Table 2.
Clinical trials using neural stem cells for the treatment of stroke (active and recruiting)
| NCT number | Tittle | Status | Interventions | Study type | Outcome measure | Population | Sponsor | Process observed |
| NCT03296618 | Intracerebral transplantation of neural stem cells for the treatment of ischemic stroke | Active (completed) | NSI-566: A group: 1.2 × 107; B group: 2.4 × 107; C group: 7.2 × 107 | Interventional (one-time intra-cerebral injections) | AE & NIHSS & mRS, MMSE, FMMS | Enrollment: 9; age: 33–65 yr (150–743 d post-stroke) | Suzhou Neuralstem Biopharmaceuticals Neuralstem Inc. | NP; NG; MR; VR |
| NCT03725865 | A clinical study of iNSC intervent cerebral hemorrhagic stroke | Not yet recruiting | iNSCs | Interventional | Emergent AE | Enrollment:12; age: 30–65 yr; sex: both | Allife Medical Science and Technology Co. Ltd. | NP; NG; MR; VR |
| NCT01151124 | Pilot investigation of stem cells in stroke | Active (completed) | CTX0E03 (NSCs), single doses of 2 million, 5 million, 10 million, or 20 million cells | Intervention (stereotactic ipsilateral putamen injection) | AE & BI & MMSE, mRS, EQ-5D | Enrollment: 12; age: 60–85 yr (29 mon post-stroke); sex: male | ReNeuron Limited (Division of Clinical Neurosciences, Glasgow) | NP; NG; MR; VR |
| NCT03629275 | Investigation of neural stem cells in ischemic stroke | Recruiting | Combination product: CTX0E03 drug product and delivery device; Drug: placebo | Intervention | mRS at 6 mon BI; basic mobility changing and TUG, CAHAI & SDMT & COWAT & MNT & MCA | Enrollment: 110; Age: 35–75 yr (adult, older adult); aex: both | ReNeuron Limited (University of California, Irvine, CA, USA) | NP; NG; MR; BN; VR |
| NCT02854579 | Neural progenitor cell and paracrine factors to treat hypoxic ischemic encephalopathy | Active (completed) | Biological: NPC; Biological: paracrine factors; Biological: progenitor cell and paracrine factors | Interventional; intra-cerebral injections | Neonatal behavioral assessment; adverse events; Bayley score; Peabody development measure scale; MRI or CT | Enrollment:120; age: up to 14 d (child); sex: both | Navy General Hospital, Beijing, China | NP; NG; MR; BN; VR |
| NCT02117635 | Pilot investigation of stem cells in stroke phase II efficacy | Complete | Biological: CTX DP | Interventional | ARAT and after CTX; NIHSS; RFA & BI after CTX; Safety/ Tolerability; FMMS after CTX | Enrollment: 23; age: 40 yr older (adult, older adult); sex: both | ReNeuron Limited (Queen Elizabeth Hospital, Birmingham, UK) | NP; NG; MR; VR; |
| NCT04047563 | Efficacy of sovateltide (PMZ-1620) in patients of acute ischemic stroke | Recruiting | Drug: PMZ-1620 (sovateltide) along with standard treatment | Interventional, phase 3 | NIHSS/mRS; change in quality-of-life; change in Stroke-Specific Quality of Life | Enrollment: 110; age: 18–78 yr (adult, older adult); sex: both | Pharmazz, Inc. | NP; NG; MR; VR |
| NCT03005249 | Neural stem cells therapy for cerebral palsy | Recruiting | Biological: NSC | Interventional, intranasal administration | GMFM-88 score; Fine Motor Function Measure score; modified Ashworth Scale score; AEEG/ MRI/EMG | Enrollment: 20; age: 1–12 yr (child); cerebral palsy | The First Affiliated Hospital of Dalian Medical University, Dalian, China | NP; NG; MR; VR |
Information obtained from ClinicalTrials.gov on April 20, 2020. AE: Adverse events; AEEG: amplitude-integrated electroencephalography; ARAT: Action Research Arm Test; BI: Barthel Index; BN: brain networks; CAHAI: Chedoke Arm and Hand Activity Inventory; COWAT: Controlled Oral Word Association tasks (Language skills); CTX: CTX0E03, a human NSC line; DP: drug product; EMG: electromyography; EQ-5D: EuroQol-5D; FMMS: Fugl-Meyer Motor Score; GMFM-88: Gross Motor Function Measure-88; iNSC: induced NSC; MCA: Montreal Cognitive Assessment (Language skills); MMSE: Mini-mental State Examination; MNT: Multilingual Naming Test (Language skills); MR: myelin repair; mRS: modified Rankin Scale; NG: neurite growth; NIHSS: National Institutes of Health Stroke Scale; NP: neuron polarity; NPC: neural progenitor cell; NSCs: neural stem cells; RFA: Rankin Focused Assessment; SDMT: Symbol Digit Modalities Test (Language skills); TUG: Timed Up and Go Test; VR: vascular regeneration.