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6 Aug. 2020. A clinical trial testing stem cells from human placentas as a treatment for Covid-19 infections is expanding to three more sites in California. The new sites for the trial conducted by Celularity Inc., a company based in Florham Park, New Jersey, are funded by a $750,000 grant from the California Institute for Regenerative Medicine, or CIRM.
Celularity develops treatments for cancer, infectious diseases, and other disorders with blood-forming stem cells derived from donated human placenta tissue. The company’s technology extracts natural killer cells, white blood cells in the immune system with target cell-killing capabilities, then frozen and preserved. Celularity says a single placenta can generate thousands of doses, with its placenta cell products produced quickly and used off-the-shelf with no adverse immune effects, rather than cells cultured from individual patients.
The biotechnology company’s lead product, code-named CYNK-001, is already in early- and mid-stage clinical trials for blood-related cancers, multiple myeloma and acute myeloid leukemia. In January, Science & Enterprise reported on FDA authorization for an additional early-stage trial testing CYNK-001 as a treatment for glioblastoma multiforme, an aggressive brain cancer.
In April, Celularity received clearance from FDA for a clinical trial to test CYNK-001 as a treatment for Covid-19 infections. The company says its preclinical tests show natural killer cells generated from CYNK-001 activate cell-killing receptor proteins that bind to viral antigens on infected cells. Its findings also show the natural killer cells express cell-killing molecules perforin and granzymes that can stop replication of SARS-Cov-2 viruses in human cells. Celularity says these CYNK-001 properties can help infected patients block further progression of the disease and allow the body’s adaptive immune system to clear the virus.
“CYNK-001,” says Celularity chief scientist Xiaokui Zhang in a company statement, “has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection.” The company says CYNK-001 has already been used under compassionate use authorization to treat people with severe Covid-19 infections, including patients requiring ventilators, with the treatments well tolerated and associated with clinical benefits in some cases.
The company’s clinical trial is an early- and mid-stage study enrolling 86 patients hospitalized at four locations for Covid-19 infections, but showing no more than moderate symptoms. The first 14 patients receive three infusions of CYNK-001 on days 1, 4, and 7, looking mainly for adverse events, but also clearance of SARS-Cov-2 viruses and changes in lower respiratory tract symptoms.
The next 72 individuals are randomly assigned to receive three CYNK-001 infusions, three days apart, compared to patients receiving the best standard care. Participants are followed for the next 28 days looking for the time needed to clear SARS-CoV-2 viruses from the body, as well as improvement in symptoms related to lower respiratory tract infections. In the second stage, the study team is also watching for signs of adverse effects.
The $750,000 CIRM grant funds an extension of Celularity’s clinical trial to three more sites in California. The first of those locations is University of California in Irvine.
More from Science & Enterprise:
- NIH Begins Covid-19 Antibody Trials
- Trial Set for Covid-19 Antibodies in Long-Term Care
- Covid-19 Vaccines, Therapies – 3 August 2020
- Trial Testing Lymphoma Drug to Treat Covid-19
- Biotech IDs Potent Covid-19 Antibodies
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