LiveKidney Enrolls First Patient in Phase I/IIa Clinical Trial to Assess LK-SC001 for Treatment of Lupus

U.S. Study Assessing Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) Transformative Therapy to Improve Kidney Function and Reduced Disease Activity 

TEL AVIV, Israel, May 6, 2025 /PRNewswire/ — LIVEKIDNEY.BIO (LiveKidney), a clinical-stage biotech company developing cell-based therapies for kidney diseases, announced today that it has enrolled its first patient in a Phase I/IIa study of LK-SC001, a proprietary formulation of UC-MSCs designed to improve kidney function for lupus nephritis patients.

The open label trial (NCT06737380), which is being conducted at the Medical University of South Carolina (MUSC), aims to evaluate the safety, tolerability and efficacy of LK-SC001, a subcutaneously formulated UC-MSCs therapy, as a treatment for lupus nephritis and active systemic lupus erythematosus (SLE). This first-in-human clinical trial seeks to establish that UC-MSCs can improve kidney function and control lupus activity.

“There is a real unmet medical need for innovative, safe and effective treatment for lupus nephritis patients,” said Dr. Alon Yaar, CEO of LiveKidney. “The recruitment of the first patient marks a significant milestone for our company and can bring hope to millions of lupus patients worldwide. LK-SC001 enables the release of bioactive and immunomodulatory compounds, helping to regulate the immune system and to reduce deterioration of kidney function. Our pipeline of future products is based on our proprietary delivery platform and is designed to address a wide range of kidney-related diseases.”

“Current standard of care treatment for lupus is limited and effective in only 40% of patients. These therapies do not adequately address the complex immunological nature of the disease,” said Gary Gilkeson, MD, Professor of Medicine and Associate Dean for Faculty Affairs and Faculty Development at MUSC. “LK-SC001 offers a new approach designed to improve kidney function and reduce inflammation, addressing a critical gap in current treatment options for affected patients.”

About LIVEKIDNEY.BIO

LiveKidney is a clinical-stage biotech company that is developing proprietary, pharmaceutical-grade hydrogel-based formulations of Umbilical Cord-derived Mesenchymal Stromal Cells (UC-MSCs) to treat advanced kidney disease and prevent its progression towards kidney failure. The company’s products allow the continuous release of bioactive compounds from the UC-MSCs to the kidneys via unique routes of administration, triggering anti-inflammatory and anti-fibrotic effects. With offices in New York and Tel Aviv, LiveKidney’s delivery platform aims to transform the treatment paradigm for millions of metabolic syndrome and autoimmune patients living with kidney-related diseases.

For more information, visit https://livekidney.bio/ and follow LiveKidney on LinkedIn.

Media Contact:

Ellie Hanson
FINN Partners for LiveKidney
ellie.hanson@finnpartners.com 

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SOURCE LIVEKIDNEY.BIO