The regulator has recently allowed local hospitals to use Pharmicell’s stem cell therapy for Covid-19 treatment only for another year.

With the extended approval, each medical institution’s institutional review board (IRB) can apply for the use of Pharmicell’s Cellgram-AKI, allogeneic mesenchymal stem cell therapy, for a year, Pharmicell said on Friday.

Pharmicell obtained the regulatory approval for Cellgram-AKI to treat severe pneumonia in Covid-19 patients for therapeutic purposes in March last year. The regulator gave the temporary nod for 12 months but renewed it for another year.

A researcher works at Pharmicell’s GMP Center in Seongnam, Gyeonggi Province.
A researcher works at Pharmicell’s GMP Center in Seongnam, Gyeonggi Province.

The company received the nod for therapeutic use to treat two or more patients. Accordingly, hospitals wishing to use Cellgram-AKI do not need to seek individual approval, and it can obtain approval from the hospital’s IRB.

Pharmicell said one severe Covid-19 patient received Cellgram-AKI therapy at the Severance Hospital in central Seoul in March and recovered.

Since the compassionate use of stem cell therapy was allowed in March, six Covid-19 patients were treated with Cellgram-AKI. One of them died, and the five seriously ill patients recovered, the company said.

In February, one patient at the Severance Hospital and another at Eunpyeong St. Mary’s Hospital received Cellgram-AKI. After treatment, both of the patients tested negative in PCR testing.

Pharmicell initially developed Cellgram-AKI as a stem cell treatment for acute kidney disease. However, the company thought the experimental drug’s anti-inflammatory effect could prevent cytokine storm-related symptoms from worsening in Covid-19 patients.

In particular, its stem cell therapy can help patients with significantly impaired lung function during the long-term stay in the intensive care unit (ICU) or those with multiple organ failure, the company emphasized.

However, a Pharmicell official said that the company would not conduct separate clinical tests to develop the Covid-19 treatment while leaving open the possibility of putting it into medical fields through winning approvals to use for treatment purposes. The decision took into account various factors, including commercial viability and the time needed for clinical tests.

“We will do our best to provide Cellgram-AKI for treating Covid-19,” the official added.

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