NCT00278603

Brief Summary

Severe peripheral vascular disease of the legs causes narrowing of the blood vessels in the legs, which keeps the blood from flowing adequately through these vessels. This study is designed to examine whether treating patients with their own previously collected blood stem cells will improve blood flow in the most severely affected leg. Blood stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

4 years

First QC Date

January 15, 2006

Last Update Submit

April 9, 2012

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • The Primary outcome is safety. Safety parameters are survival, and complications related to therapy such as bleeding, infection, acute thrombus or calcification.

    2 years after transplant

Interventions

Stem Cell TransplantationBIOLOGICAL

Autologous Hematopoietic Stem Cell Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atherosclerotic ischemic peripheral vascular disease with rest pain defined as pain that occurs at night or at rest that involves the foot and is a sign of end stage vascular disease and / or ischemic lower extremity ulcers due to infra-inguinal disease and/or peak walking time of 1 to 6 minutes on two exercise tests separated by 2 weeks on graded treadmill.
  • Either a or b
  • Ankle brachial index (ABI) \< 1.0.
  • Doppler waveforms at posterior tibial artery and dorsalis pedis artery are monophasic with toe pressure \< 30 mmHg.
  • A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi- segment disease, or extensive infra-popliteal disease not amenable to a vascular graft.
  • Age \> 18 years old.

You may not qualify if:

  • Popliteal vascular entrapment syndrome
  • Lower Extremity infection or infected ulcer
  • Hypercoagulable state
  • HIV positive
  • HBsAg positive
  • Uncontrolled arrhythmia, that is, persistence of an arrhythmia despite medical therapy
  • Unstable angina
  • Thrombocytopenia \< 100,000/ul
  • Anemia that cannot be transfused to a hemoglobin greater than 10 g/dl
  • Leukemia or myelodysplasia
  • Allergy to E coli or its products
  • Patients with metal in their bodies cannot undergo MRIs (MRA). Therefore, patients with, cochlear implants, or aneurysm clips are not eligible. Coronary artery stents are not a contraindication. Patients with pacemakers are still candidates provided they have normal creatinine (\< 1.1 mg/dl) and can receive contrast dye (no allergy) for angiogram instead of MRA.
  • Patients who are pregnant
  • Poorly controlled diabetes (HbA1c \> 6.5)
  • Current malignancy, except squamous cell or basal cell skin cancers thought to be easily controlled.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • William Pearce, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2006

First Posted

January 18, 2006

Study Start

October 1, 2004

Primary Completion

October 1, 2008

Study Completion

June 1, 2009

Last Updated

April 11, 2012

Record last verified: 2012-04

Locations

US(1)