Immune modulation therapy, latest treatment for people with chronic heart failure

Jun 29 2004

Here is the latest treatment for people with chronic heart failure: a nurse draws blood from the patient, runs that blood through a machine, superheating and “stressing” the blood, and then, injects it back into the patient.

It sounds like science fiction – and too simple to be true. But that is exactly what cardiologists at the University of Calgary Faculty of Medicine are doing in a clinical trial launched today.

The ACCLAIM study is a double-blind, Phase 3 clinical trial enrolling 2000 people with chronic heart failure across North America. Clinical research sites include Sacramento, Montreal, Dallas, Cleveland, Boston, and Calgary.

“We cardiologists have recently come to understand that inflammation plays a pivotal role in the development and progression of heart failure,” says Dr. Debra Isaac, associate clinical professor of cardiology, U of C Faculty of Medicine. “This procedure targets chronic inflammation by kick-starting the immune system’s own anti-inflammatory response.”

The procedure, known as immune modulation therapy, involves the following: a nurse takes 10 cc’s (about 2 teaspoons) of blood from a patient, and puts that blood into a specialized machine that applies stresses: heat, oxidation, and UV light. When white blood cells experience this stress, they begin to die. The nurse then re-injects that blood back into the patient’s leg muscle. The dying cells trigger an anti-inflammatory reaction in the patient, inducing his/her body to boost its own anti-inflammatory processes.

“It is critical that we slow down the inflammatory process that is toxic to the heart,” says Dr. Jean Rouleau, dean, Faculty of Medicine, Université de Montréal, and principal investigator of the study for Canada. “Our hope is that this potential treatment can alleviate the serious side-effects of chronic heart failure, and treat the long-term damage being caused by the disease.”

Phase 2 clinical trials found that this procedure was beneficial to a significant number of patients, resulting in fewer hospitalizations, better quality of life, improved clinical status, and fewer deaths due to the devastating effects of heart failure.

Dr. Isaac, principal investigator of ACCLAIM in Calgary, and director, cardiac transplantation program, Calgary Health Region, is aiming to recruit 30 people who will undergo the 20-minute procedure on an outpatient basis once a month for 2 years.