Clinical and laboratory findings following transplantation of allogeneic adipose-derived mesenchymal stromal cells in knee osteoarthritis, a brief report

ABSTRACT

Background

Mesenchymal stromal cells (MSCs) injection has been proposed as an innovative treatment for knee osteoarthritis (KOA). Since, allogeneic MSCs can be available as off-the-shelf products, they are preferable in regenerative medicine. Among different sources for MSCs, adipose-derived MSCs (AD-MSCs) appear to be more available.

Methods

Three patients with KOA were enrolled in this study. A total number of 100 × 10⁶ AD-MSCs was injected intra-articularly, per affected knee. They were followed up for 6 months by the assessment of clinical outcomes, magnetic resonance imaging (MRI), and serum inflammatory biomarkers.

Results

The primary outcome of this study was safety and feasibility of allogeneic AD-MSCs injection during the 6 months follow-up. Fortunately, no serious adverse events (SAEs) were reported. Assessment of secondary outcomes of visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and knee osteoarthritis outcome score (KOOS) indicated improvement in all patients. Comparison between baseline and endpoint findings of MRI demonstrated a slight improvement in two patients. In addition, decrease in serum cartilage oligomeric matrix protein (COMP) and hyaluronic acid (HA) indicated the possibility of reduced cartilage degeneration. Moreover, quantification of serum interleukin-10 (IL-10) and interleukin-6 (IL-6) levels indicated that the host immune system immunomodulated after infusion of AD-MSCs.

Conclusion

Intra-articular injection of AD-MSCs is safe and could be effective in cartilage regeneration in KOA. Preliminary assessment after six-month follow-up suggests the potential efficacy of this intervention which would need to be confirmed in randomized controlled trials on a larger population.

Trial registration

This study was registered in the Iranian registry of clinical trials (https://en.irct.ir/trial/46) in 24 April 2018 with identifier IRCT20080728001031N23.

KEYWORDS:

• Allogeneic mesenchymal stromal cells
• cartilage regeneration
• inflammatory biomarkers
• knee osteoarthritis
• regenerative medicine

Acknowledgment

We would like to express our gratitude to our colleagues in the regenerative medicine department, Royan institute.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Authors’contributions

B.S., S.N., M.M., S.K.T., M.H., and M.G.L. collected data. B.S. drafted the manuscript. A.T. and M.V. reviewed the manuscript and checked the scientific content. A.B., H.M., and M.B. performed critical reviewing of the manuscript. A.B.M. performed language polishing. M.M. and N.N. analyzed MRI findings. A.B.F., J.M., and M.V. developed the concept and outlines, and confirmed the final manuscript.

Availability of data and materials

All data generated or analyzed during this study are included in this published article [and its supplementary information files].

Ethics approval and consent to participate

The study included only adults and written informed consent have been obtained from the patients. All procedures were conducted in accordance with the relevant approved regulations, guidelines, and the Declaration of Helsinki. This study was approved by the Ethics Committee of the Royan Institute (IR.ACECR.ROYAN.REC.1396.138) and registered in the Iranian Registry of Clinical Trials (https://www.irct.ir) with identifier IRCT20080728001031N23.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/03008207.2022.2074841

Additional information

Funding

This work was supported by grants from Iran Ministry of Health and Medical Education to J.M. and the Royan Institute for Stem Cell Biology and Technology to M.V. The funding sources had no responsibilities in the study design; data collection, analysis, and interpretation; manuscript writing; and in the decision to submit this paper for publication.