Evidence map›Paper›PMID 31804767›Full record

ArticleStem cells translational medicine2020

Trends in mesenchymal stem cell clinical trials 2004-2018: Is efficacy optimal in a narrow dose range?

Maciej Kabat, Ivan Bobkov, Suneel Kumar, Martin Grumet

2 registry-linked trialsAbstract readHistorical Article
In one paragraph

Article in Stem cells translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 270 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
270citing papers in PubMed, 4 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.

NCT06163833 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

MATRIx: MesenchymAl Stromal Cells for Traumatic bRain Injury

TypeinterventionalSponsorFondazione IRCCS San Gerardo dei TintoriRan2023 to 2026Enrolled78ConditionsTraumatic Brain Injury With Loss of ConsciousnessArmsMesenchymal stromal cell low dosage-80*10^6 cells, Mesenchymal stromal cell low dosage-160*10^6 cells, Placebo-storage solution
NCT06888973 phase1 / phase2enrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Mesenchymal Stem Cells Infusion in Patients With Autoimmune Diseases - A Phase II Clinical Trial

TypeinterventionalSponsorNational Institute of Blood and Marrow Transplant (NIBMT), PakistanRan2025 to 2026Enrolled200ConditionsRheumatoid Arthritis, Systemic Lupus Erythematosus (SLE), Systemic Sclerosis, Ankylosing Spondylitis (AS)ArmsMesenchymal Stem Cells, Placebo
3 · Its place in the literature

Who cites it

270 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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210 more citing papers are in PubMed but not listed here.

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

4 authors.

Maciej KabatW. M. Keck Center for Collaborative Neuroscience, Rutgers Stem Cell Research Center, Department of Cell Biology & Neuroscience, Rutgers University, Piscataway, New Jersey.
Ivan BobkovW. M. Keck Center for Collaborative Neuroscience, Rutgers Stem Cell Research Center, Department of Cell Biology & Neuroscience, Rutgers University, Piscataway, New Jersey.
Suneel KumarDepartment of Biomedical Engineering, Rutgers University, Piscataway, New Jersey.
Martin GrumetW. M. Keck Center for Collaborative Neuroscience, Rutgers Stem Cell Research Center, Department of Cell Biology & Neuroscience, Rutgers University, Piscataway, New Jersey.ORCID 0000-0002-0447-6634

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The number of clinical trials using mesenchymal stem cells (MSCs) has increased since 2008, but this trend slowed in the past several years and dropped precipitously in 2018. Previous reports have analyzed MSC clinical trials by disease, phase, cell source, country of origin, and trial initiation date, all of which can be downloaded directly from ClinicalTrials.gov. We have extended analyses to a larger group of 914 MSC trials reported through 2018. To search for potential factors that may influence the design of new trials, we extracted data on routes of administration and dosing from individual ClinicalTrials.gov records as this information cannot be downloaded directly from the database. Intravenous (IV) injection is the most common, least invasive and most reproducible method, accounting for 43% of all trials. The median dose for IV delivery is 100 million MSCs/patient/dose. Analysis of all trials using IV injection that reported positive outcomes indicated minimal effective doses (MEDs) ranging from 70 to 190 million MSCs/patient/dose in 14/16 trials with the other two trials administering much higher doses of at least 900 million cells. Dose-response data showing differential efficacy for improved outcomes were reported in only four trials, which indicated a narrower MED range of 100-150 million MSCs/patient with lower and higher IV doses being less effective. The results suggest that it may be critical to determine MEDs in early trials before proceeding with large clinical trials.

Indexed as

Clinical Trials as TopicHistory, 21st CenturyHumansMesenchymal Stem Cell TransplantationClinicalTrials.govdoseintravenousmesenchymal stromal cell

Identifiers

PMID31804767
PMCPMC6954709

What OpenQuestion holds

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Registered trials

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.