Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease

Vascular Diseases Clinical Trial

— SCRIPT-CLI  

Official title:

Stem Cell Revascularization in Patients With Critical Limb Ischemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00913900
• Other study ID #: H-2009-0008
• Status: Terminated
• Phase: Phase 1
• First received: June 2, 2009
• Last updated: December 4, 2014
• Start date: May 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Disease
• Arterial Occlusive Diseases
• Critical Limb Ischemia
• Ischemia
• Vascular Diseases

Intervention

Biological:
• autologous CD133+ cells
Intramuscular injection

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 pi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or amputation		6 months	Yes
Secondary	Vascular hemodynamics and function		6 months	No