Table 2.
Clinical Trials of Cell Therapy for SCI Listed on www.clinicaltrials.gov
| Status | Study | NCT | Cells | Administration route | Phase | Country | Sponsor/Investigator | Duration | Numbers enrolled |
|---|---|---|---|---|---|---|---|---|---|
| Recruiting | Transfer of bone marrow-derived stem cells for the treatment of SCI | NCT 01162915 | Autologous BMSCs, expanded ex vivo | Intrathecal infusion, single dose | I, single centre | USA | TCA Cellular Therapy, LLC; Gabriel P. Lasala | July 2010-June 2012 | 10 |
| Completed | Cell transplant in SCI patients | NCT 00816803 | Autologous bone marrow | ? | I/II | Egypt | Cairo University, Cancer Institute of New Jersey, UMDNJ/RWJMS; Hatem E. Sabaawy | May 2005-Dec 2008 | 80 |
| Condition: Chronic SCI | |||||||||
| Procedure: physical therapy | |||||||||
| Recruiting | Transplantation of autologous OECs in complete human SCI | NCT 01231893 | Autologous olfactory mucosa ensheathing cells (OECs) and fibroblasts | Intra-spinal | I | Poland | Wroclaw Medical University; Wlodzimierz Jarmundowicz, Pawel Tabakow | May 2008 | 10 |
| Other: rehabilitation | |||||||||
| Terminated | Treatment for acute SCI | NCT 00695149 | BMSC | Into cerebrospinal fluid | I/II | Japan | Translational Research Informatics Center | July 2005-Mar 2010 | 23 |
| Completed | Autologous adipose-derived MSCs transplantation in patients with SCI | NCT 01274975 | Autologous adipose-derived MSCs | Intravenous infusion, 4 × 108 cells | I | Korea | RNL Bio Company Ltd, SangHan Kim | July 2009-Feb 2010 | 8 |
| Recruiting | Safety and feasibility of umbilical cord blood cell transplant into injured spinal cord Drug: +/− methylprednisolone drug: +/− lithium | NCT 01046786 | Umbilical cord blood mononuclear cell, dose comparison | Intra-spinal | I/II | China | China Spinal Cord Injury Network | Jan 2010-June 2012 | 20 |
| Completed | Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating SCI Condition: Acute, subacute and chronic SCI Procedure: laminectomy | NCT 01186679 | Autologous bone marrow | Intrathecal | I/II | India | International Stemcell Services Limited, Arvind Bhateja | Jan 2008-Aug 2010 | 12 |
| Enrolling by invitation | Umbilical cord blood mononuclear cell transplant to treat chronic SCI | NCT 01354483 | HLA-matched umbilical cord blood mononuclear cells | I/II | China | Treating Center of Spinal Cord Injury Chengdu Army Kunming General Hospital (Dr Hui Zhu ) | Sep 2010-Dec 2012 | 20 | |
| Other : methylprednisolone, sodium succinate or lithium carbonate plus rehabilitation | |||||||||
| Suspended | Autologous incubated macrophages for patients with complete SCIs condition: Acute SCI | NCT 00073853 | Autologous incubated macrophages | Intra-spinal | II | USA, Israel | Proneuron Biotechnologies, Marcus Foundation | Sep 2003 | 61 |
| B.I.R.D. (Israel-U.S. Binational Industrial Research and Development); Daniel Lammertse, Nachshon Knoller, Marca Sipski, Edward Benzel | |||||||||
| Recruiting | Safety study of GRNOPC1 in SCI | NCT 01217008 | GRNOPC1 (ES cell-derived oligodendrocytic progenitors) | Intra-spinal, single dose of 2 million cells | I | USA | Geron, Gary K. Steinberg, David Apple, Richard G Fessler, James S Harrop, Shekar Kurpad | Oct2010-Oct 2012 | 10 |
| Condition: Complete T3-T9 level sub-acute (7–14 days post-injury) SCI | |||||||||
| Recruiting | Autologous stem cells for SCI in children | NCT 01328860 | Autologous | Intravenous infusion | I | USA | Memorial Hermann Healthcare System, James E. Baumgartner | Apr 2011-Oct 2014 | 10 |
| Condition: Primary SCI, to minimize secondary SCI | BMSCs | ||||||||
| Recruiting | Autologous bone marrow stem cell transplantation in patients with SCI | NCT 01325103 | Autologous BMSC | Intra-spinal | I | Brazil | Hospital Sao Rafael; Ricardo R. dos Santos | July 2010-Jan 2013 | 20 |
| Recruiting | Study of human CNS stem cells (HuCNS-SC) in patients with thoracic SCI Condition: subacute thoracic (T2-T11) SCI | NCT 01321333 | HuCNS-SC cells | Single dose, intramedullary | I/II | Switzerland | StemCells, Inc.; Armin Curt | Mar 2011-Mar 2016 | 12 |
Phase I trials are generally small studies to ensure that the new drug or procedure is safe and well tolerated. Phase II trials are to test efficacy in a small group of well defined, treated and control patients. Phase III trials are large multi-centre studies to test the efficacy and safety of the treatment in a large number of patients as a prelude to introducing the drug or procedure to clinical practice.
BMSCs = bone marrow mesenchymal/stromal cells; CNS = cerebrospinal fluid; ES = embryonic stem cell; HLA = human leukocyte antigen; HuCNS-SC cells = xxxxxxx cells; MSCs = xxxx; NCT = xxxxxx; OECs = olfactory ensheathing cells; SCI = spinal cord injury;