Clinical trial NCT00913900: Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease
Official title: Stem Cell Revascularization in Patients With Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Critical Limb Ischemia
Arterial Occlusive Disease
Vascular Diseases
Keywords: Arterial Occlusive Diseases
Vascular Disease
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-06-04
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Death or amputation
timeFrame: 6 months
Secondary outcomes:
measure: Vascular hemodynamics and function
timeFrame: 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: U.Wisconsin School of Medicine and Public Health
name: Amish N Raval, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4.