EHL Bio Receives IND Approval for Phase 1 Clinical Trial of Stem Cell Therapy in Korea

HL Bio announced on the 15th that it has received approval from the Ministry of Food and Drug Safety for the Phase 1 clinical trial plan (IND) of KDStemju, an autologous urine-derived stem cell therapy.

This clinical trial is conducted to evaluate the safety, tolerability, and exploratory efficacy of KDStemju, a stem cell therapy, in patients with chronic kidney disease. The clinical trial will take place in South Korea, and the first patient is scheduled to be administered the treatment in the second half of 2023, according to company officials.

KDStemju is a cell therapy product manufactured by collecting stem cells from the patient's own urine, followed by isolation and cultivation processes. It has the advantage of being non-invasive due to the ease of collection from urine. Additionally, compared to typical stem cells isolated from fat, bone marrow, or umbilical cord, urine-derived stem cells are expected to be beneficial in treating intractable kidney diseases as they originate from the kidney.

In animal models of chronic kidney disease, KDStemju demonstrated that Kloso, a kidney-specific key therapeutic factor secreted from urine-derived stem cells, effectively inhibited the progression of renal fibrosis. It was also confirmed to promote regeneration of damaged kidney tissue.

HL Bio CEO Lee Hong-gi stated, “One in five adults over 50 in South Korea suffers from chronic kidney disease,” and added, “We expect KDStemju to show good effects on chronic kidney disease, and we will do our best to achieve positive results.”

Meanwhile, HL Bio is equipped with GMP facilities, enabling the safe and verified production and supply of clinical trial drugs. In January, the Phase 2 clinical trial of ADStemju, a treatment for atopic dermatitis, was completed.