NCT03171194

Pilot Trial of Mesenchymal Stem Cells for Systemic Lupus Erythematosus

Completed Phase 1 Last updated 2 May 2019

What this trial tests

Phase 1 trial testing Low Dose Mesenchymal Stem Cells (MSCs) in System; Lupus Erythematosus in 6 participants. Completed in 25 October 2018.

Timeline

27 April 2017

Primary endpoint
30 April 2018

25 October 2018

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	27 April 2017
Primary completion	30 April 2018
Estimated completion	25 October 2018
Sites	2 locations across United States

Drugs / interventions tested

• Low Dose Mesenchymal Stem Cells (MSCs) — full drug profile →

Conditions studied

• System; Lupus Erythematosus — all drugs for System; Lupus Erythematosus →

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 65, any sex, with System; Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety of mesenchymal stromal cells (MSCs) obtained from umbilical cords for the treatment of adults with active systemic lupus erythematosus (SLE).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Shattering barriers toward clinically meaningful MSC therapies.
   Levy O, Kuai R, Siren EMJ, Bhere D, et al · · 2020 · cited 501× · PMID 32832666 · DOI 10.1126/sciadv.aba6884
2. Clinical Trials Based on Mesenchymal Stromal Cells are Exponentially Increasing: Where are We in Recent Years?
   Galderisi U, Peluso G, Di Bernardo G. · · 2022 · cited 175× · PMID 34398443 · DOI 10.1007/s12015-021-10231-w
3. Mesenchymal stem/stromal cells as a valuable source for the treatment of immune-mediated disorders.
   Markov A, Thangavelu L, Aravindhan S, Zekiy AO, et al · · 2021 · cited 174× · PMID 33736695 · DOI 10.1186/s13287-021-02265-1
4. Immunomodulatory Mechanisms of Mesenchymal Stem Cells and Their Potential Clinical Applications.
   Huang Y, Wu Q, Tam PKH. · · 2022 · cited 143× · PMID 36077421 · DOI 10.3390/ijms231710023
5. Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
   Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0
6. Adipose Stem Cell Translational Applications: From Bench-to-Bedside.
   Argentati C, Morena F, Bazzucchi M, Armentano I, et al · · 2018 · cited 63× · PMID 30400641 · DOI 10.3390/ijms19113475
7. Pharmacokinetic characteristics of mesenchymal stem cells in translational challenges.
   Shan Y, Zhang M, Tao E, Wang J, et al · · 2024 · cited 47× · PMID 39271680 · DOI 10.1038/s41392-024-01936-8
8. Mesenchymal stem cells in treating human diseases: molecular mechanisms and clinical studies.
   Han X, Liao R, Li X, Zhang C, et al · · 2025 · cited 34× · PMID 40841367 · DOI 10.1038/s41392-025-02313-9