NCT00311805

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

6.7 years

First QC Date

April 4, 2006

Last Update Submit

March 30, 2015

Conditions

Peripheral Artery DiseaseSevere Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

  • Safety of Intramuscular administration of CD34-positive cells

    All

Secondary Outcomes (1)

  • Functional improvement

    Week 12, Month 6, Month 12

Study Arms (3)

1

ACTIVE COMPARATOR
Biological: Autologous Stem Cells (CD34+)

2

ACTIVE COMPARATOR
Biological: Autologous Stem Cells (CD34+)

3

PLACEBO COMPARATOR
Biological: Autologous Stem Cells (CD34+)

Interventions

Autologous Stem Cells (CD34+)BIOLOGICAL

Intramuscular Injections

123

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cardiology, PC

Birmingham, Alabama, 35211, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Interventions

Antigens, CD34

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antigens, CDAntigens, DifferentiationAntigens, SurfaceAntigensBiological FactorsBiomarkers

Study Officials

  • Douglas W. Losordo, M.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 6, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2012

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

US(2)