Evidence map›Paper›PMID 40503363›Full record

Trial reportWorld journal of stem cells2025

Multiroute administration of Wharton's jelly mesenchymal stem cells in chronic complete spinal cord injury: A phase I safety and feasibility study.

Necati Kaplan, Serdar Kabatas, Erdinç Civelek, Eyüp Can Savrunlu, Tolga Akkoc, Osman Boyalı, Erek Öztürk, Halil Can, Ali Genc, Erdal Karaöz

Abstract readClinical Trial
In one paragraph

Trial report in World journal of stem cells, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

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

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
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

10 authors.

Necati KaplanDepartment of Neurosurgery, Istanbul Rumeli University, Çorlu Reyap Hospital, Tekirdağ 59860, Türkiye.
Serdar KabatasDepartment of Neurosurgery, University of Health Sciences Türkiye, Gaziosmanpaşa Training and Research Hospital, Istanbul 34255, Türkiye.
Erdinç CivelekDepartment of Neurosurgery, University of Health Sciences Türkiye, Gaziosmanpaşa Training and Research Hospital, Istanbul 34255, Türkiye.
Eyüp Can SavrunluDepartment of Neurosurgery, Versa Hospital, Nevşehir 50300, Türkiye.
Tolga AkkocTubitak Marmara Research Center, Genetic Engineering and Biotechnology Institute, Kocaeli 41470, Türkiye.
Osman BoyalıDepartment of Neurosurgery, University of Health Sciences Türkiye, Gaziosmanpaşa Training and Research Hospital, Istanbul 34255, Türkiye.
Erek ÖztürkDepartment of Neurosurgery, Orthopaediezentrum Magdeburg, Magdeburg 39112, Saxony-Anhalt, Germany.
Halil CanDepartment of Neurosurgery, Atlas University, İstanbul 34408, Türkiye.
Ali GencDepartment of Neurosurgery, Palmiye Hospital, Hatay 31200, Türkiye.
Erdal KaraözCenter for Regenerative Medicine and Stem Cell Research & Manufacturing, Liv Hospital, Istanbul 34340, Türkiye.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTraumatic spinal cord injury (SCI) is a life-altering condition that results in long-term complications, including progressive neurodegeneration and cord atrophy. It presents a significant unmet medical need with extensive social and economic burdens.

aimTo evaluate the safety and preliminary efficacy of allogeneic mesenchymal stem cells derived from Wharton's jelly (WJ-MSCs) in patients with chronic complete SCI. The primary objective was to assess whether WJ-MSCs could facilitate neurological recovery and improve the quality of life in this patient population.

methodsThis open-label, multicenter phase I study investigated the effects of administering WJ-MSCs

resultsAt baseline, participants displayed considerable functional deficits, as indicated by the following scores: Functional independence measure of 77.5 ± 2.26; Modified Ashworth Scale of 15.83 ± 4.83; American Spinal Injury Association (ASIA) Motor score of 1.67 ± 2.66; ASIA Light Touch and Pin-Prick scores of 62 ± 18.42 each; Wexner Incontinence Score of 20; and Qualiveen Short Form, a validated questionnaire specifically designed to assess the impact of urinary dysfunction on quality of life in individuals with SCI, score of 32. Following WJ-MSC therapy, significant improvements were observed in all neurological functions over the 1-year follow-up. Notably, the ASIA Motor score improved significantly (

conclusionThis phase I study, conducted without a control group, suggests that the administration of WJ-MSCs through multiple routes is both safe and potentially effective in patients with chronic complete SCI. However, the observed neurological improvements cannot be solely attributed to WJ-MSC therapy, as concurrent pharmacological and rehabilitative interventions were not controlled. These findings indicated that WJ-MSC therapy may offer a promising approach for enhancing neurological function and quality of life in this challenging patient population. Further research with larger cohorts and extended follow-up is necessary to validate these preliminary results.

Indexed as

Mesenchymal stem cellNeurological recoverySpinal cord injuryTransplantationWharton’s jelly

Identifiers

PMID40503363
PMCPMC12149795

What Socratic holds

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LicenceCC BY-NC
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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 Socratic graph.