Patients with blood cancers who are undergoing stem cell transplants may benefit from the novel therapy of human milk, according to preliminary findings from a phase 2a trial.
A patient in the trial led by City of Hope who is undergoing allogeneic hematopoietic stem cell therapy was the first to receive human milk-based therapy, a news release reported. According to the National Cancer Institute, allogeneic hematopoietic stem cell therapy is a procedure in which a patient receives healthy stem cells from a matched donor who is genetically similar.
The phase 2a trial aims to analyze the usefulness, effectiveness and safety of orally receiving PBCLN-010, which are human milk oligosaccharides (HMOs, a type of carbohydrate), in combination with PBCLN-014 (B. infantis), a type of bacteria that is found in the gut of nursing infants, in this patient population.
“Previous clinical trials of PBCLN-010 (plus) PBCLN-014 have shown that it can safely and predictably control the gut microbiome in healthy adults,” Greg McKenzie, vice president of product innovation at Prolacta Bioscience, said in the news release. “Stem cell transplant patients endure extreme health challenges, and we believe this therapy may provide a positive impact with safe, effective microbiome restoration, which could help improve outcomes of these critically ill patients.”
According to the news release, the trial will also evaluate the way B. infantis is absorbed in the gut microbiome, any microbiome changes across six months and how this therapy differs from standard-of-care.
“Patients undergoing stem cell transplant often have disruptions in their gut microbiome, including an increase in potentially disease-causing pathogens and an overall loss of diversity,” said Dr. Karamjeet Sandhu, an assistant professor in the department of hematology and hematopoietic cell transplantation at City of Hope. “This leaves patients prone to opportunistic infections and graft-versus-host disease, which can result in multi-organ attack and death. This Phase 2a study will measure how well the human milk-based therapy helps establish a healthy microbiome in patients with blood cancers like it does naturally in the newborn gut.”
The respective phase 2a trial was a continuation based on findings from two previous clinical trials published in the journal Cell Host & Microbe which also analyzed the benefits of receiving human milk-based microbiome therapy.
One study from Cell Host & Microbe included cohorts that treated with HMOs and B. infantis individually and combined to see which was more beneficial for patients. The researchers collected stool samples to evaluate activity from the gut microbiome.
From the results of this study, the researchers established that the dose of HMOs after a dose of B. infantis showed higher levels of engraftment (growth of healthy bacteria in the gut microbiome after therapy) in the patient population.
The researchers of the study also determined that no patients experienced any serious side effects with this combination therapy, which demonstrated its safety. Common side effects patients encountered were nausea and vomiting; one patient experienced loss of appetite and another patient experienced bacterial vaginosis.
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