ArticleBMJ open2022
Efficacy and safety of human-derived neural stem cell in patients with ischaemic stroke: study protocol for a randomised controlled trial.
Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.
- Intranasal administration of stem cells and their derivatives for neurological and respiratory disorders: a systematic review of human clinical trials.Frontiers in aging neuroscience · 2026Pooled it
- Intranasal human-recombinant NGF administration improves outcome in children with post-traumatic unresponsive wakefulness syndrome.Biology direct · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionStroke is the most common cause of neurological disability in adults worldwide. Neural stem cell (NSC) transplantation has shown promising results as a treatment for stroke in animal experiments. The pilot investigation of stem cells in stroke phase 1 and phase 2 trials showed that transplantation of the highest dose (20 million cells) was well tolerated. Preliminary clinical benefits have also been observed. However, the trials were open-label and had a small sample size. Furthermore, human NSCs (hNSCs) were intracerebrally implanted, and some serious adverse events were considered to be related to the surgical procedure. Therefore, we plan to conduct a double-blinded, randomised controlled trial to test the safety and efficacy of intranasal injection of hNSCs. METHODS AND ANALYSIS: This single-centre, randomised, double-blinded, parallel-controlled trial will be conducted in China. Sixty patients with ischaemic stroke who met the qualification criteria will be randomly divided into two groups: the NSCs and control groups. All participants will receive intranasal administration of hNSCs or placebo for 4 consecutive weeks. Patients will be followed up at baseline and at 4, 12, 24 and 48 weeks after intervention. The primary outcome is the National Institutes of Health Stroke Scale score (4, 12, 24 weeks after intervention). Secondary outcomes include the modified Rankin scale, Barthel index, Mini-Mental State Examination score (4, 12, 24 weeks after intervention) and cranial MRI changes (24 and 48 weeks after intervention). All adverse events will be recorded during the study period. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of Ren Ji Hospital (2018-009). All subjects will provide informed consent. The results will be accessible in peer-reviewed publications and will be presented at academic conferences.
trial registrationChiCTR1900022741; Chinese Clinical Trial Registry.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.