Transplantation of autologous mononuclear cells in patients with critical limb ischemia (CLI) - MNC therapy in CLI patients

Regenerative Medicine Unit, Division of Vascular Regeneration Therapy, Institute of Biomedical Research and Innovation (IBRI)0 sites5 target enrollmentMarch 10, 2011

ConditionsCLI (atherosclerotic PAD/Buerger disease)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: CLI (atherosclerotic PAD/Buerger disease)
Sponsor: Regenerative Medicine Unit, Division of Vascular Regeneration Therapy, Institute of Biomedical Research and Innovation (IBRI)
Enrollment: 5
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 10, 2011

End Date

December 19, 2013

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Regenerative Medicine Unit, Division of Vascular Regeneration Therapy, Institute of Biomedical Research and Innovation (IBRI)

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\) CLI within category 6 on the Rutherford's scale 2\) Less than 3 months since success of bypass surgery, transluminal angioplasty and sympathectomy for the limb expected to be transplanted 3\) Left ventricular ejection fraction\< 25% 4\) Patients with a history of severe side effects to apheresis 5\) Patients with malignant tumor 6\) Patients with diabetic proliferating retinopathy (new Fukuda classification Bii to BV) 7\) Less than 3 months since last episode of unstable angina and myocardial/cerebral infarction 8\) Patients with cirrhosis of the liver 9\) Leukocytes exceeding 15,000/ micro L 10\) Platelets less than 100,000/ micro L 11\) Hemoglobin less than 8 g/dL 12\) Patients with rest pain, ulcer or necrosis for reasons other than CLI (such as lumber spinal canal stenosis, arthropathy or vasculitis) 13\) Patients who require major amputation regardless of whether revascularization is successful or not, because of exposure of the bone or tendon due to osteomyelitis, osteonecrosis, ulcer and soft tissue necrosis, or sepsis 14\) Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period 15\) Patients enrolled in any other clinical trial 16\) Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.