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World Lupus Day: Lupus Erythematosus enters the era of biological therapy, and stem cells give patients new hope

World Lupus Day is celebrated on 10 May every year.

This day is set up for a special group of patients, that is, lupus erythematosus patients.

In fact, the most serious so-called "lupus" is systemic lupus erythematosus, which is a common autoimmune disease, more common in women, common in women aged 15-40 years old, clinically in addition to skin manifestations, there are organ involvement, clinically there are kidney damage manifestations accounted for 45%-85% [1].

World Lupus Day: Lupus Erythematosus enters the era of biological therapy, and stem cells give patients new hope

Over the past 20 years, research on stem cell therapy for systemic lupus erythematosus has yielded initial clinical efficacy. In China, the stem cell treatment of lupus erythematosus related projects won the Science and Technology Award, once again showing the great potential of this treatment program.

World Lupus Day: Lupus Erythematosus enters the era of biological therapy, and stem cells give patients new hope

On the occasion of World Lupus Day, we would like to introduce the latest clinical research advances in this field to help you further understand the development of stem cell therapy for systemic lupus erythematosus.

Lupus erythematosus entered the era of biological treatment

In 2021, the world's first dual-target lupus erythematosus new drug was born in the mainland, which is a "dual-target" class biological new drug, named Tetacip, which is also the first domestic dual-target class I new drug approved for listing in the mainland in 60 years. The new drug simultaneously inhibits the overexpression of both BLyS and APRIL cytokines, preventing the differentiation and maturation of abnormal B cells, thereby reducing the body's immune response.

In recent years, systemic lupus erythematosus has ushered in the era of biological therapeutic drugs. In the past 60 years, only one new biologic drug has been approved that may be used for systemic lupus erythematosus, known as belijumab. After the listing of tetacip, such patients will have more choices. Stem cell-based biological therapies have also been applied to the treatment of systemic lupus erythematosus and have made great progress.

World Lupus Day: Lupus Erythematosus enters the era of biological therapy, and stem cells give patients new hope

Mesenchymal stem cells: a new hope for a cure for lupus erythematosus

Over the past 20 years, research on stem cell therapy for systemic lupus erythematosus has yielded initial clinical efficacy.

In China, the development of stem cell treatment projects related to lupus erythematosus has made people see the great potential of this treatment solution. Professor Sun Lingyun's team project "Key Technological Innovation and Clinical Application of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory Lupus Erythematosus" won the second prize of the National Technological Invention Award. The study has overcome the worldwide problem of lupus erythematosus treatment, and the team has carried out allogeneic mesenchymal stem cell treatment of refractory lupus erythematosus, which has been promoted to 35 units inside and outside the province.

World Lupus Day: Lupus Erythematosus enters the era of biological therapy, and stem cells give patients new hope

In June 2020, the clinical trial application for a new drug for the treatment of systemic lupus erythematosus was accepted by the National Drug Evaluation Center, using perinatal tissue-derived mesenchymal stem cells. These signals give hope.

Internationally, mesenchymal stem cell therapy for systemic lupus erythematosus is also in full swing.

The University of South Carolina evaluated the efficacy and safety of cord mesenchymal stem cells in adults with systemic lupus erythematosus from 2015 to 2019, randomly assigned 81 volunteers recruited in a Phase II controlled trial, and is currently in progress [3].

In 2019, the University of South Carolina evaluated the safety of allogeneic mesenchymal stem cells in adult patients with moderate to severe systemic lupus erythematosus [5], with a total of six patients participating in the trial. Participants received a single infusion of mesenchymal stem cells (at a dose of 1×10^6 cells/kg) and continued standard treatment during the trial, which has been completed and achieved good results.

In April 2019, the UC-Los Angeles Cell Therapy Translational Research Project conducted a Phase II clinical trial to evaluate the dose response and efficacy of umbilical cord mesenchymal stromal cells in renal systemic lupus erythematosus [6]. A total of 39 volunteers were recruited to receive standard treatment for patients with severe nephropathy with systemic lupus erythematosus in the phase IIa trial, gradually increasing the dose of intravenous mesenchymal stem cell injections, followed by phase IIb.

Mesenchymal stem cells have been shown to be promising in the treatment of lupus erythematosus, and the clinical efficacy is good, which can be described as a blessing for patients with lupus erythematosus. With the progress of research, the clinical effect of stem cells in the treatment of systemic lupus erythematosus began to become significant, and it also emerged in the treatment of other autoimmune diseases. At the same time, scientists are conducting a number of clinical trials to verify the safety and efficacy of this treatment, which is expected to fundamentally change the clinical situation in the future. I believe that in the near future, there will be more lupus erythematosus patients to benefit from the efforts of scientists, the progress of science and technology, we will eventually usher in the day when we will no longer "talk about wolf discoloration".

Bibliography:

[1] Doria A, Iaccarino L, Ghirardello A, et al. Iconography: long -term prognosis and causes of death in systemic lupus erythe-matosus[J]. Am J Med, 2006, 119(8): 700-706

[3] Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)

[4] Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord (MSC-SLE)

[5] Pilot Trial of Mesenchymal Stem Cells for Systemic Lupus Erythematosus

[6] Mesenchymal Stromal Cells (MSC s) in Renal Lupus (MSC-ROLE)

World Lupus Day: Lupus Erythematosus enters the era of biological therapy, and stem cells give patients new hope

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