Pharmicell said Friday that the Ministry of Health and Welfare has decided to support the development of Cellgram-AKI’s, a stem cell therapy for acute kidney injury, phase 1 clinical trial.
Acute kidney injury is a rapid decline in kidney functions. Ischemia-reperfusion is the most common cause of the illness.
Asan Medical Center (AMC) will conduct the public, single-institution, phase I clinical trial that will evaluate the safety of hypoxic preconditioned allogeneic bone marrow-derived mesenchymal stem cell infusion in preventing acute kidney damage due to ischemia-reperfusion injury.
Pharmicell will supply allogeneic bone stem cells for the study period.
The company has recruited patients, who underwent partial resection for kidney tumors after temporarily blocking blood flow to the kidneys, for the trials.
The clinical trial is the second research conducted by Pharmicell that the government has decided to support.
In 2015, the company collaborated with AMC, with a grant from the government, to run pre-clinical trials for the treatment for kidney disease using hypoxic cultured allogeneic mesenchymal stem cells. The company secured the basis for clinical entry at the time.
The current study aims to evaluate the safety and efficacy of intrathecal injections of mesenchymal stem cells to prevent acute kidney injury and to protect its functions, according to a press release the company issued.
Patients with an ischemia-reperfusion injury in their kidney often miss the treatment period due to the lack of early recognizable biomarkers, a company official said. “This is why there is a need for a new concept of treatment due to limitations of drug or surgical treatment.”