Side Effects of 4 Times Bone Marrow Mono Nuclear Transplantation in Patients With Ischemic Lower Limb
Condition: Ischemic Ulcer
MeSH terms: Ischemia; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb
      perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic
      needs of the tissue, even under resting conditions. The limits of peripheral artery disease
      (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have
      been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults
      older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of
      collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the
      pathophysiology of vascular disease. By stimulating these processes the investigators might
      be able to provide an alternative treatment strategy for patients with lower limb ischemia.
      In response to tissue injury and remodeling, neovascularization usually occurs via the
      proliferation and migration of progenitor endothelial cells (EPC) from preexisting
      vasculature. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC)
      implantation increases collateral vessel formation in patients with limb ischemia. So the
      investigators determine to evaluate the efficacy of repeated MNC transplantation in patients
      with ischemic lower limb.
    

Detailed description: 
      In this study we transparent bone marrow derived mononuclear stem cells 4 times to the
      ischemic limb of 11 patients with PAD.first of all all the patients evaluate by physical
      examination,PFWD,ABI and serologic tests.then underwent bone marrow aspiration to take
      sample.In our lab the MNC are separated and divided in to equal doses.one of them inject to
      the ischemic foot and the othr one are freezed and inject after 3weeks.3 weeks after second
      injection again patient underwent bone marrow aspiration and the same process repeat.then
      after 4times transplantation,patients are followed up after 1,3,6,9,12 months after injection
      and evaluate by physical examination,PFWD,ABI and serologic tests.all the data are collected
      and analysed and the result will be shown.3 patients underwent cell transplantation just one
      time due to one time bone marrow aspiration.They are followed up after 1,3,6,9,12 months
      after injection and evaluate by physical examination,PFWD,ABI and serologic tests.at the end
      of the study patients with 4imes injection and 1time injection will be compared.
    

Intervention name(s): 4times injection; stem cell transplantation
Intervention type(s): Biological; Biological
Intervention description(s): bone marrow derived mono nuclear stem cell; Mono nuclear stem cell transplantation by intra muscular injection to the ischemic lower limb
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone marrow mono nuclear stem cell ischemic ulcer