Safety Study of MultiGeneAngio in Patients With Peripheral Arterial Disease (PAD)

NCT00390767 | Unknown Phase 1 DMC

• 2 other identifiers: MGVS-MGA 001Protocol #0504-703 (NIH RAC)
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

PAD; Claudication

Keywords

Peripheral arterial disease; Peripheral vascular disease; Claudication; Cell therapy; Gene therapy; Endothelial cells; Smooth muscle cells; Angiogenesis

Outcome Measures

Primary Outcomes (1)

• The safety of MultiGeneAngio will be assessed by monitoring adverse events

  Up to 15 years after treatment

Secondary Outcomes (1)

• Improvement in PAD symptoms

  Up to one year after treatment

Study Arms (1)

MultiGeneAngio

EXPERIMENTAL

Escalating doses of MultiGeneAngio

Biological: MultiGeneAngio

Interventions

MultiGeneAngio BIOLOGICAL

Escalating doses of MultiGeneAngio, one dose per patient administered as one treatment, infused intra-arterially

Also known as: MGA

MultiGeneAngio

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MultiGene Vascular Systems Ltd.: lead

Study Sites (2)

University of Michigan and VA Ann Arbor Health Systems

Ann Arbor, Michigan, 48109-0311, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Publications (2)

• 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.

  PMID: 16243400 BACKGROUND

• Grossman 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.

  PMID: 26584888 DERIVED

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Sam L Teichman, MD

  Independent consultant

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 20, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2024
• Last Updated: March 5, 2015

Record last verified: 2015-03

Locations

US (2)