Randomized controlled trial of G-CSF-mobilized peripheral blood mononuclear cells transplantation for the treatment of patients with Peripheral Arterial Disease

UMIN ID: UMIN000002280

Registered date:01/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Peripheral Arterial Disease (arteriosclerosis obliterans, buerger's disease)
• Date of first enrollment: 2009/08/01
• Target sample size: 144
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Recommended treatment group The recommended therapy is performed based on TASC2 and 'Guideline 2 diagnosis and treatment for inferior ASO' edited by Japanese college of angiology.
Recommended treatment and Cells transplantation group

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: 1) Changes of Fontaine classification or Rutherford classification 2) Overall survival 3) Time-to-amputation 4) Amputation-free survival 5) Ulcer /Gangrene size 6) Severity of ischemic pain in lower limbs 7) ABI (TBI in measurable patients) 8) ICD and ACD

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients with severity progression of Fontaine classification or Rutherford classification within 1 month 2) Major amputation of lower limb is planned 3) Patients who performed angioplasty, bypass surgery, other surgical therapy or LDL apheresis within 1 month. 4) Patients who have serious allergic reaction or adverse reaction to G-CSF or apheresis 5) Patients with uncontrolled ischemic heart disease, heart failure or arrhythmia 6) Patients with severe stenotic lesion at major artery in intracranial or extracranial 7) Less than 6 months since last episode of myocardial/brain infarction, brain hemorrhage or TIAs. 8) Dialysis patients of Fontaine4, who have a history of ischemic heart disease, brain infarction or brain hemorrhage. 9) Patients with diabetic proliferating retinopathy (new Fukuda classification BI to BV). 10) Patients with malignant tumor within 3 years 11) Leukocytes less than 4,000/µL or exceeding 10,000/µL., platelets less than 50,000/µL, AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L 12) Patients who have coexisting or history of interstitial pneumonia, or take the medicine with possibility of causing interstitial pneumonia 13) Patients who complicated by infection with fever over 38C 14) Patients with splenomegaly 15) Patients with claudication symptom, rest pain, ulcer or gangrene unrelated to primary disease 16) Patients with severe neuropathy in the lower limbs, and be difficult to evaluate in this trial 17) Patients with uncontrollable mental disorders 18) Patients with coexisting or history of hyperfunction of thyroid gland 19) Patient who is within 6 months from the end of other trails 20) The females who are in pregnancy or lactation, may be pregnant, or are planning to become pregnant before the end of trial period. The males who desire pregnancy of partner.

Related Information

• Primary Sponsor: Japan Study group of peripheral vascular regeneration cell therapy
• Source(s) of Monetary Support: Resarch Foundation for Community Medicine
• Secondary ID(s): TRIPAD0708