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

NCT ID: NCT00913900

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Critical Limb Ischemia Arterial Occlusive Disease Vascular Diseases

Keywords

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Arterial Occlusive Diseases Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Autologous Stem cells (CD133+)

Intramuscular injection

Group Type ACTIVE_COMPARATOR

autologous CD133+ cells

Intervention Type BIOLOGICAL

Intramuscular injection

Control

Intramuscular Injection

Group Type PLACEBO_COMPARATOR

autologous CD133+ cells

Intervention Type BIOLOGICAL

Intramuscular injection

Interventions

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autologous CD133+ cells

Intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amish N Raval, MD

Role: PRINCIPAL_INVESTIGATOR

U.Wisconsin School of Medicine and Public Health

Locations

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University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25239491 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35802393 (View on PubMed)

Other Identifiers

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H-2009-0008

Identifier Type: -

Identifier Source: org_study_id