PADPhase 1/2NCT00390767
Safety Study of MultiGeneAngio in Patients With Peripheral Arterial Disease (PAD)
A Phase 1/2 study testing MultiGeneAngio in people with PAD and Claudication, run by MultiGene Vascular Systems Ltd. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and activity of increasing doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with peripheral arterial disease. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- PAD, Claudication
- What is being tested?
- MultiGeneAngio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2006to Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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).
- Angiographic or equivalent anatomic evidence (MRA) of arterial occlusive disease (>70%) in the distal common femoral artery or superficial femoral artery and its branches of at least one leg within 12 months prior to screening.
- Postmenopausal (females),surgically sterile, or use adequate birth control.
Who cannot join
- Presence of significant inflow disease [defined as >50% stenosis] in the distal aorta, common or external iliac as assessed by conventional angiogram, digital subtraction angiography (DSA), or magnetic resonance angiography (MRA) performed < 1 year prior to screening.
- Critical limb ischemia, either chronic or acute ischemia manifested by rest pain, ulceration, or gangrene (Category 4 through 6 of Society for Vascular Surgery [SVS] classification [Rutherford]).
- History of malignant neoplasm (except curable non-melanoma skin malignancies).
- Renal failure (serum creatinine >2.0 mg/dL) or end-stage renal disease(requiring hemodialysis or renal replacement therapy).
- Significant hepatic disease (>3-fold elevation in ALT/AST).
- HBV or HCV carriers.
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- Severe pulmonary disease (e.g. severe chronic obstructive pulmonary disease).
- Subjects with Acute Stroke within 6 months prior to screening.
- Subjects with uncontrolled diabetes mellitus.
- Specific ophthalmologic conditions that preclude retinal photography,vascular lesions of the anterior segment of the eye, proliferative retinopathy, age-related macular degeneration or intra-ocular surgery within 6 months prior to enrollment.
- Gross obesity (BMI≥40).
- Buerger's disease or other forms of inflammatory arteritis.
- Class IV congestive heart failure, as defined by the New York Heart Association or a myocardial infarction within 6 months prior to screening.
- Subject with deep vein thrombosis within 3 months prior to screening.
- Inability to complete the standardized treadmill protocol for reasons other than claudication including symptoms such as angina, dyspnea, joint pains, or excessive fatigue.
- Percutaneous intervention or surgical revascularization in the index lower limb within 6 months prior to enrollment.
- Heart angioplasty with or without stent or coronary bypass surgery within the past 6 months.
- Participation in a structured exercise treatment protocol within 30 days prior to screen testing.
- Subject is planning to participate in a structured exercise treatment protocol during the 180 days following administration of the investigational product.
- Participation in a previous gene transfer trial in which the subject received active investigational product (placebo subjects are eligible).
- Concurrent or prior participation in another clinical trial within 30 days prior to screen testing.
- Chronic use of Cox-2 inhibitors, defined as subjects needing daily use of the agent for more than 30 days prior to screening.
- Subject is taking any of the following drugs for life-threatening conditions or as part of a life-sustaining treatment: Cyclosporine (Sandimmune®),Systemic androgens/anabolic steroids, systemic corticosteroids.
- History of bleeding diathesis (e.g. hemophilia due to Factor VIII or IX deficiency).
- Pregnancy or breast-feeding.
- Uncontrolled hypertension or significant hypotension.
- Immunodeficiency states (e.g, current HIV positivity, or organ transplant recipient) or subject receiving immunosuppressive medications.
- Alcohol or other substance abuse.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan and VA Ann Arbor Health Systems
Ann Arbor, Michigan, 48109-0311
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: A Phase I Safety, Dose Escalating Study of MultiGeneAngio in Patients With Peripheral Arterial Disease
The purpose of this study is to evaluate the safety and activity of increasing doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with peripheral arterial disease.
Read the detailed description
Approximately 16 million patients worldwide (1 in 20 people over the age of 50) suffer from peripheral arterial disease(PAD). PAD is characterized by narrowing or occlusion of vessels supplying blood to the lower limbs, most often due to atherosclerosis. Symptoms of PAD include claudication that may progress to critical limb ischemia manifested by rest pain, tissue loss and gangrene, which eventually may necessitate amputation.
MultiGeneAngio is a cell therapy-based product developed for treatment of patients with PAD secondary to narrow or blocked arteries in the legs. MultiGeneAngio is composed of endothelial and smooth muscle cells that are isolated from a short vein segment stripped from the patient's arm. After isolation the cells are expanded, characterized, and gene modified by transfer of angiogenic genes.
MultiGeneAngio is a clear cell suspension injected intra-arterially at the site of blockage using a standard diagnostic catheter, in order to create and expand new collateral arteries, and thereby improve blood flow to an ischemic limb.
Comprehensive pre-clinical studies, as well as clinical experience with PAD patients suffering from claudication showed that production and administration of MultiGeneAngio was feasible and safe, as no apparent drug-related adverse events have been observed. Moreover, follow-up data of peak walking times imply a beneficial trend of this efficacy end-point. Additional follow-up data will continue to be collected to help evaluate the safety and efficacy of MultiGeneAngio.
- Conditions
- PAD, Claudication
- Being tested
- MultiGeneAngio
- Keywords
- Peripheral arterial disease, Peripheral vascular disease, Claudication, Cell therapy, Gene therapy, Endothelial cells, Smooth muscle cells, Angiogenesis
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiGeneAngioBiological
Also called MGA
Escalating doses of MultiGeneAngio, one dose per patient administered as one treatment, infused intra-arterially
| Study group | Role | What they receive |
|---|---|---|
| MultiGeneAngio | Experimental | Escalating doses of MultiGeneAngio Receives: Biological: MultiGeneAngio |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of MultiGeneAngio will be assessed by monitoring adverse events
Measured: Up to 15 years after treatment
Secondary outcomes (1)
Improvement in PAD symptoms
Measured: Up to one year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2010
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PADStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- MultiGene Vascular Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam L Teichman, MD, Study director, Independent consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390767
- Sponsor's protocol ID
- MGVS-MGA 001
- Other IDs
- Protocol #0504-703 (NIH RAC)
- Status last verified
- Mar 2015
- First submitted
- 19 Oct 2006
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Staudacher DL, Preis M, Lewis BS, Grossman PM, Flugelman MY. Cellular and molecular therapeutic modalities for arterial obstructive syndromes. Pharmacol Ther. 2006 Jan;109(1-2):263-73. doi: 10.1016/j.pharmthera.2005.08.005. Epub 2005 Oct 21.
PubMed 16243400Grossman PM, Mohler ER 3rd, Roessler BJ, Wilensky RL, Levine BL, Woo EY, Upchurch GR Jr, Schneiderman J, Koren B, Hutoran M, Gershstein D, Flugelman MY. Phase I study of multi-gene cell therapy in patients with peripheral artery disease. Vasc Med. 2016 Feb;21(1):21-32. doi: 10.1177/1358863X15612148. Epub 2015 Nov 19.
PubMed 26584888
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety, Dose Escalating Study of MultiGeneAngio in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00390767
- Acronym / sponsor ID
- MGVS-MGA 001
- Conditions
- PAD, Claudication
- Keywords
- Peripheral arterial disease, Peripheral vascular disease, Claudication, Cell therapy, Gene therapy, Endothelial cells, Smooth muscle cells, Angiogenesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MultiGene Vascular Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and activity of increasing doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with peripheral arterial disease.
Detailed description
Approximately 16 million patients worldwide (1 in 20 people over the age of 50) suffer from peripheral arterial disease(PAD). PAD is characterized by narrowing or occlusion of vessels supplying blood to the lower limbs, most often due to atherosclerosis. Symptoms of PAD include claudication that may progress to critical limb ischemia manifested by rest pain, tissue loss and gangrene, which eventually may necessitate amputation.
MultiGeneAngio is a cell therapy-based product developed for treatment of patients with PAD secondary to narrow or blocked arteries in the legs. MultiGeneAngio is composed of endothelial and smooth muscle cells that are isolated from a short vein segment stripped from the patient's arm. After isolation the cells are expanded, characterized, and gene modified by transfer of angiogenic genes.
MultiGeneAngio is a clear cell suspension injected intra-arterially at the site of blockage using a standard diagnostic catheter, in order to create and expand new collateral arteries, and thereby improve blood flow to an ischemic limb.
Comprehensive pre-clinical studies, as well as clinical experience with PAD patients suffering from claudication showed that production and administration of MultiGeneAngio was feasible and safe, as no apparent drug-related adverse events have been observed. Moreover, follow-up data of peak walking times imply a beneficial trend of this efficacy end-point. Additional follow-up data will continue to be collected to help evaluate the safety and efficacy of MultiGeneAngio.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MultiGeneAngio | Experimental | Biological: MultiGeneAngioEscalating doses of MultiGeneAngio |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
- 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).
- Angiographic or equivalent anatomic evidence (MRA) of arterial occlusive disease (>70%) in the distal common femoral artery or superficial femoral artery and its branches of at least one leg within 12 months prior to screening.
- Postmenopausal (females),surgically sterile, or use adequate birth control.
Key exclusion criteria (28 listed)
- Presence of significant inflow disease [defined as >50% stenosis] in the distal aorta, common or external iliac as assessed by conventional angiogram, digital subtraction angiography (DSA), or magnetic resonance angiography (MRA) performed < 1 year prior to screening.
- Critical limb ischemia, either chronic or acute ischemia manifested by rest pain, ulceration, or gangrene (Category 4 through 6 of Society for Vascular Surgery [SVS] classification [Rutherford]).
- History of malignant neoplasm (except curable non-melanoma skin malignancies).
- Renal failure (serum creatinine >2.0 mg/dL) or end-stage renal disease(requiring hemodialysis or renal replacement therapy).
- Significant hepatic disease (>3-fold elevation in ALT/AST).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultiGeneAngioAlso: MGAEscalating doses of MultiGeneAngio, one dose per patient administered as one treatment, infused intra-arterially | Biological | MultiGeneAngio |
Primary outcome
The safety of MultiGeneAngio will be assessed by monitoring adverse events
Time frame: Up to 15 years after treatment
1 secondary outcome
Improvement in PAD symptoms
Time frame: Up to one year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- Background: PubMed 16243400Staudacher DL, Preis M, Lewis BS, Grossman PM, Flugelman MY. Cellular and molecular therapeutic modalities for arterial obstructive syndromes. Pharmacol Ther. 2006 Jan;109(1-2):263-73. doi: 10.1016/j.pharmthera.2005.08.005. Epub 2005 Oct 21.
- Derived from this study: PubMed 26584888Grossman PM, Mohler ER 3rd, Roessler BJ, Wilensky RL, Levine BL, Woo EY, Upchurch GR Jr, Schneiderman J, Koren B, Hutoran M, Gershstein D, Flugelman MY. Phase I study of multi-gene cell therapy in patients with peripheral artery disease. Vasc Med. 2016 Feb;21(1):21-32. doi: 10.1177/1358863X15612148. Epub 2015 Nov 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam L Teichman, MD study director
Independent consultant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MultiGeneAngio in people with PAD and Claudication, run by MultiGene Vascular Systems Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of MultiGeneAngio will be assessed by monitoring adverse events (time frame: Up to 15 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00390767, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.