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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00913900
First received: June 2, 2009
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Critical Limb Ischemia
Arterial Occlusive Disease
Vascular Diseases
 Biological: autologous CD133+ cells
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stem Cell Revascularization in Patients With Critical Limb Ischemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Death or amputation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Vascular hemodynamics and function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00913900     History of Changes
Other Study ID Numbers: H-2009-0008
Study First Received: June 2, 2009
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013