Stem Cell Injection for Peripheral Vascular Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00278603
First received: January 15, 2006
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Disease
Biological: Stem Cell Transplantation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hematopoietic Stem Cell Injection for Peripheral Vascular Disease: Induction of Neoangiogenesis. A Phase I Study

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • The Primary outcome is safety. Safety parameters are survival, and complications related to therapy such as bleeding, infection, acute thrombus or calcification. [ Time Frame: 2 years after transplant ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: October 2004
Study Completion Date: June 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Stem Cell Transplantation
    Autologous Hematopoietic Stem Cell Injection
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

    1. Ankle brachial index (ABI) < 1.0.
    2. 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.

Exclusion Criteria:

  • 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.
  • AST, ALT, or bilirubin more than twice the upper limit of normal.
  • WBC < 2.5 / ul.
  • Any patient who is actively bleeding, including blood on urine dipstick or fecal occult blood.
  • No patient may be re-treated until at least 5 patients have completed 6 months of follow-up with no notable safety findings and evidence of therapeutic efficacy (improved ABI or healing ulcer) occurred at stem cell doses higher than the patient received in this dose escalation study or response occurred in the treated leg and the untreated leg meets eligibility criteria. Re-treated patients must meet eligibility criteria.
  • Patients who smoke unless stop smoking at least two weeks before enrollment and agree not to smoke thereafter.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278603

Locations
United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: William Pearce, MD Northwestern University
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00278603     History of Changes
Other Study ID Numbers: PVD.HSCT2003
Study First Received: January 15, 2006
Last Updated: April 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 16, 2014