ArticleBMJ open2026
Clinical safety and preliminary efficacy of allogeneic human induced pluripotent stem cell-derived exosomes in patients with acute ischaemic stroke: protocol of a phase I/II clinical trial in China.
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06138210 (The Effect of Exosomes Derived From Human Induced Pluripotent Stem Cell), which is not on this map. Not yet cited in PubMed.
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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.
The Effect of Exosomes Derived From Human Induced Pluripotent Stem Cell (GD-iExo-003) in Acute Ischemic Stroke: an Exploratory Study.
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17 authors.
Funding
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Abstract
introductionCell-based therapies represent a promising therapeutic strategy for enhancing neurological recovery after stroke. Preclinical studies have demonstrated the efficacy of stem cell-derived exosomes in animal models of ischaemic stroke. We aim to evaluate the safety and preliminary efficacy of allogeneic human induced pluripotent stem cell (iPSC)-derived exosomes in patients with acute ischaemic stroke. METHODS AND ANALYSIS: This is a multicentre, prospective, phase I/II clinical trial conducted in China between October 2023 and June 2026. Eligible participants will be patients with a diagnosis of cortical ischaemic stroke, a baseline National Institutes of Health Stroke Scale (NIHSS) score of 6-20 and enrolment within 1-7 days after symptom onset. Stage 1 is a dose-escalation study including three different dose levels (n=3 per dose). Stage 2 is an expanded safety and preliminary efficacy phase with a randomised, double-blind, placebo-controlled design. In Stage 2, 20 patients will be randomised 1:1 to receive the highest safe dose identified in Stage 1 or placebo. The primary endpoint is the incidence of serious adverse events within 90 days. Secondary efficacy endpoints include the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days, ordinal mRS distribution at 90 days and changes in NIHSS and Barthel Index scores at 90 days, as well as EuroQol-5D-5L and Montreal Cognitive Assessment (MoCA) scores at 90 days. ETHICS AND DISSEMINATION: This protocol was written according to the general ethical guidelines of the Declaration of Helsinki and approved by the Ethics Committee of Xuanwu Hospital Capital Medical University (approval number [2023]161), the Third People's Hospital of Liaocheng, the First People's Hospital of Chenzhou, Zibo Municipal Hospital and Mianyang Central Hospital. Results of this study will be disseminated through peer-reviewed publication. TRIAL REGISTRATION NUMBER: NCT06138210.
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