Ischemia Clinical Trial
Official title:
Phase I / II Clinical Trial Regarding Vascular Regeneration Therapy by Transplantation of Autologous Peripheral Blood Endothelial Progenitor Cells (CD34+ Cells) in No-Option Patients With Chronic Critical Limb Ischemia
The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.
Status | Completed |
Enrollment | 15 |
Est. completion date | January 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Chronic severe CLI patients fulfilling all the following criteria are considered suitable for inclusion in the study. 1. At least 6 months since the onset of CLI (Chronic peripheral artery disease or Buerger disease) 2. Patients with luminal stenosis > 50% by leg angiography 3. Age is between 20 and 80. 4. Patients whose Rutherford's class is II-4, III-5, or III-6(Patients with rest pain or ischemic ulcer/necrosis) 5. Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/ restenosis following the traditional revascularization (No option patients) 6. Patients who can give informed consent themselves in writing. Exclusion Criteria: - Any one of the following exclusion criteria is sufficient to disqualify a patient from the study. 1. Left ventricular ejection fraction < 25% 2. Patients with a history of severe allergic reactions or side effects to G-CSF preparations or apheresis. 3. Less than 6 months since last episode of myocardial/cerebral infarction. 4. Patients with unstable angina, with a treatment rating of 3 in the Braunwald system, but a severity of III and a clinical rating of B or C. 5. Patients with diabetic proliferating retinopathy (new Fukuda classification BI to BV). 6. Patients with malignant tumor 7. Patients with chronic rheumatoid arthritis. 8. Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes). 9. Patients currently suffering from or having a history of interstitial pneumonitis. 10. Patients for whom cranial MRA reveals cerebral aneurysm. 11. Patients for whom abdominal CT or ultrasonography reveals splenomegaly. 12. Patients with cirrhosis of the liver. 13. Patients who cannot discontinue Warfarin. 14. Leukocytes less than 4,000/µL or exceeding 10,000/µL. 15. Platelets less than 100,000/µL. 16. Hemoglobin less than 10 g/dL. 17. AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L. 18. Patients with severe neural disorder in their legs. 19. Patients with gait disturbance for reasons other than CLI (such as sciatic neuralgia, or vasculitis), making exercise tolerance evaluation on a treadmill with stress ECG difficult. 20. Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period. 21. Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Institute of Biomedical Research and Innovation | Kobe | Hyogo |
Japan | Kobe City General Hospital | Kobe | Hyogo |
Lead Sponsor | Collaborator |
---|---|
Translational Research Informatics Center, Kobe, Hyogo, Japan | Institute of Biomedical Research and Innovation, Kobe,Hyogo, Japan, Kobe City General Hospital |
Japan,
Asahara T, Kawamoto A. Endothelial progenitor cells for postnatal vasculogenesis. Am J Physiol Cell Physiol. 2004 Sep;287(3):C572-9. Review. — View Citation
Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. — View Citation
Kalka C, Masuda H, Takahashi T, Kalka-Moll WM, Silver M, Kearney M, Li T, Isner JM, Asahara T. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3422-7. — View Citation
Kawamoto A, Gwon HC, Iwaguro H, Yamaguchi JI, Uchida S, Masuda H, Silver M, Ma H, Kearney M, Isner JM, Asahara T. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation. 2001 Feb 6;103(5):634-7. — View Citation
Kawamoto A, Tkebuchava T, Yamaguchi J, Nishimura H, Yoon YS, Milliken C, Uchida S, Masuo O, Iwaguro H, Ma H, Hanley A, Silver M, Kearney M, Losordo DW, Isner JM, Asahara T. Intramyocardial transplantation of autologous endothelial progenitor cells for therapeutic neovascularization of myocardial ischemia. Circulation. 2003 Jan 28;107(3):461-8. — View Citation
Takahashi T, Kalka C, Masuda H, Chen D, Silver M, Kearney M, Magner M, Isner JM, Asahara T. Ischemia- and cytokine-induced mobilization of bone marrow-derived endothelial progenitor cells for neovascularization. Nat Med. 1999 Apr;5(4):434-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major amputation | |||
Secondary | Limb ischemia |
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