Autologous mesenchymal stromal cells and kidney transplantation: a pilot study of safety and clinical feasibility

Clin J Am Soc Nephrol. 2011 Feb;6(2):412-22. doi: 10.2215/CJN.04950610. Epub 2010 Oct 7.


Background and objectives: Mesenchymal stromal cells (MSCs) abrogate alloimmune response in vitro, suggesting a novel cell-based approach in transplantation. Moving this concept toward clinical application in organ transplantation should be critically assessed.

Design, setting, participants & measurements: A safety and clinical feasibility study (, NCT00752479) of autologous MSC infusion was conducted in two recipients of kidneys from living-related donors. Patients were given T cell-depleting induction therapy and maintenance immunosuppression with cyclosporine and mycophenolate mofetil. On day 7 posttransplant, MSCs were administered intravenously. Clinical and immunomonitoring of MSC-treated patients was performed up to day 360 postsurgery.

Results: Serum creatinine levels increased 7 to 14 days after cell infusion in both MSC-treated patients. A graft biopsy in patient 2 excluded acute graft rejection, but showed a focal inflammatory infiltrate, mostly granulocytes. In patient 1 protocol biopsy at 1-year posttransplant showed a normal graft. Both MSC-treated patients are in good health with stable graft function. A progressive increase of the percentage of CD4+CD25highFoxP3+CD127- Treg and a marked inhibition of memory CD45RO+RA-CD8+ T cell expansion were observed posttransplant. Patient T cells showed a profound reduction of CD8+ T cell activity.

Conclusions: Findings from this study in the two patients show that MSC infusion in kidney transplant recipients is feasible, allows enlargement of Treg in the peripheral blood, and controls memory CD8+ T cell function. Future clinical trials with MSCs to look with the greatest care for unwanted side effects is advised.

Publication types

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

MeSH terms

  • Adult
  • Biomarkers / blood
  • Biopsy
  • CD8-Positive T-Lymphocytes / immunology
  • Cells, Cultured
  • Creatinine / blood
  • Drug Therapy, Combination
  • Feasibility Studies
  • Humans
  • Immunohistochemistry
  • Immunologic Memory
  • Immunophenotyping
  • Immunosuppressive Agents / therapeutic use
  • Kidney Failure, Chronic / surgery*
  • Kidney Transplantation* / adverse effects
  • Kidney Transplantation* / immunology
  • Living Donors
  • Male
  • Mesenchymal Stem Cell Transplantation* / adverse effects
  • Pilot Projects
  • T-Lymphocytes, Regulatory / immunology
  • Time Factors
  • Transplantation Conditioning
  • Transplantation, Autologous
  • Treatment Outcome
  • Young Adult


  • Biomarkers
  • Immunosuppressive Agents
  • Creatinine

Associated data