Pamisel Successfully Completes Phase 1 Clinical Trial of Allogeneic Stem Cell Therapy

Safety Proven in Phase 1 Clinical Trial of Stem Cell Therapy for Chronic Kidney Disease
Same Active Ingredient as Previously Approved Autologous Stem Cell Therapy
Accelerating Development of High-Market-Value Allogeneic Therapy

Pharmicell announced on the 22nd that its stem cell therapy product manufactured from allogeneic cells, not autologous cells, ‘Cellgram-CKD’, has successfully completed Phase 1 clinical trials conducted on patients with severe chronic kidney disease.

In the Phase 1 clinical trial of Cellgram-CKD, approved by the Ministry of Food and Drug Safety in July 2021, Pharmicell administered the drug intravenously three times to 10 patients diagnosed with chronic kidney disease. During the clinical process, no serious adverse reactions related to the investigational drug occurred, and along with safety, some potential therapeutic effects were also confirmed.

Professor Kim Hyo-sang of the Department of Nephrology at Seoul Asan Medical Center, who participated in the clinical trial, explained, "Slowing the decline in kidney function in chronic kidney disease is a very challenging issue," adding, "After three administrations of Cellgram-CKD, a positive result was observed where the decrease in glomerular filtration rate slowed, thereby delaying the decline in kidney function." He further stated, "Through the administration of mesenchymal stem cells, structural and functional recovery of the kidney can be expected, including neovascularization and reduction of renal fibrosis."

Pharmicell had already commercialized the autologous stem cell therapy product ‘Haticelgram-AMi’ in 2011. With the safety of the allogeneic cell therapy product, which has the same main component of bone marrow-derived mesenchymal stem cells, being demonstrated, the development of allogeneic therapies that offer easier patient accessibility is expected to gain further momentum.

Recently, the amendment to the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals passed the National Assembly. If the safety and efficacy of a therapy are confirmed through advanced regenerative medicine clinical research, treatment plan approval can be obtained without going through the existing formal approval process. This allows the therapy to be used for patients through the advanced regenerative medicine treatment system.

Based on the successful Phase 1 clinical trial results, Pharmicell plans to conduct advanced regenerative medicine clinical research to evaluate efficacy. They are preparing promptly to enable advanced regenerative treatment for patients with chronic kidney disease.

A Pharmicell official stated, "Since the clinical research will be conducted by expanding the range of target patients, we expect that the therapy will be widely applicable to patients with kidney disease in the future."

This content was produced with the assistance of AI translation services.