Evidence map›Paper›PMID 35241141›Full record

Trial reportStem cell research & therapy2022

Safety and efficacy of autologous, adipose-derived mesenchymal stem cells in patients with rheumatoid arthritis: a phase I/IIa, open-label, non-randomized pilot trial.

Ridhima Vij, Kevin A Stebbings, Hosu Kim, Hyeonggeun Park, Donna Chang

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cell research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03691909 (A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis), which is not on this map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 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.

NCT03691909 phase1 / phase2completednot on this map

A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis

TypeinterventionalSponsorHope Biosciences LLCRan2018 to 2020Enrolled15ConditionsRheumatoid ArthritisArmsHB-adMSCs
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

5 authors.

Ridhima Vij *Hope Biosciences Stem Cell Research Foundation, 16700 Creek bend Dr., Sugar Land, TX, 77478, USA. ridhima@hopebio.org.ORCID 0000-0003-3130-5133
Kevin A Stebbings *Hope Biosciences Stem Cell Research Foundation, 16700 Creek bend Dr., Sugar Land, TX, 77478, USA.ORCID 0000-0002-9130-0812
Hosu KimHope Biosciences, Sugar Land, TX, USA.
Hyeonggeun ParkHope Biosciences, Sugar Land, TX, USA.
Donna ChangHope Biosciences, Sugar Land, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe present study is a phase I/IIa non-randomized, open-label study to evaluate safety and efficacy of a single, intravenous infusion of autologous, adipose-derived mesenchymal stem cells (adMSCs) over a period of 52 weeks, in patients with active rheumatoid arthritis (RA).

methods15 eligible RA patients aged 18-65 years were enrolled and followed up at weeks 4, 12, 26 and 52 after receiving a single intravenous dose of 2 × 10

resultsACR66/68 scores for both S/TJC showed significant improvements with large effect sizes (ES) at week 52 vs baseline (p < 0.01, ES = 0.83 and p < 0.001, ES = 0.93 respectively). Medium to large ES were also obvious for ACR66/68 scores measured at other timepoints. Levels of inflammatory markers, TNF-α, IL-6 and ESR remained unchanged compared to baseline. However, a difference in CRP levels with a small effect size was observed at week 4 (p = 0.229, ES = 0.33) with further improvement at week 52 (p = 0.183, ES = 0.37). Post-intervention, levels of hematologic, hepatic, and renal function remained largely unchanged (p > 0.05). No acute or long-term serious adverse events (AEs) occurred.

conclusionsThe results indicated that a single, intravenous administration of autologous adMSCs is safe and efficacious for improvement in joint function in patients with active RA. Data from the current study supports the exploration of ad-MSCs as a therapeutic intervention for RA. Trial Registration Clinical trial registration number: NCT03691909. Registered September 27, 2018- Retrospectively registered ( https://clinicaltrials.gov/show/NCT03691909 ).

Indexed as

Antirheumatic AgentsArthritis, RheumatoidMesenchymal Stem CellsAdolescentAdultAgedDouble-Blind MethodHumansMiddle AgedTreatment OutcomeTumor Necrosis Factor-alphaYoung AdultAntirheumatic AgentsTumor Necrosis Factor-alphaAdipose-derived mesenchymal stem cellAutologousClinical trialEfficacyIntravenousRheumatoid arthritis

Identifiers

PMID35241141
PMCPMC8896321

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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.