A Phase 1 clinical trial has investigated the effect of umbilical cord-derived MSCs on the immune systems of Lupus patients. Although the study was small, positive results were observed 24 weeks post-treatment.
During the trial at the Medical University of South Carolina, six patients with refractory Systemic Lupus Erythematosus (SLE) were given an injection of MSCs from the umbilical cord. Researchers measured how the infusion treated the patients’ immune systems. In particular, they focused on types of T-cells and B-cells that impact/hinder the immune function in Lupus sufferers.
24 weeks after treatment, the MSCs were shown to help regulate the activity of B-cells and autoimmunity. The stem cells notably reduced the number of abnormal memory B-cells and increased non-reactive B-cells in four of the six patients. In two patients, the stem cell treatment was associated with a slight increase in T-cells.
Mesenchymal stem cells (MSCs) are found in umbilical cord tissue. They can multiply to form cartilage, bone and fat. This Phase 1 clinical trial suggests that an infusion of MSCs could directly benefit hard-to-treat Lupus, although a Phase 2 trial has been launched to investigate these findings further.
In the phase 2 trial, researchers will conduct a double-blind, placebo-controlled experiment - in addition to the standard care for Lupus - in 81 adults. The patients will be randomised to receive one of two MSC infusions or a placebo. To define success, researchers will look for a four-point or higher reduction in Systematic Lupus Erythematosus Disease Activity Index score (SLEDAI), as well as disease flare frequency, fatigue, pain and depression.
It is hoped that after Phase 2 has been completed, we will understand the efficacy and safety of using umbilical cord-derived MSCs to treat Lupus in the future.