Evidence map›Paper›PMID 31098715›Full record

ReviewEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2019

Stem cell/cellular interventions in human spinal cord injury: Is it time to move from guidelines to regulations and legislations? Literature review and Spinal Cord Society position statement.

Harvinder S Chhabra, Kanchan Sarda, Geeta Jotwani, M Gourie-Devi, Erkan Kaptanoglu, Susan Charlifue, S L Yadav, B Mohapatra, Abhishek Srivastava, Kedar Phadke

Abstract readReviewConsensus Statement
PubMed Publisher
In one paragraph

Review in 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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

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

  1. Pooled it
  2. Review
  3. Article
  4. Cell transplantation to repair the injured spinal cord.International review of neurobiology · 2022
    Article
  5. Review
  6. 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.

Harvinder S ChhabraSpine Unit, Indian Spinal Injuries Centre, New Delhi, India. drhschhabra@isiconline.org.ORCID http://orcid.org/0000-0001-5519-9609
Kanchan SardaDepartment of Basic Research, Indian Spinal Injuries Centre, New Delhi, India.
Geeta JotwaniIndian Council of Medical Research, New Delhi, India.
M Gourie-DeviDepartment of Neurology, Institute of Human Behaviour and Allied Sciences (IHBAS), New Delhi, India.
Erkan KaptanogluDepartment of Neurosurgery, Marmara University, Istanbul, Turkey.
Susan CharlifueCraig Hospital, Englewood, CO, USA.
S L YadavDepartment of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi, India.
B MohapatraSpine Unit, Indian Spinal Injuries Centre, New Delhi, India.
Abhishek SrivastavaSpine Unit, Indian Spinal Injuries Centre, New Delhi, India.
Kedar PhadkeSpine Unit, Indian Spinal Injuries Centre, New Delhi, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn preclinical studies, many stem cell/cellular interventions demonstrated robust regeneration and/or repair in case of SCI and were considered a promising therapeutic candidate. However, data from clinical studies are not robust. Despite lack of substantial evidence for the efficacy of these interventions in spinal cord injury (SCI), many clinics around the world offer them as "therapy." These "clinics" claim efficacy through patient testimonials and self-advertisement without any scientific evidence to validate their claims. Thus, SCS established a panel of experts to review published preclinical studies, clinical studies and current global guidelines/regulations on usage of cellular transplants and make recommendations for their clinical use.

methodsThe literature review and draft position statement was compiled and circulated among the panel and relevant suggestions incorporated to reach consensus. This was discussed and finalized in an open forum during the SCS Annual Meeting, ISSICON.

resultsPreclinical evidence suggests safety and clinical potency of cellular interventions after SCI. However, evidence from clinical studies consisted of mostly case reports or uncontrolled case series/studies. Data from animal studies cannot be generalized to human SCI with regard to toxicity prediction after auto/allograft transplantation.

conclusionsCurrently, cellular/stem cell transplantation for human SCI is experimental and needs to be tested through a valid clinical trial program. It is not ethical to provide unproven transplantation as therapy with commercial implications. To stop the malpractice of marketing such "unproven therapies" to a vulnerable population, it is crucial that all countries unite to form common, well-defined regulations/legislation on their use in SCI. These slides can be retrieved from Electronic Supplementary Material.

Indexed as

Stem Cell TransplantationAnimalsHumansPractice Guidelines as TopicSpinal Cord InjuriesAcute paraplegiaCellular interventionsClinical trialGuidelinesPosition statementRegulationsSpinal cord injuryStem cell

Identifiers

PMID31098715

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.