Review Article

A Molecular and Clinical Review of Stem Cell Therapy in Critical Limb Ischemia

Table 1

Clinical trials using stem cells for treatment of peripheral artery disease related critical limb ischemia.

Trial numberPhaseStudy periodRouteTreatment

NCT008838701 and 24/2009–3/2011IMEx vivo cultured adult allogeneic MSCs versus plasmalyte A
NCT006169801 and 212/2007–10/2010IMAutologous CD34+ cells
NCT00919958106/2009–06/2010IMAllogeneic PLX-PAD
NCT00951210108/2009–10/2011IMAllogeneic PLX-PAD
NCT010499191 and 206/2010–05/2014IMAutologous concentrated BM aspirate using MarroStim PAD kit
NCT00468000204/2007–03/2011IMAutologous BM cells
NCT009873631 and 207/2009–12/2011IAAutologous BM-derived MNCs
NCT01019681111/2009–11/2015IMUmbilical cord blood stem cells
NCT008723261 and 212/2007–05/2009IAAutologous BM-derived MNCs
NCT00523731101/2006–03/2007IMAutologous, nonmobilized angiogenic cell precursor
NCT003925091 and 210/2006–12/2008IMAldehyde dehydrogenase bright stem and progenitor cells
NCT010794031 and 212/2009–12/2011IAAutologous adipose tissue-derived MSCs
NCT004980691 and 211/2007–12/2014IMAutologous BM aspirate
NCT009223891 and 207/2009–01/2011IMG-CSF+ PB-derived MNCs
NCT00913900105/2009–09/2012IMAutologous CD133+ cells
NCT003713711 and 211/2006–07/2013IAAutologous BM-derived MNCs
NCT00721006211/2006–12/2010SC (40x)Combination of SCT
NCT01065337210/2004–02/2009IM/IAAutologous BM-derived MNCs versus tissue repair cell CD90+ cells
NCT005331041 and 210/2004–02/2009IM (30x)Autologous PB-derived MNCs and BM-derived MNCs
NCT005952571 and 212/2007–08/2010IMAutologous BM aspirate using SmartPREP2
NCT004346162 and 304/2007–07/2011IMAutologous BM cell concentrate
NCT00904501303/2009–06/2014IMAutologous BM-derived MNCs
NCT00488020104/2006–06/2007IM (40x)Autologous BM-derived MNCs
NCT00518401106/2007–10/2009IM (40x)Combination of stem cell mixture
NCT002211431 and 211/2003–01/2008IM (40x)Autologous PB CD34+ cells
NCT005392662 and 310/2007–10/2010IMAutologous BM-derived MNCs (DM versus non-DM)
NCT00145262208/2003–IMAutologous BM-derived MNCs
NCT002826461 and 210/2005–03/2011IAAutologous BM-derived MNCs
NCT02538978308/2015–07/2016IMAutologous BM cells using SurgWerksTM-CLI kit and VXPTM system
NCT01386216106/2011–01/2017IMAutologous BM aspirate using Magellan system
NCT015589081 and 203/2012–IMEndometrial regenerative cells
NCT02551679211/2015–IMAutologous angiogenic cell precursors
NCT02140931205/2014–11/2015IMAutologous angiogenic cell precursors

BM: bone marrow; BM-MNC: bone marrow mononuclear cell; DM: diabetes mellitus; G-CSF: granulocyte colony-stimulating factor; IA: intra-arterial; IM: intramuscular; MSC: mesenchymal stem cell; PAD: peripheral arterial disease; PB: peripheral blood; PB-MNC: peripheral blood mononuclear cell; PLX-PAD: placental-derived mesenchymal stem cells; SC: subcutaneous.