Shenzhen Beike Bio-Technology Co., Ltd. has launched a Phase I/II clinical study evaluating human umbilical cord mesenchymal stem cell (hUC-MSC) injections for the treatment of moderate to severe systemic lupus erythematosus (SLE). The study is being conducted in Shenzhen, China, and is actively recruiting participants.
SLE is a chronic autoimmune disease that can damage multiple organ systems, with current treatments often relying on immunosuppressive drugs. Many patients continue to experience significant disease activity or drug-related side effects. According to the investigators, hUC-MSC therapy is being studied as a possible way to modulate the immune system and reduce disease activity with potentially fewer long-term risks.
This randomized, quadruple-blinded, placebo-controlled trial will enroll approximately 58 adults with moderate to severe SLE. Participants are randomized into one of five groups:
- – Low dose hUC-MSCs: 1 million cells/kg, plus standard therapy
- – Medium dose hUC-MSCs: 3 million cells/kg, plus standard therapy
- – High dose hUC-MSCs: 5 million cells/kg, plus standard therapy
- – Double dose hUC-MSCs: Chosen based on phase I data (provisionally 3 million cells/kg, administered twice with a 4-week interval), plus standard therapy
- – Placebo: Placebo plus standard therapy
All participants continue their standard SLE treatments. The study uses intravenous infusion for cell or placebo administration.
The primary objective is to assess safety and tolerability, measured by the incidence and severity of treatment-emergent adverse events from day 1 to day 28 after infusion. Researchers will also record the relationship of adverse events to the study drug and analyze clinical outcomes.
The main secondary objective is to evaluate efficacy by measuring the proportion of patients whose SLEDAI-2000 score decreases by four points or more by week 24. The SLEDAI-2000 is a validated scale used to quantify lupus disease activity, with higher scores indicating more active disease.
The trial features rigorous blinding—participants, care providers, investigators, and outcomes assessors are masked to group allocation. According to the sponsor, a “double dose” group was added to examine whether repeated administration further enhances the therapeutic effect, with dosing frequency and amount to be finalized based on early results.
Investigators note in the study background that mesenchymal stem cell therapies from umbilical cord sources have shown immunomodulatory effects in preclinical and early human studies, though large, controlled trials in SLE remain limited.
The study began in June 2025 and is expected to reach primary completion in September 2027, with final study completion in December 2027. Once finished, the study will report on both safety outcomes and improvements in disease activity scores, as well as pharmacodynamics and immunogenicity data.
