TABLE 2.
Key completed clinical trials of cell therapies for spinal cord injury
| Cell type | Sponsor; country | Phase; Clinicaltrials.gov identifier | # Participants; age | Injury level; severity; transplant interval after SCI | Route of cell delivery | Completion date |
|---|---|---|---|---|---|---|
| Autologous BMSC | Puerta de Hierro University Hospital, Spain | Phase II; NCT02570932 | 10; 18‐70 yr | ASIA A‐D; more than 6 mo | Intrathecal; 3 injections 3 mo apart | Dec 2017 |
| Autologous BMSC | Indian Spinal Injuries Centre, India | Phase I/II; NCT02260713 | 21; 18‐50 yr | T1‐T12; ASIA A; 10‐14 days | Intrathecal (single injection) or intraspinal | Nov 2017 77 |
| Autologous BMSC | Hospital Sao Rafael, Brazil | Phase I; NCT01325103 | 14; 18‐50 yr | Thoracic and lumbar; ASIA A; more than 6 mo | Intraspinal | Dec 2012 78 |
| Autologous BMSC | International Stemcell Services Limited, India | Phase I; NCT01186679 | 12; 20‐55 yr | C4‐T12; ASIA A‐C; acute within 2 wk, subacute 2‐8 wk, chronic more than 6 mo | Intrathecal for acute and subacute; intraspinal for chronic | Aug 2010 |
| Autologous BMSC | Cairo University, Egypt | Phase I/II; NCT00816803 | 80; 10‐36 yr | C3‐T12; ASIA A‐B; 10 mo to 3 yr | Intrathecal | Dec 2008 79 |
| Autologous MSC | Hospital Sao Rafael, Brazil | Phase I; NCT02152657 | 5; 18‐65 yr | T8 and below; ASIA A; more than 6 mo | Percutaneous injection | Dec 2016 |
| Autologous Adipose‐derived MSC | Biostar, Korea University Anam Hospital, Korea | Phase I/II; NCT01769872 | 15; 19‐70 yr | ASIA A‐C; more than 3 mo | Intravenous, intrathecal, and intraspinal; each single injections | Jan 2016 80 |
| Autologous Adipose‐derived MSC | Biostar, Anyang Sam Hospital, Korea | Phase I; NCT01274975 | 8; 19‐60 yr | ASIA A‐C; more than 2 mo | Intravenous, single injection | Feb 2010 81 |
| Autologous BMSC vs Adipose‐derived MSC | University of Jordan, Jordan | Phase I/II; NCT02981576 | 14; 18‐70 yr | AISA A‐C; more than 2 wk | Intrathecal; total of three injections | Jan 2019 |
| Autologous BM‐MNC | Armed Forces Bone Marrow Transplant Center, Pakistan | Phase I; NCT02482194 | 9; 18‐50 yr | Thoracic; ASIA A; more than 2 wk | Intrathecal | Mar 2016 82 |
| Autologous BM‐MNC | Neurogen Brain and Spine Institute, India | Phase I; NCT02027246 | 166; 8 mo to 63 yr | Any SCI | Intrathecal | Feb 2013 |
| Autologous BM‐MNC | China Spinal Cord Injury Network, China | Phase I/II; NCT01354483 | 20; 18‐60 yr | C5‐T11; ASIA A; more than 1 yr | Intraspinal; dose escalation | Dec 2013 |
| Human Central Nervous System Stem Cells (HuCNS‐SC) | StemCells, Inc, Canada and Switzerland | Phase I/II; NCT01321333 | 12; 18‐60 yr | T2‐T11; ASIA A‐C; 3‐12 mo | Intraspinal | Apr 2015 83 |
| Human Central Nervous System Stem Cells (HuCNS‐SC) | StemCells, Inc, Canada and United States | Phase II; NCT02163876; terminated (based on a business decision unrelated to any safety concerns) | 31; 18‐60 yr | C5‐C7; ASIA B‐C; more than 12 wk | Intraspinal | May 2016 |
| ESC‐derived OPC (GRNOPC1) | Asterias Biotherapeutics, Inc, United States | Phase 1; NCT01217008 | 5; 18‐65 yr | T3‐T11; ASIA A; 1‐2 wk | Intraspinal | July 2013 |
| ESC‐derived OPC (AST‐OPC1) | Asterias Biotherapeutics, Inc, United States | Phase I/IIa; NCT02302157; | 25; 18‐69 yr | C4‐7; ASIA A‐B; 21‐42 days | Intraspinal; dose escalation study | Dec 2018 |
| Autologous Human Schwann Cells (ahSC) | The Miami Project to Cure Paralysis, University of Miami, United States | Phase I; NCT01739023 | 9; 18‐60 yr | T3‐T11; ISNCSCI grade A; 30‐72 days | Intraspinal | Aug 2016 50 |
| Autologous Human Schwann Cells (ahSC) | The Miami Project to Cure Paralysis, University of Miami, United States | Phase I; NCT02354625; recruiting | 8; 18‐65 yr | C5‐T12; ASIA A‐C; more than 12 mo | Intraspinal | Aug 2019 |
Note: Clinical trials that are completed are identified with the NCT number listed on www.ClinicalTrials.gov. Published results of clinical trials, if available, are referenced.
Abbreviations: BM‐MNC, bone marrow‐derived mononuclear cells; BMSC, bone marrow‐derived mesenchymal stem cells; ESC, embryonic stem cell; ISNCSCI, International Standards for Neurological Classification of Spinal Cord Injury; MSC, mesenchymal stem cells; NSPC, neural stem/progenitor cells; OPC, oligodendrocyte precursor cells.