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Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier:
NCT00311805
First received: April 4, 2006
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

The goal of the study is to determine the safety and possible effectiveness of various doses of autologous (one's own) stem cells, delivered with a needle into the regions of the leg with poor blood flow in patients with blocked leg arteries that results in claudication (pain when walking). Stem cells are primitive cells produced by the bone marrow that can develop into blood cells or other types of cells. In addition to determining whether this new approach is safe, the diagnostic tests may offer preliminary insights into the usefulness of this approach for treating intermittent claudication - the condition where areas in the leg are lacking enough oxygen and blood flow to keep the leg muscle working well, causing pain and cramping upon walking.

This study is a double-blind, randomized study to compare CD34-positive stem cells versus a placebo agent (salt water solution known as normal saline). The patient will have a 3:1 chance of their stem cells versus the placebo. Regardless of a patient receiving placebo or treatment, all patients will undergo all of the pre-treatment phases of this study, which includes the stem cell mobilization and apheresis procedure.


Condition Intervention Phase
Peripheral Artery Disease
Severe Intermittent Claudication
 Biological: Autologous Stem Cells (CD34+)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Injection of Autologous CD34-Positive Stem Cells for Neovascularization and Symptom Relief in Patients With Severe Intermittent Claudication

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Losordo, Douglas, M.D.:

Primary Outcome Measures:
  • Safety of Intramuscular administration of CD34-positive cells [ Time Frame: All ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Functional improvement [ Time Frame: Week 12, Month 6, Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2006
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Biological: Autologous Stem Cells (CD34+)
Intramuscular Injections
Active Comparator: 2 Biological: Autologous Stem Cells (CD34+)
Intramuscular Injections
Placebo Comparator: 3 Biological: Autologous Stem Cells (CD34+)
Intramuscular Injections

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females equal to or greater than 21 years old
  • Patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major vessel in the affected limb(s) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries, which is/are non-reconstructable.
  • Patients with symptoms of Severe Intermittent Claudication in at least 1 lower limb persisting for at least 6 months (Rutherford Class 3).
  • Patients who have a diagnosis of Peripheral Arterial Disease (PAD) in at least 1 lower limb secondary to atherosclerosis, for at least 6 months.

Exclusion Criteria:

  • Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 month preceding screening.
  • Patients with iliac disease amenable to revascularization.
  • Patients judged to be a suitable candidate for surgical or percutaneous revascularization in the limb in which treatment is proposed.
  • Patients with Critical Limb Ischemia (CLI), Rutherford Symptom Score of 4,5, or 6.
  • Patients in who arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311805

Locations
United States, Alabama
Cardiology, PC
Birmingham, Alabama, United States, 35211
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Losordo, Douglas, M.D.
Investigators
Principal Investigator: Douglas W. Losordo, M.D. Northwestern University
  More Information

No publications provided

Responsible Party: Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier: NCT00311805     History of Changes
Other Study ID Numbers: STU00023438/STU00000487, 11931-01
Study First Received: April 4, 2006
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Intermittent Claudication
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013