University researchers have developed a new testing system that can improve care for patients who need bone marrow and stem cell transplants.
Graft-versus-host disease is a life-threatening condition that can occur in response to transplants. GVHD causes immune cells from the transplant to attack the body’s healthy tissue. In patients with diseases such as leukemia, which compromises the body’s immune system, bone marrow or stem cell transplants are necessary.
John Levine, professor of pediatrics and the study’s lead author, said in these types of cases, GVHD is a real danger.
“Following transplantation surgeries, our major concern is the development of GVHD in our patients,” Levine said. “However, it is difficult to predict the severity of GVHD at the onset of the symptoms as it varies from patient to patient.”
Prior to the research, there was no method for determining the severity of a GVHD case and whether or not it needed treatment. The treatment involves high doses of medication that reduce immune activity, so doctors must be extremely cautious when treating GVHD. Levine and his co-investigators assessed nearly 800 patients and created a scoring system that uses three proteins to assess the severity of each case of the disease.
“We found out that it was not one protein but a combination of three recently validated biomarkers TNFR1, ST2, and Reg3α,” Levine said. “We then formulated an equation which computes the concentration of the biomarkers into three Ann Arbor scores. The scores are positively correlated with the amount of risk the diagnosed patient is in, so a score 1 indicates a patient with minimal risk while a patient diagnosed with a score of 3 will subjected to intensive primary therapy.”
The Ann Arbor scoring system will help ensure patients at lower risk are subjected to less aggressive treatments than patients at higher risk. Patients will then gain individualized treatments based on their needs.
More than half of the patients undergoing bone marrow transplantation develop GVHD. Though the degree of severity differs in patients, the disease is highly lethal if not treated immediately.
The research began in the late 1990s when investigators analyzed blood samples from 500 GVHD patients. The results were verified when another 300 patient blood samples from across the United States were analyzed.
The next step, according to Levine, is the launch of a clinical trial. The U.S. Food and Drug Administration has approved this step.
“It is still research,” Levine said. “Although the paper has been published, we are still at the investigational phase. No marketing is being done yet.”