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

NCT00913900 | Terminated Phase 1 DMC

• 1 other identifier: H-2009-0008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Limb Ischemia; Arterial Occlusive Disease; Vascular Diseases

Keywords

Arterial Occlusive Diseases; Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Death or amputation

  6 months

Secondary Outcomes (1)

• Vascular hemodynamics and function

  6 months

Study Arms (2)

Autologous Stem cells (CD133+)

ACTIVE COMPARATOR

Intramuscular injection

Biological: autologous CD133+ cells

Control

PLACEBO COMPARATOR

Intramuscular Injection

Biological: autologous CD133+ cells

Interventions

autologous CD133+ cells BIOLOGICAL

Intramuscular injection

Autologous Stem cells (CD133+); Control

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Gangrene(Rutherford 6) or pre-existing major tissue loss
• Unstable Angina, MI, stroke, CHF (class III or IV) within 6 months of study treatment

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• 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.

  PMID: 25239491 RESULT

• 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.

  PMID: 35802393 DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Arterial Occlusive Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Amish N Raval, MD

  U.Wisconsin School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

US (1)