Pamisel, Phase 1 Clinical Trial Approval for Allogeneic Cell Therapy in Chronic Kidney Disease

[Asia Economy Reporter Hyungsoo Park] Pharmicell announced on the 29th that it has received approval from the Ministry of Food and Drug Safety for Phase 1 clinical trials of the chronic kidney disease treatment ‘Cellgram-CKD’.

The clinical trial will be conducted at Seoul Asan Medical Center with 10 patients diagnosed with chronic kidney disease. It will evaluate the safety of cell transplantation therapy using allogeneic bone marrow-derived mesenchymal stem cells.

Existing treatments for kidney disease can delay chronic kidney disease but have limitations in stopping its progression. The number of end-stage renal disease patients requiring renal replacement therapies such as kidney transplantation or hemodialysis is increasing annually in Korea, reaching approximately 100,000.

Mesenchymal stem cells are known to inhibit apoptosis and promote proliferation of renal tubular cells by regulating inflammation, immune responses, and angiogenesis. They improve kidney function by reducing renal fibrosis and are expected to fundamentally improve renal function.

A company official explained, "We have expanded our pipeline from autologous stem cell therapies to allogeneic stem cells," adding, "The allogeneic stem cell therapy Cellgram-CKD uses stem cells from healthy donors without requiring bone marrow extraction from the patients themselves, making it more accessible to patients." He continued, "Mass production is also possible, which can reduce costs," and stated, "We plan to accelerate development to expand marketability."

The preclinical and Phase 1 clinical trials of Cellgram-CKD are being conducted under the Advanced Medical Technology Development Project supported by the Ministry of Health and Welfare and the Korea Health Industry Development Institute.