Use of Vascular Repair Cells (VRC) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia - Full Text View

Sponsored by:	Aastrom Biosciences
Information provided by:	Aastrom Biosciences
ClinicalTrials.gov Identifier:	NCT00468000

Purpose

This study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia.

The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells).

Both groups will receive the standard of care appropriate for their medical condition.

Condition	Intervention	Phase
Peripheral Arterial Disease	Biological: autologous bone marrow cells Biological: electrolyte solution (without cells)	Phase II

MedlinePlus related topics: Vascular Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Use of TRC Autologous Bone Marrow Cells in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia

Further study details as provided by Aastrom Biosciences:

Primary Outcome Measures:

Time to treatment failure (with treatment failure defined as: vascular intervention, bypass surgery, major amputation, doubling of total wound surface area) [ Time Frame: Throughout duration of study (12 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Healing of all wounds in the target limb [ Time Frame: Throughout duration of study (12 months) ] [ Designated as safety issue: No ]
Measurements of wound size [ Time Frame: Throughout duration of study (12 months) ] [ Designated as safety issue: No ]
Percentage of patients undergoing major amputation [ Time Frame: Throughout duration of study (12 months) ] [ Designated as safety issue: No ]
Ankle pressure, ankle brachial pressure index, and toe pressure [ Time Frame: Throughout duration of study (12 months) ] [ Designated as safety issue: No ]
Reduced rest pain; pain free walking [ Time Frame: Throughout duration of study (12 months) ] [ Designated as safety issue: No ]
Incidence of revascularization interventions [ Time Frame: Throughout duration of study (12 months) ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2007
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental The Treatment arm of the study will receive standard of care therapy and injections of the study cellular product.	Biological: autologous bone marrow cells IM injection
Control: Placebo Comparator The Control arm of the study will receive standard of care and placebo injections.	Biological: electrolyte solution (without cells) IM Injection

Detailed Description:

The study will assess the safety and ability of Aastrom TRC autologous bone marrow cells to restore peripheral blood flow affected by critical limb ischemia.

Peripheral arterial disease (PAD), also known as Peripheral Vascular Disease (PVD), occurs when peripheral arteries are damaged by arterial hypertension and/or by the formation of atherosclerotic plaques. PAD is a chronic disease that progressively constricts arterial circulation of limbs. The term critical limb ischemia (CLI) is used for all patients with chronic ischemia rest pain, ulcers, or gangrene in limbs attributable to objectively proven PAD. These sequelae represent the end stage of PAD. PAD is associated with several other clinical conditions, i.e. hypertension, cardiovascular disease, hyperlipidemia, diabetes, tobacco use, obesity and stroke.

The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular injections of the TRC product into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females, 18-90 years of age
Diagnosis of CLI
Infrainguinal occlusive disease, without options for revascularization
No surgical interventions planned
Life expectancy of 2 years
Normal organ and marrow function
Patients with controlled blood pressure (≤ 180/110 mmHg) and established anti-hypertensive therapy
Established anti-platelet therapy

Exclusion Criteria:

Poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] > 10%)
Aortoiliac disease with > 50% stenosis
Wounds with severity greater than Grade 3 on the Wagner Scale
Any known failed ipsilateral revascularization within 2 weeks of enrollment
Previous amputation of the talus, or above in the target limb
Life-threatening ventricular arrhythmia; unstable angina; or, myocardial infarction within 4 weeks of enrollment
Severe congestive heart failure (CHF) (i.e. New York Heart Association [NYHA] Stage IV)
Receiving treatment with hematopoietic growth factors
Infection of the involved extremity(ies)
Active wet gangrenous tissue
Require uninterruptible anticoagulation therapy
Blood clotting disorder
Cancer
End stage renal disease requiring dialysis for more than 6 months prior to enrollment
Pregnant or lactating
Having received medication for thrombolytic therapy (e.g. rTPA or other enzymatic clot busters) within 30 days prior to enrollment
Undergoing hyperbaric oxygen treatment within 2 weeks of enrollment
Concomitant wound treatments with growth factors or tissue engineered products
Receiving anti-angiogenic drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468000

Contacts

Contact: Judy Douville	734-930-5555	mail@aastrom.com
Contact: JoAnn Ayers	734-930-5555	mail@aastrom.com

Show 21 Study Locations

Sponsors and Collaborators

Aastrom Biosciences

Investigators

Principal Investigator:

Anthony J Comerota, MD

Jobst Vascular Center

More Information

No publications provided

Responsible Party:	Aastrom Biosciences, Inc. ( Elmar Burchardt, Vice President, Medical Affairs )
Study ID Numbers:	ABI-55-0610-1
Study First Received:	April 30, 2007
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00468000 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aastrom Biosciences:

Peripheral Arterial Disease
Critical Limb Ischemia
Ischemia
Peripheral Vascular Disease

Study placed in the following topic categories:

Peripheral Vascular Diseases
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia

ClinicalTrials.gov processed this record on May 07, 2009