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

• ClinicalTrials.gov Identifier: NCT00913900
• Recruitment Status: Terminated
• First Posted: June 4, 2009
• Last Update Posted: December 5, 2014
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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 Design

• 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
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 90 Years (Adult, Older Adult)
• 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

Contacts and Locations

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

Publications of Results:

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.

• 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
• 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:

Vascular Diseases; Arterial Occlusive Diseases; Ischemia; Pathologic Processes; Cardiovascular Diseases