Combination of human umbilical cord mesenchymal stem (stromal) cell transplantation with IFN-γ treatment synergistically improves the clinical outcomes of patients with rheumatoid arthritis

Ann Rheum Dis. 2020 Oct;79(10):1298-1304. doi: 10.1136/annrheumdis-2020-217798. Epub 2020 Jun 19.

Abstract

Objectives: To clarify the key role of circulating interferon-γ (IFN-γ) and to improve the clinical efficacy of mesenchymal stem cell (MSC) transplantation (MSCT) in patients with rheumatoid arthritis (RA).

Methods: Study of wild-type or IFN-γR-/- MSCT was first evaluated in a murine model of collagen-induced arthritis (CIA) following which a phase 1/2 randomised controlled study was conducted in 63 patients with RA who responded poorly to regular clinical treatments. Subjects were randomly assigned to an MSCT monotherapy group (n=32) or an MSCT plus recombinant human IFN-γ treatment group (n=31), with 1 year of follow-up. The primary end points consisted of efficacy as assessed as good or moderate EULAR response rates and the proportion of patients at 3 months attaining American College of Rheumatology 20 (ACR20) response rates.

Results: In the murine studies, wild-type MSCT significantly improved the clinical severity of CIA, while IFN-γR-/- MSCT aggravated synovitis, and joint and cartilage damage. Transitioning from the murine to the clinical study, the 3-month follow-up results showed that the efficacy and ACR20 response rates were attained in 53.3% patients with MSCT monotherapy and in 93.3% patients with MSCT combined with IFN-γ treatment (p<0.05). No new or unexpected safety issues were encountered in 1-year follow-up for either treatment group.

Conclusions: The results of this study show that IFN-γ is a key factor in determining the efficacy of MSCT in the treatment of RA, and that an MSC plus IFN-γ combination therapeutic strategy can greatly improve the clinical efficacy of MSC-based therapy in RA patients.

Keywords: arthritis, rheumatoid; inflammation; therapeutics.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Animals
  • Arthritis, Experimental
  • Arthritis, Rheumatoid / therapy*
  • Combined Modality Therapy / methods*
  • Cord Blood Stem Cell Transplantation / methods
  • Female
  • Humans
  • Immunologic Factors / therapeutic use*
  • Interferon-gamma / therapeutic use*
  • Male
  • Mesenchymal Stem Cell Transplantation / methods*
  • Mice
  • Middle Aged
  • Recombinant Proteins / therapeutic use

Substances

  • IFNG protein, human
  • Immunologic Factors
  • Recombinant Proteins
  • Interferon-gamma