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. 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
Information provided by (Responsible Party):
University of Wisconsin, Madison

June 2, 2009
June 4, 2009
December 5, 2014
May 2009
December 2013   (Final data collection date for primary outcome measure)
Death or amputation [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00913900 on Archive Site
Vascular hemodynamics and function [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease
Stem Cell Revascularization in Patients With Critical Limb Ischemia
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.
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.
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Critical Limb Ischemia
  • Arterial Occlusive Disease
  • Vascular Diseases
Biological: autologous CD133+ cells
Intramuscular injection
  • Active Comparator: Autologous Stem cells (CD133+)
    Intramuscular injection
    Intervention: Biological: autologous CD133+ cells
  • Placebo Comparator: Control
    Intramuscular Injection
    Intervention: Biological: autologous CD133+ cells
Raval AN, Schmuck EG, Tefera G, Leitzke C, Ark CV, Hei D, Centanni JM, de Silva R, Koch J, Chappell RG, Hematti P. Bilateral administration of autologous CD133+ cells in ambulatory patients with refractory critical limb ischemia: lessons learned from a pilot randomized, double-blind, placebo-controlled trial. Cytotherapy. 2014 Dec;16(12):1720-32. doi: 10.1016/j.jcyt.2014.07.011. Epub 2014 Sep 18.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Amish N Raval, MD U.Wisconsin School of Medicine and Public Health
University of Wisconsin, Madison
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP