Evidence map›Paper›PMID 39183334›Full record

ArticleStem cell research & therapy2024

Safety and potential effects of intrathecal injection of allogeneic human umbilical cord mesenchymal stem cell-derived exosomes in complete subacute spinal cord injury: a first-in-human, single-arm, open-label, phase I clinical trial.

Mohammadhosein Akhlaghpasand, Roozbeh Tavanaei, Maede Hosseinpoor, Kaveh Oraii Yazdani, Afsane Soleimani, Mojtaba Yousefi Zoshk, Masoud Soleimani, Mohsen Chamanara, Mahdi Ghorbani, Mohammad Deylami and 3 more

Abstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Stem cell research & therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  13. Extracellular vesicles in spine tumors: biological roles, immune modulation, and therapeutic implications.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Mohammadhosein Akhlaghpasand *Medical Biotechnology Research Center, AJA University of Medical Sciences, PO box: 1411718541, Tehran, Iran.
Roozbeh Tavanaei *Medical Biotechnology Research Center, AJA University of Medical Sciences, PO box: 1411718541, Tehran, Iran.
Maede HosseinpoorFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, PO box: 1988873554, Tehran, Iran.
Kaveh Oraii YazdaniDepartment of cardiovascular diseases, Zahedan university of medical science, Zahedan, Iran.
Afsane SoleimaniFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, PO box: 1988873554, Tehran, Iran.
Mojtaba Yousefi ZoshkDepartment of Pediatrics, Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran.
Masoud SoleimaniDepartment of Hematology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.
Mohsen ChamanaraDepartment of Pharmacology, School of Medicine, AJA University of Medical Sciences, Tehran, Iran.
Mahdi GhorbaniMedical Biotechnology Research Center, AJA University of Medical Sciences, PO box: 1411718541, Tehran, Iran.
Mohammad DeylamiDepartment of ICU &Critical care, Faculty of Medicine, Loghman-e Hakim Hospital, Shahid Beheshti University of Medical Science, Tehran, Iran.
Alireza ZaliFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, PO box: 1988873554, Tehran, Iran.
Reza HeidariMedical Biotechnology Research Center, AJA University of Medical Sciences, PO box: 1411718541, Tehran, Iran. r-heidary@ajaums.ac.ir.
Saeed Oraee-YazdaniFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, PO box: 1988873554, Tehran, Iran. saeed.o.yazdani@gmail.com.

Funding

Shahid Beheshti University of Medical Sciences IR.SBMU.MSP.REC.1399.235
6 · The paper itself

Abstract

objectiveNeurological and functional impairments are commonly observed in individuals with spinal cord injury (SCI) due to insufficient regeneration of damaged axons. Exosomes play a crucial role in the paracrine effects of mesenchymal stem cells (MSCs) and have emerged as a promising therapeutic approach for SCI. Thus, this study aimed to evaluate the safety and potential effects of intrathecal administration of allogeneic exosomes derived from human umbilical cord MSCs (HUC-MSCs) in patients with complete subacute SCI.

methodsThis study was a single-arm, open-label, phase I clinical trial with a 12-month follow-up period. HUC-MSCs were extracted from human umbilical cord tissue, and exosomes were isolated via ultracentrifugation. After intrathecal injection, each participant a underwent complete evaluation, including neurological assessment using the American Spinal Injury Association (ASIA) scale, functional assessment using the Spinal Cord Independence Measure (SCIM-III), neurogenic bowel dysfunction (NBD) assessment using the NBD score, modified Ashworth scale (MAS), and lower urinary tract function questionnaire.

resultsNine patients with complete subacute SCI were recruited. The intrathecal injection of allogeneic HUC-MSCs-exosomes was safe and well tolerated. No early or late adverse event (AE) attributable to the study intervention was observed. Significant improvements in ASIA pinprick (P-value = 0.039) and light touch (P-value = 0.038) scores, SCIM III total score (P-value = 0.027), and NBD score (P-value = 0.042) were also observed at 12-month after the injection compared with baseline.

conclusionsThis study demonstrated that intrathecal administration of allogeneic HUC-MSCs-exosomes is safe in patients with subacute SCI. Moreover, it seems that this therapy might be associated with potential clinical and functional improvements in these patients. In this regard, future larger phase II/III clinical trials with adequate power are highly required.

trial registrationIranian Registry of Clinical Trials, IRCT20200502047277N1. Registered 2 October 2020, https://en.irct.ir/trial/48765 .

Indexed as

ExosomesInjections, SpinalMesenchymal Stem CellsMesenchymal Stem Cell TransplantationSpinal Cord InjuriesUmbilical CordAdultFemaleHumansMaleMiddle AgedTransplantation, HomologousYoung AdultExosomesMesenchymal stem cellsNeuroprotectionSpinal cord injury

Identifiers

PMID39183334
PMCPMC11346059

What OpenQuestion holds

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Registered trials

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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.