAngio
Find a Location
Who is running the clinical trial?
MultiGene Vascular Systems Ltd.Lead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
Sam L Teichman, MDStudy DirectorIndependent consultant
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: MultiGeneAngio
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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