Evidence map›Paper›PMID 25413276›Full record

ArticleTransfusion2015

A safety study on intrathecal delivery of autologous mesenchymal stromal cells in rabbits directly supporting Phase I human trials.

Bingkun K Chen, Nathan P Staff, Andrew M Knight, Jarred J Nesbitt, Greg W Butler, Douglas J Padley, Joseph E Parisi, Allan B Dietz, Anthony J Windebank

Open access · greenAbstract read
In one paragraph

Article in Transfusion, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

16 citing papers in PubMed, 31 citations in OpenAlex.

  1. Review
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  5. Regenerative Stem Cell Therapy for Neurodegenerative Diseases: An Overview.International journal of molecular sciences · 2021
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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

9 authors at 2 institutions in 1 country.

Bingkun K ChenDepartment of Neurology, Mayo Clinic, Rochester, Minnesota.
Nathan P StaffDepartment of Neurology, Mayo Clinic, Rochester, Minnesota.
Andrew M KnightDepartment of Neurology, Mayo Clinic, Rochester, Minnesota.
Jarred J NesbittDepartment of Neurology, Mayo Clinic, Rochester, Minnesota.
Greg W ButlerHuman Cell Therapy Laboratory, Mayo Clinic, Rochester, Minnesota.
Douglas J PadleyHuman Cell Therapy Laboratory, Mayo Clinic, Rochester, Minnesota.
Joseph E ParisiDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
Allan B DietzHuman Cell Therapy Laboratory, Mayo Clinic, Rochester, Minnesota.
Anthony J WindebankDepartment of Neurology, Mayo Clinic, Rochester, Minnesota.
Mayo Clinic · USMayo Clinic in Florida · US

Funding

Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
Mechanisms of Bortezomib-induced Peripheral NeuropathyK08CA169443 · NCI · MAYO CLINIC ROCHESTER · PI STAFF, NATHAN P · 2012 to 2016
$722k
NCATS NIH HHS UL1 TR000135NCI NIH HHS K08 CA169443PHS HHS K08 169443
6 · The paper itself

Abstract

backgroundThere are no effective treatments that slow the progression of neurodegenerative diseases. A major challenge of treatment in neurodegenerative diseases is appropriate delivery of pharmaceuticals into the cerebrospinal fluid (CSF) of affected individuals. Mesenchymal stromal cells (MSCs-either naïve or modified) are a promising therapy in neurodegenerative diseases and may be delivered directly into the CSF where they can reside for months. In this preclinical study, we evaluated the safety of intrathecal autologous MSCs in a rabbit model. STUDY DESIGN AND

methodsAutologous adipose-derived MSCs (or artificial CSF) were delivered intrathecally, either with single or with repeated injections into the foramen magnum of healthy rabbits and monitored for 4 and 12 weeks, respectively.

resultsRabbits tolerated injections well and no definitive MSC-related side effects were observed apart from three rabbits that had delayed death secondary to traumatic foramen magnum puncture. Functional assessments and body weights were equivalent between groups. Gross pathology and histology did not reveal any abnormalities or tumor growth. Complete blood count data were normal and there were no differences in CSF interleukin-6 levels in all groups tested.

conclusionOur data suggest that intrathecal delivery of autologous MSCs is safe in a rabbit model. Data from this study have supported two successful investigational new drug applications to the Food and Drug Administration, resulting in the initiation of two clinical trials using autologous MSCs in amyotrophic lateral sclerosis and multiple system atrophy.

Indexed as

Mesenchymal Stem Cell TransplantationAmyotrophic Lateral SclerosisAnimalsCells, CulturedClinical Trials, Phase I as TopicDisease Models, AnimalFemaleHumansInjections, SpinalInterleukin-6MaleMesenchymal Stem CellsMultiple System AtrophyOrgan SizeRabbitsInterleukin-6

Identifiers

PMID25413276
PMCPMC4428970
OpenAlexW1534936202

What OpenQuestion holds

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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.