Table 1.
List of clinical trials using NPC/NSC in adult subjects.
| Disease | Title | Trial phase | N° patients | Age | Follow-up (months) | Cell type | Site and mode of administration | Sponsor | NCT Number | Status |
|---|---|---|---|---|---|---|---|---|---|---|
| Age-Related Macular Degeneration | Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Age-Related Macular Degeneration (AMD) | Phase 1 Phase 2 |
15 | >50 | 12 | Human neural stem cell | Subretinal space (injection) | StemCells, Inc. | NCT01632527 | Completed |
| Amyotrophic Lateral Sclerosis | Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (hNSCALS) | Phase 1 | 18 | 20–75 | 36 | Human fetal neural stem cell | Lumbar spinal cord (surgical device) | Azienda Ospedaliera Santa Maria, Terni, Italy | NCT01640067 | Completed |
| Amyotrophic Lateral Sclerosis | CNS10-NPC-GDNF for the Treatment of ALS | Phase 1 | 18 | >18 | 12 | Human neural stem cell | Lumbar spinal cord (stereotactic device) | Cedars-Sinai Medical Center | NCT02943850 | Active, not recruiting |
| Amyotrophic Lateral Sclerosis | Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis | Phase 2 | 18 | >18 | 24 | Human neural stem cell | Spinal cord (injection) | Neuralstem Inc. | NCT01730716 | Unknown status |
| Amyotrophic Lateral Sclerosis | Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Phase 1 | 18 | >18 | 48 | Human neural stem cell | Lumbar spinal cord (surgical implant) | Neuralstem Inc. | NCT01348451 | Unknown status |
| Brain Tumors | Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients with Recurrent High-Grade Gliomas | Phase 1 | 18 | >18 | always | Human neural stem cell | Intracranial | City of Hope Medical Center | NCT02015819 | Active, not recruiting |
| Brain Tumors | A Pilot Feasibility Study of Oral 5-Fluorocytosine and Genetically-Modified Neural Stem Cells Expressing E. coli Cytosine Deaminase for Treatment of Recurrent High Grade Gliomas | Phase 1 | 15 | >13 | always | Human neural stem cell | Debulking craniotomy | City of Hope Medical Center | NCT01172964 | Completed |
| Brain Tumors | Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma | Phase 1 | 36 | >18 | NA | Induced neural stem cells | Intracranially | Northwestern University | NCT03072134 | Recruiting |
| Brain Tumors | Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients with Recurrent High-Grade Gliomas | Phase 1 | 53 | 18–69 | 180 | Human neural stem cell | Intracranial | City of Hope Medical Center | NCT02192359 | Recruiting |
| Ischemic Stroke | Pilot Investigation of Stem Cells in Stroke Phase II Efficacy (PISCES-II) | Phase 2 | 23 | >40 | 12 | Human neural stem cell | Intracerebral | ReNeuron Limited | NCT02117635 | Completed |
| Ischemic Stroke | Intracerebral Transplantation of Neural Stem Cells for the Treatment of Ischemic Stroke | Phase 1 | 18 | 30–65 | 24 | Human neural stem cell | Intracranial injection | Suzhou Neuralstem Biopharmaceuticals | NCT03296618 | Active, not recruiting |
| Ischemic Stroke | Investigation of Neural Stem Cells in Ischemic Stroke (PISCES III) | Phase 2 | 110 | 35–75 | 12 | Human neural stem cell | Stereotactic injection | ReNeuron Limited | NCT03629275 | Recruiting |
| Ischemic Stroke | A Clinical Study of iNSC Intervent Cerebral Hemorrhagic Stroke | Early Phase 1 | 12 | 30–65 | 12 | Induced neural stem cells | Intracerebral Transplantation | Allife Medical Science and Technology Co., Ltd. | NCT03725865 | Not yet recruiting |
| Parkinson's Disease | A Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient (hNSCPD) | Phase 2 Phase 3 |
12 | 35–70 | 6 | Human fetal stem cell | Nasal injection | Second Affiliated Hospital of Soochow University | NCT03128450 | Unknown status |
| Parkinson's Disease | A Study to Evaluate the Safety of Neural Stem Cells in Patients with Parkinson's Disease | Phase 1 | 12 | 30–70 | 12 | Induced neural stem cells | Intracerebrally to the striatum and substantia nigra | Cyto Therapeutics Pty Limited | NCT02452723 | Active, not recruiting |
| Parkinson's Disease | A Study on the Treatment of Parkinson's Disease with Autologous Neural Stem Cells | Early Phase 1 | 10 | 18–60 | 12 | Induced neural stem cells | NA | Allife Medical Science and Technology Co., Ltd | NCT03815071 | Not yet recruiting |
| Parkinson's Disease | Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease | Phase 1 Phase 2 |
12 | 35–85 | 6 | Human neural stem cell | Basal ganglia | NeuroGeneration | NCT03309514 | Not yet recruiting |
| Parkinson's Disease | Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease | Phase 1 Phase 2 |
50 | 50–80 | 12 | Human embryonic stem cell-derived neural precursor cells | Intra-striatal injection | Chinese Academy of Sciences | NCT03119636 | Recruiting |
| Pelizaeus-Merzbacher Disease (PMD) | Long-Term Follow-Up Study of Human Stem Cells Transplanted in Subjects with Connatal Pelizaeus-Merzbacher Disease (PMD) | Phase 1 | 4 | Child, Adult, Older Adult | 4 | Human neural stem cell | Brain | StemCells, Inc. | NCT01391637 | Completed |
| Peripheral Arterial Disease | Safety Trial of CTX Cells In Patients With Lower Limb Ischemia | Phase 1 | 5 | >50 | 12 | Human neural stem cell | Gastrocnemius muscle | ReNeuron Limited | NCT01916369 | Completed |
| Progressive Multiple Sclerosis | Neural Stem Cell Transplantation in Multiple Sclerosis Patients (STEMS) | Phase 1 | 12 | 18–55 | 24 | Human fetal-derived Neural Stem Cells | Intrathecal | IRCCS San Raffaele | NCT03269071 | Enrolling by invitation |
| Secondary Progressive Multiple Sclerosis | Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients (NSC-SPMS) | Phase 1 | 24 | 18–60 | 12 | Human neural stem cell | Intraventricular | Casa Sollievo della Sofferenza IRCCS | NCT03282760 | Active, not recruiting |
| Spinal Cord Injury | NeuroRegen Scaffold, Combined with Stem Cells for Chronic Spinal Cord Injury Repair | Phase 1 Phase 2 |
30 | 18–65 | 24 | Human neural stem cell | Spinal cord (injection) | Chinese Academy of Sciences | NCT02688049 | Enrolling by invitation |
| Spinal Cord Injury | Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects | NA | 12 | 18–65 | NA | Human neural stem cell | Intramedullary spinal cord transplantation | StemCells, Inc. | NCT01725880 | Terminated |
| Spinal Cord Injury | Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI (SCI) | Phase 1 | 8 | 18–65 | 54 | Human neural stem cell, spinal cord derived | N/A | Neuralstem Inc. | NCT01772810 | Recruiting |
| Spinal Cord Injury | Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients with Thoracic Spinal Cord Injury | Phase 1 Phase 2 |
12 | 18–60 | 48 | Human neural stem cell | Intramedullary transplantation | StemCells, Inc. | NCT01321333 | Completed |