non-healing ischemic hindlimb wound Critical Limb Ischemia
Conditions
Interventions
Drawing peripheral blood as material for cell processing product (Ricacell) and blood for various clinical tests.
Administration of cell processing product (Ricacell) subcutaneously or intramuscularl
Sponsors
Matsubara Shinobu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with written informed consent. 2. Patients are at the age of 20 to 75 at the time of informed consent. 3. Patients with Atherosclerotic PAD with >70% luminal stenosis in the leg arteries by digital subtraction angiography. 4. Patients who developed chronic hindlimb ischemia more than three months ago before having informed consent. 5. Patients of Rutherford classification, category 5. 6. Patients without adaptation for transluminal angioplasty or stenting and bypath surgery.
Exclusion criteria
Exclusion criteria: 1. Patients of Rutherford classification, category 6. 2. Patients with wound on heel. 3. Patients with Buerger's disease. 4. Patients with treatments of angioplasty, bypath surgery or LDL-apheresis for expecting leg for cell transplantation within a month. 5. Patients with HbA1c more than 8.0 with the medication for diabetes. 6. Patients with severe systemic infection. 7. Patients with severe anemia. 8. Patients with major amputation of another leg. 9. Patients with NYHA3 or 4, or Left ventricular ejection fraction< 25%. 10. Patients who have treatment with anti-angiogenic medicine for proliferative diabetic retinopathy and other disease. 11. Patients have malignancy, or within 5 years after recover from malignant tumor (10 years after breast cancer), except for cutaneous basal cell carcinoma. 12. Patients with hematopoietic disorders such as leukemia, myeloproliferative disease, marrow dysplasia syndrome. 13. Pregnant women, lactating women, female patients who may be pregnant, and who plan the pregnancy by the end of the observation period. 14. Patients infected with HIV, active HBV, HCV, HTLV, or syphilis in screening test. 15. Patients not expecting live for a year or more. 16. Patients enrolled in any other clinical trial within 90 days before informed consent. 17. Any other reason that the Clinical Researchers may have for considering a case unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of multiple dose injection of MNC-QQ cells side effects, adverse events, serious advese events, clinical laboratory data, vital sign, 12-lead electrocardiogram | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of multiple dose injection of MNC-QQ cells complete wound closure, wound size, Rutherford classification, WIfI classification, hindlimb physiological function test, VAS, major or minor amputation | — |
Countries
Japan
Contacts
Public ContactChiemi Tanaka
Juntendo University
Outcome results
None listed