A seven-year-old girl with aplastic anemia, a 54-year-old woman with lymphoma and a 45-year-old man with acute myeloid leukemia all walked out the doors of Jerusalem’s Hadassah Medical Center in the past several months after receiving an experimental treatment with an Israeli placenta-based cell therapy to beef up their bone marrow.
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The Israeli Health Ministry had approved each of these patients for compassionate use of Pluristem Therapeutics’ Placental eXpanded (PLX) cells because their medical conditions were grave despite conventional treatments. Though the youngest of the three patients died four months after the Pluristem therapy, the startup is still banking on the product’s potential.
“This is a real breakthrough,” said Dr. Reuven Or, Hadassah’s director of bone marrow transplantation and cancer immunology, commenting on the condition of Hana, the lymphoma patient.
“The treatment with PLX cells has saved her life and can certainly be classified as a medical miracle. The result of this unique case demonstrates that PLX cells could potentially be effective for use in cancer patients, who receive bone marrow transplantation following severe radiation and chemotherapy treatments, which severely damage their bone marrow.”
In August, the Haifa-based company applied for orphan drug status for its PLX cells with the US Food and Drug Administration for the treatment of aplastic anemia, a condition in which the marrow decreases, or stops production of blood cells.
Pluristem CEO Zami Aberman tells ISRAEL21c that the bone marrow transplant recovery and enhancement market is approximately $1 billion per year in the United States, where about 40,000 patients would be potential candidates.
“Although the FDA approval process can take years, Pluristem may receive an expedited approval process because we believe we will receive orphan drug status,” added Aberman.
Hana, now 54, was diagnosed with lymphoma in 2008 and received chemotherapy, which initially caused the disease to go into remission. But in 2011 the cancer showed up in her spinal cord, and radiation and chemotherapy treatments damaged her bone marrow.
Attempts at stem cell therapy using her own cells collected in 2009 weren’t successful, and neither were alternative treatments. With her health deteriorating rapidly, Hana qualified for compassionate use of PLX cells, administered by injection in two courses a week apart last May. Two weeks after the second course, she was released from the hospital with improving blood cell counts.
“Following the second injections, I started recovering and then I left the hospital ‘detention cell’ where I was for almost three months,” Hana relates. “I could not sleep because I was so happy. It is a miracle … going home without any treatment, it says everything.”
Earlier, PLX cells had also saved a young girl with aplastic anemia, and in September the company announced a third success at Hadassah, a man suffering from leukemia whom Or injected with the product.
Or explained that the PLX cells are unique because they do not have to be introduced directly into the bone marrow. “They can induce their effect from far away in the body. Just from an intramuscular injection, the cells will produce the hormone-like factors that can boost bone marrow function.”
How PLX cells are derived from the placenta, which would otherwise be medical waste.
It’s also significant that the cells were not from the patient herself. “We now have a solid observation that universal cells from a totally unrelated donor can be injected and induce very significant biological effects that are very beneficial,” Or said.