Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Northwestern University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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
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.
You may not be 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 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.
Clareo Health | Stem Cell Injection for Peripheral Vascular Disease
