Pamicell "Obtains Approval for Use of Stem Cells for COVID-19 Treatment"

[Asia Economy Reporter Hyungsoo Park] Pharmicell announced on the 30th that the Ministry of Food and Drug Safety of Korea approved the use of the allogeneic mesenchymal stem cell therapy Cellgram-AKI for emergency treatment support of the novel coronavirus infection (COVID-19).

A company official stated, "We applied for approval for therapeutic use from the Ministry of Food and Drug Safety on the 9th to provide stem cell therapy benefits to severe COVID-19 patients."

He added, "Cellgram-AKI confirmed safety during Phase 1 clinical trials at Seoul Asan Medical Center. It is expected to help prevent symptom aggravation caused by the cytokine storm seen in COVID-19 patients through the anti-inflammatory action of stem cells."

The official also noted, "Cellgram-AKI, an allogeneic stem cell therapy, has the advantage of being quickly administered to patients after prescription."

Pharmicell plans to intravenously administer Cellgram-AKI to numerous COVID-19 patients at Yonsei University Wonju Severance Christian Hospital and other locations. Cellgram-AKI is originally an allogeneic mesenchymal stem cell therapy designed to prevent acute kidney injury. Mesenchymal stem cells exert cell regeneration and immunoregulatory abilities, inducing a strong systemic anti-inflammatory response. It may also be effective in treating COVID-19.

Severe pneumonia (ARDS) caused by cytokine storms resulting from heterologous infections occurs due to unpredictable pandemics (global outbreaks). Conventional clinical trial procedures cannot be followed, and Pharmicell plans to treat patients by submitting a therapeutic use plan with the prepared allogeneic stem cell therapy.

Recently, China has published numerous clinical results and papers reporting successful treatment of COVID-19 patients using mesenchymal stem cells. In particular, the international academic journal Aging and Disease introduced that mesenchymal stem cells improved lung function in COVID-19 patients within 2 days through immunoregulatory capabilities. Among 7 patients, 2 general patients and 1 severe patient recovered within 10 days.