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Table 1 Eligibility criteria for patients enrolled in the study

From: A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia

• Inclusion criteria Exclusion criteria
• Males or females with non-child bearing potential in the age group of 18–60 yrs. of Indian origin. • Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure and patients with any acute/chronic inflammatory condition.
• Established CLI, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients). • CLI patient requiring amputation proximal to trans-metatarsal level.
• Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 70 mm Hg or TcPO2 ≤ 60 mmHg in the foot. • Patients with gait disturbance for reasons other than CLI.
• Patients if having associated Type II Diabetes should be on medication and well controlled (HbA1c ≤ 8%) without complications. • Type I diabetes.
  • Patients having respiratory complications/left ventricular ejection fraction < 25% Stroke or myocardial infarction within last 3 months.
  • Patients who are contraindicated for MRA