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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

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: MultiGeneAngioExperimental Treatment1 Intervention

Escalating doses of MultiGeneAngio

0 / 19Eligibility criteria met

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

MultiGeneAngio (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00390767 — Phase 1 & 2

Intermittent Claudication Research Study Groups: MultiGeneAngio

Intermittent Claudication Clinical Trial 2023: MultiGeneAngio Highlights & Side Effects. Trial Name: NCT00390767 — Phase 1 & 2

MultiGeneAngio (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00390767 — Phase 1 & 2

~1 spots leftby Sep 2025

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