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

December 4, 2014 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death or amputation
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Vascular hemodynamics and function
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Amish N Raval, MD, U.Wisconsin School of Medicine and Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2009-0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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