Clinical trial NCT00278603: Stem Cell Injection for Peripheral Vascular Disease
Official title: Hematopoietic Stem Cell Injection for Peripheral Vascular Disease: Induction of Neoangiogenesis. A Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Vascular Disease
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2006-01-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The Primary outcome is safety. Safety parameters are survival, and complications related to therapy such as bleeding, infection, acute thrombus or calcification.
timeFrame: 2 years after transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: William Pearce, MD
role: PRINCIPAL_INVESTIGATOR
References: