Trial Search Results

Patients With Intermittent Claudication Injected With ALDH Bright Cells

The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells taken from a patient's bone marrow can be placed safely, via intramuscular injections, into their affected calf and lower thigh muscles and improve blood flow and/or peak walking time in patients experiencing pain associated with blocked blood vessels in the leg.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

The University of Texas Health Science Center, Houston

Collaborator: Center for Cell and Gene Therapy, Baylor College of Medicine

Stanford Investigator(s):

Intervention(s):

  • Biological: ALD-301
  • Biological: Placebo (vehicle)

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Patients with atherosclerotic peripheral artery disease with classic claudication
   (exercise-induced pain, cramps, fatigue, or other equivalent discomfort involving
   large muscle groups of the leg(s) that is consistently relieved by rest) or atypical
   leg pain (exertional leg pain that does not begin at rest or does not resolve
   consistently with rest) as defined by the San Diego Claudication Questionnaire.

   2. Age ≥40 years

   3. Resting ankle-brachial index <0.90 or a resting toe-brachial index of <0.70 at
   baseline testing

   4. Presence of significant stenosis or occlusion of infrainguinal arteries including the
   superficial femoral artery, popliteal artery and/or infrapopliteal arteries as
   determined by: Duplex ultrasound imaging (occlusion or focal doubling of peak systolic
   velocity of one or more affected segments) OR lower extremity computed Tomography
   Angiography (CTA) OR lower extremity magnetic resonance angiography (MRA) OR lower
   extremity catheter-based contrast arteriography. Each of these noninvasive and
   invasive anatomic assessments will identify patients with at least a 50% stenosis in
   the affected segment.

Exclusion Criteria:

   1. Presence of any musculoskeletal disease, cardiac or pulmonary disease, or neurological
   disease that limits the patient's ability to walk to fulfill protocol requirements
   (claudication must be the consistent primary exercise limitation)

   2. Inability to complete treadmill testing per protocol requirements.

   3. Ability to walk for more than 12 minutes on the treadmill during treadmill testing.

   4. Patients who identify both legs as equivocally symptomatic or alternate between
   symptomatic legs on the baseline treadmill tests.

   5. Patients with critical limb ischemia (ischemic rest pain or ischemia-related non
   healing wounds or tissue loss (Rutherford categories 4-6).

   6. Recent (<3 months) infrainguinal revascularization (surgery or endovascular
   revascularization) or revascularization planned during study period

   7. Patients with a patent infrainguinal bypass graft in the index limb, with or without
   evidence of a hemodynamically significant stenosis or other defect (kinking,
   pseudoaneurysm, or fistula). Patients with an occluded infrainguinal bypass graft or a
   patent aortobifemoral or femoral-femoral bypass graft are NOT excluded.

   8. Patients with >2+ lower extremity pitting edema

   9. Patients with myelodysplastic syndrome (MDS)

10. Patients who are pregnant or lactating, planning to become pregnant in the next 12
   months, or are unwilling to use acceptable forms of birth control during study
   participation.

11. Congestive Heart Failure hospitalization within the last 1 month prior to enrollment

12. Acute coronary syndrome in the last 1 month prior to enrollment

13. Human Immunodeficiency Virus positive, active Hepatitis B Virus or Hepatitis C Virus
   Disease

14. History of cancer within the last 5 years, except basal cell skin carcinoma

15. Any bleeding diathesis defined as an International Normalized Ratio ≥ 2.0 (off
   anticoagulation therapy) or history of platelet count less than 100,000 or hemophilia

16. Contraindication to magnetic resonance imaging (MRI) (including knee/tibial/fibular
   replacement hardware in the index leg) or known allergy to MRI contrast media

17. Chronic kidney disease [effective Glomerular Filtration Rate <30 by modification of
   diet in renal disease (MDRD) or Mayo or Cockcroft-Gault formula]

18. Uncontrolled diabetes [Hemoglobin A1C (HbA1C)>8.5]

19. Planned change to (initiate or terminate) active involvement in a supervised exercise
   program (e.g., with a trainer, exercise protocol, and goals, such as in a peripheral
   arterial disease, cardiac or pulmonary rehabilitation program) during study
   participation

20. Plans to change medical therapy during the duration of the study, (i.e. patients who
   use cilostazol should remain on a stable dose for four weeks prior to enrollment and
   should not change doses for the 6 months of the study duration.) As always, cilostazol
   can be discontinued if new heart failure or intolerance occurs during study
   participation.

21. Any condition requiring immunosuppressant medications (e.g., for treatment of organ
   transplants, psoriasis, Crohn's disease, alopecia areata).

22. History of inflammatory or progressively fibrotic conditions (e.g. rheumatoid
   arthritis, systemic lupus erythematosis, vasculitic disorders, idiopathic pulmonary
   fibrosis, retroperitoneal fibrosis).

23. Patients with any untreated stenosis > 70% of the distal aorta, common iliac, or
   external iliac arteries by CT, Angiography or MRI imaging will be excluded from
   enrollment (patients with previously successfully revascularized inflow stenoses may
   enroll in PACE). Subjects who were screen failures for a flow-limiting proximal lesion
   may be rescreened 3 months after successful angioplasty/stenting.

24. Inability to provide written informed consent due to cognitive or language barriers
   (interpreter permitted)

25. Concurrent enrollment in another clinical interventional investigative trial.

26. Presence of any clinical condition that in the opinion of the principal Investigator
   or the sponsor makes the patient not suitable to participate in the trial

Ages Eligible for Study

40 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Fouzia Khan
650-736-1410
Recruiting