Evidence map›Paper›PMID 34504283›Full record

ArticleSpinal cord2022

Safety and feasibility of autologous olfactory ensheathing cell and bone marrow mesenchymal stem cell co-transplantation in chronic human spinal cord injury: a clinical trial.

Homa Zamani, Mina Soufizomorrod, Saeed Oraee-Yazdani, Dariush Naviafar, Mohammadhosein Akhlaghpasand, Afsoun Seddighi, Masoud Soleimani

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Spinal cord, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
4.3field-weighted citation impact, top 5% of its field
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

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Spinal cord injury: molecular mechanisms and therapeutic interventions.Signal transduction and targeted therapy · 2023
    Review
  19. Review
  20. Review
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

7 authors at 2 institutions in 1 country.

Homa ZamaniDepartment of Cell Therapy and Hematology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.
Mina SoufizomorrodDepartment of Cell Therapy and Hematology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. m.soufi@modares.ac.ir.
Saeed Oraee-YazdaniFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, Iran. saeed_o_yazdani@sbmu.ac.ir.
Dariush NaviafarDepartment of Neurosurgery, Erfan Hospital, Tehran, Iran.
Mohammadhosein AkhlaghpasandFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Afsoun SeddighiFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Masoud SoleimaniDepartment of Cell Therapy and Hematology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. soleim_m@modares.ac.ir.ORCID http://orcid.org/0000-0003-1972-7771
Shahid Beheshti University of Medical Sciences · IRTarbiat Modares University · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designThis is a phase I clinical trial.

objectivesOur objective was to assess the safety and feasibility of autologous mucosal olfactory ensheathing cell (OEC) and bone marrow mesenchymal stem cell (MSC) co-transplantation in people with chronic, complete (American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification A) spinal cord injury (SCI).

settingThis study was performed at Shohada Tajrish Hospital, Tehran, Iran.

methodsThree individuals with the traumatic SCI of the thoracic level were enrolled. They received the autologous OEC and MSC combination through the lumbar puncture. All adverse events and possible functional outcomes were documented performing pre- and post-operative general clinical examination, magnetic resonance imaging (MRI), neurological assessment based on the International Standard of Neurological Classification for SCI, and functional evaluation using Spinal Cord Independence Measure version III (SCIM III).

resultsNo serious safety issue was recorded during the 2 years of follow-up. MRI findings remained unchanged with no neoplastic tissue formation. AIS improved from A to B in one of the participants. SCIM III evaluation also showed some degrees of progress in this participant's functional ability. The two other research participants had negligible or no improvement in their sensory scores without any changes in the AIS and SCIM III scores. No motor recovery was observed in any of the participants.

conclusionsOverall, this 2-year trial was not associated with any adverse findings, which may suggest the safety of autologous OEC and bone marrow MSC combination for the treatment of human SCI.

Indexed as

Mesenchymal Stem CellsSpinal Cord InjuriesTransplantation, AutologousFeasibility StudiesHumansIran

Identifiers

PMID34504283
OpenAlexW3158762516

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.