Evidence map›Paper›PMID 35820718›Full record

ArticleLupus science & medicine2022

Safety, immunological effects and clinical response in a phase I trial of umbilical cord mesenchymal stromal cells in patients with treatment refractory SLE.

Diane L Kamen, Caroline Wallace, Zihai Li, Megan Wyatt, Crystal Paulos, Chungwen Wei, Hongjun Wang, Bethany J Wolf, Paul J Nietert, Gary Gilkeson

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Lupus science & medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03171194 (A Phase I Safety Trial of Allogeneic Mesenchymal Stem Cells for Systemic Lupus Erythematosus), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
6.4field-weighted citation impact, top 3% 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.

NCT03171194 phase1completednot on this map

A Phase I Safety Trial of Allogeneic Mesenchymal Stem Cells for Systemic Lupus Erythematosus

TypeinterventionalSponsorMedical University of South CarolinaRan2017 to 2018Enrolled6ConditionsSystem, Lupus ErythematosusArmsLow Dose Mesenchymal Stem Cells (MSCs)
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 42 citations in OpenAlex.

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  12. Utilization of Stem Cells in Medicine: A Narrative Review.International journal of molecular sciences · 2025
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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

10 authors at 4 institutions in 1 country.

Diane L KamenDepartment of Medicine, Division of Rheumatology, Medical University of South Carolina, Charleston, South Carolina, USA.
Caroline WallaceDepartment of Medicine, Division of Rheumatology, Medical University of South Carolina, Charleston, South Carolina, USA.
Zihai LiDepartment of Medicine, Division of Hematology/Oncology, Ohio State Wexner Medical Center, Columbus, Ohio, USA.
Megan WyattDepartment of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.
Crystal PaulosDepartment of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.
Chungwen WeiUniversity of Rochester Medical Center, Rochester, New York, USA.
Hongjun WangDepartment of Surgery, Medical University of South Carolina, Charleston, South Carolina, USA.
Bethany J WolfDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Paul J NietertDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Gary GilkesonDepartment of Medicine, Division of Rheumatology, Medical University of South Carolina, Charleston, South Carolina, USA gilkeson@musc.edu.ORCID 0000-0003-4228-3574
Medical University of South Carolina · USEmory University · USThe Ohio State University Wexner Medical Center · USUniversity of Rochester Medical Center · US

Funding

SOUTH CAROLINA CLINICAL & TRANSLATIONAL RESEARCH INSTITUTE (SCTR)UL1RR029882 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2009 to 2011
$10.1M
Cellular Therapy for Type 1 Diabetes using Mesenchymal Stem CellsR01DK118529 · NIDDK · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI WANG, HONGJUN · 2019 to 2025
$3.8M
Autologous BM-MSCs and Islet Co-transplantation to Enhance Islet Survival and Function in TP-IAT PatientsR01DK126454 · NIDDK · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI WANG, HONGJUN · 2021 to 2025
$3.2M
Novel Gene and Stem Cell Therapy for Type 1 DiabetesR01DK120394 · NIDDK · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI WANG, HONGJUN · 2018 to 2021
$2.2M
NCRR NIH HHS UL1 RR029882NIDDK NIH HHS R01 DK118529NIDDK NIH HHS R01 DK120394NIDDK NIH HHS R01 DK126454
6 · The paper itself

Abstract

backgroundReports of clinical improvement following mesenchymal stromal cell (MSC) infusions in refractory lupus patients at a single centre in China led us to perform an explorative phase I trial of umbilical cord derived MSCs in patients refractory to 6 months of immunosuppressive therapy.

methodsSix women with a SLEDAI >6, having failed standard of care therapy, received one intravenous infusion of 1×10

resultsOf six patients, five (83.3%; 95% CI 35.9% to 99.6%) achieved the clinical endpoint of an SRI of 4. Adverse events were minimal. Mechanistic studies revealed significant reductions in CD27IgD double negative B cells, switched memory B cells and activated naïve B cells, with increased transitional B cells in the five patients who met the endpoint. There was a trend towards decreased autoantibody levels in specific patients. Two patients had increases in their Helios+Treg cells, but no other significant T cell changes were noted. GARP-TGFβ complexes were significantly increased following the MSC infusions. The B cell changes and the GARP-TGFβ increases significantly correlated with changes in SLEDAI scores.

conclusionThis phase 1 trial suggests that umbilical cord (UC) MSC infusions are very safe and may have efficacy in lupus. The B cell and GARP-TGFβ changes provide novel insight into mechanisms by which MSCs may impact disease. TRIAL REGISTRATION NUMBER: NCT03171194.

Indexed as

Lupus Erythematosus, SystemicMesenchymal Stem CellsMesenchymal Stem Cell TransplantationFemaleHumansTransforming Growth Factor betaUmbilical CordTransforming Growth Factor betaAutoimmunityB-LymphocytesLupus Erythematosus, Systemic

Identifiers

PMID35820718
PMCPMC9277402
OpenAlexW4285099045

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.