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Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease (SCRIPT-CLI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00913900
Recruitment Status : Terminated (Failure to mobilize adequate CD34+ stem cells for minimum study treatment dose.)
First Posted : June 4, 2009
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
Peripheral artery disease (PAD) due to leg artery blockages can result in painful leg muscles, skin ulcers and infection due to poor blood flow. In severe forms, the only treatment may be amputation. Adult stem cells injected into affected legs may cause new blood vessel formation and improve blood flow. The purpose of this study is to determine the feasibility and safety of injecting adult stem cells into the leg muscles of patients with severe PAD, in an attempt to improve blood flow.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Arterial Occlusive Disease Vascular Diseases Biological: autologous CD133+ cells Phase 1

Detailed Description:
Lower extremity peripheral artery disease (PAD) is a common, debilitating and potentially life-threatening illness. Obstructive PAD can progress to limb-threatening ischemia with rest pain, ulcers, and gangrene requiring amputation unless blood flow to the ischemic limb can be restored. Surgical revascularization options are often limited by arteries that are too small to bypass. Patient co-morbidities also make surgical options risky. Percutaneous revascularization techniques are similarly limited by small distal artery caliber, technical difficulty and high restenosis rates. Amputation may be the only treatment option for non-healing ulcers or gangrene. Direct intramuscular injection of adult stem cells may result in improved lower extremity perfusion, symptomatic improvement and limb salvage in patients with critical limb ischemia not optimal for conventional revascularization. This study aims to demonstrate the safety and feasibility of this therapeutic approach.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stem Cell Revascularization in Patients With Critical Limb Ischemia
Study Start Date : May 2009
Primary Completion Date : December 2013
Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: Autologous Stem cells (CD133+)
Intramuscular injection
Biological: autologous CD133+ cells
Intramuscular injection
Placebo Comparator: Control
Intramuscular Injection
Biological: autologous CD133+ cells
Intramuscular injection



Primary Outcome Measures :
  1. Death or amputation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Vascular hemodynamics and function [ Time Frame: 6 months ]


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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory critical limb ischemia (Rutherford Score 4/5)
  • Not optimal for surgical or catheter-based revascularization
  • Obstructive atherosclerosis of at least 1 major artery in both limbs
  • Ankle-Brachial Index <0.6 or Absolute Ankle pressure <60mmHg or toe pressure <40mmHg or pulse volume recording that is flat or barely pulsatile

Exclusion Criteria:

  • Gangrene(Rutherford 6) or pre-existing major tissue loss
  • Unstable Angina, MI, stroke, CHF (class III or IV) within 6 months of study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913900


Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Amish N Raval, MD U.Wisconsin School of Medicine and Public Health

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00913900     History of Changes
Other Study ID Numbers: H-2009-0008
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University of Wisconsin, Madison:
Arterial Occlusive Diseases
Vascular Disease

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Arterial Occlusive Diseases
Pathologic Processes
Cardiovascular Diseases