Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: The immunomodulatory actions of human umbilical cord blood (hUCB)-derived mesenchymal stem cells (MSCs) in rheumatoid arthritis (RA) have been studied extensively via in vitro or pre-clinical studies, yet few human trials have been conducted investigating the outcome of hUCB-derived MSC infusion.
Methods: The CURE-iv (
Results: Eleven RA patients were screened, 9 of which were enrolled from a single center. The mean age was 57.4 years, 78 % being female, with a disease duration of 9.5 ± 8.7 years, and DAS28-ESR 4.53 ± 1.35. There was no ominous safety signal in all clusters up to 4 weeks after the infusion. One patient stated joint pain 60 min after the infusion (5 x 107 group), but it was thought to be unrelated to the investigational product. ESR and CRP changes at 4 weeks (n=9) were -7.89 ± 10.36 (p= 0.0517), and -0.37 ± 1.09 (p=0.3362). DAS28 and HAQ changes at 4 weeks were -1.60 ± 1.57 (p= 0.0159), and -0.15 ± 0.48 (p= 0.3706), respectively. One patient in the 1 x 108 group showed substantial decrease in all serum levels of IL-1b, IL-6, IL-8, and TNF-a.
Conclusion: This phase 1 clinical trial – a single dose intravenous infusion of hUCB-derived MSCs – for established RA patients was completed without any short-term safety concerns (NCT02221258).
To cite this abstract in AMA style:Go DJ, Lim HS, Cho A, Roh K, Seo KW, Kang KS, Shin K. Intravenous Infusion of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in Rheumatoid Arthritis: A Phase 1, Proof-of-Concept Clinical Trial [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/intravenous-infusion-of-umbilical-cord-blood-derived-mesenchymal-stem-cells-in-rheumatoid-arthritis-a-phase-1-proof-of-concept-clinical-trial/. Accessed November 28, 2020.
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