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

This study has been terminated.
(Failure to mobilize adequate CD34+ stem cells for minimum study treatment dose.)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00913900
First received: June 2, 2009
Last updated: December 4, 2014
Last verified: December 2014

June 2, 2009
December 4, 2014
May 2009
December 2013   (final data collection date for primary outcome measure)
Death or amputation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00913900 on ClinicalTrials.gov Archive Site
Vascular hemodynamics and function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
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
Both
21 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00913900
H-2009-0008
Yes
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