Long-term safety of umbilical cord mesenchymal stem cells transplantation for systemic lupus erythematosus: a 6-year follow-up study

Abstract

The aim of this study is to assess the long-term safety of allogeneic umbilical cord mesenchymal stem cells (UC MSCs) transplantation for patients with refractory systemic lupus erythematosus (SLE). Nine SLE patients, who were refractory to steroid and immunosuppressive drugs treatment and underwent MSCs transplantation in 2009, were enrolled. One million allogeneic UC MSCs per kilogram of body weight were infused intravenously at days 0 and 7. The possible adverse events, including immediately after MSCs infusions, as well as the long-term safety profiles were observed. Blood and urine routine test, liver function, electrocardiogram, chest radiography and serum levels of tumor markers, including alpha fetal protein (AFP), cancer embryo antigen (CEA), carbohydrate antigen 155 (CA155) and CA199, were assayed before and 1, 2, 4 and 6 years after MSCs transplantation. All the patients completed two times of MSCs infusions. One patient had mild dizzy and warm sensation 5 min after MSCs infusion, and the symptoms disappeared quickly. No other adverse event, including fluster, headache, nausea or vomit, was observed. There was no change in peripheral white blood cell count, red blood cell count and platelet number in these patients after followed up for 6 years. Liver functional analysis showed that serum alanine aminotransferase, glutamic-oxalacetic transaminase, total bilirubin and direct bilirubin remained in normal range after MSCs infusions. No newly onset abnormality was detected on electrocardiogram and chest radiography. Moreover, we found no rise of serum tumor markers, including AFP, CEA, CA125 and CA199, before and 6 years after MSCs infusions. Our long-term observational study demonstrated a good safety profile of allogeneic UC MSCs in SLE patients.

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“…157 This confirms that the use of hUCMSCs is thus safe and no tumorrelated effects occur. 157 A study with allogeneic hUCMSCs in an osteoarthritic patient showed regeneration of cartilage without adverse effects up to 7 years of follow up. 158 Allogenic cord blood stem cell transplantation was also successfully used in babies with severe combined immunodeficiency syndrome and led to a reconstitution of hematopoietic cells.…”

“…A 6‐year follow‐up study also demonstrated the long‐term safety profile of hUCMSCs infusion for drug‐resistant systemic lupus erythematosus patients. The treatment reduced the disease activity significantly . This confirms that the use of hUCMSCs is thus safe and no tumor‐related effects occur .…”

“…The treatment reduced the disease activity significantly . This confirms that the use of hUCMSCs is thus safe and no tumor‐related effects occur . A study with allogeneic hUCMSCs in an osteoarthritic patient showed regeneration of cartilage without adverse effects up to 7 years of follow up .…”

“…These stem cells can differentiate into the required cell types and secrete regenerative factors . hUCMSCs are save for use in children and adults . while no immunogenic rejection was observed after allogeneic transplantation .…”

“…143,145,146 hUCMSCs are save for use in children and adults. [154][155][156][157] while no immunogenic rejection was observed after allogeneic transplantation. 152,153 The low immunogenicity of hUCMSCs would also allow the use of hUCMSCs from a central cord blood stem cell bank when autologous stem cells are not available.…”