Revascularization by Peripheral B lood Mononuclear Cell Transplant atio

Phase 1

• Conditions: Critical limb ischemia due to peri pheral artery disease (critical limb ischemia) and Buerger's dise

• Registration Number: JPRN-jRCTb070190061
• Lead Sponsor: Kenichi Tsujita

Brief Summary

Follow-up of five ptinets treated with PBMC were completed.However, this study was early terminated because of smaller number of enrolled patients than initially planed.The enough data were obtained for priary and secondary outcomes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-31
• Study Completion: 2021-01-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1) Patients with critical limb ischemia caused by peripheral artery disease or Burger's disease. 2) over 20 years old 3) patient who can take a informed consent.

Exclusion Criteria

1)Patients who have severe hypersensitivity or history of side effects to aphaeresis. 2)Patients who have malignant tumor or history of malignancy with in the past 3 years. 3)Patients who have experienced acute myocardial infarction, unstable angina pectoris, myocarditis or cerebral infarction within 3 months. 4)Patients with active infection. 5)Patients who are pregnant or might be pregnant. 6)Patients with proliferative diabetic retinopathy (untreated, medium-term and late proliferative retinopathy) the end of treatment example is excluded. 7)Patients with platelets less than 70,000 platelets in blood test just before apheresis. 8)Patients with less than serum albumin 2 mg/dL. 9)Patients who are judged inappropriate for this trial by their attending physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified