Israeli and American doctors are collaborating on a new non-invasive procedure to treat sufferers of emphysema. Emphysema is a terrible disease for which there is no cure.
Until now, the only way to treat the terrible symptoms of the disease was through high-risk major surgery. But a new technique that is being fully tested for the first time at the Sheba Medical Center at Tel Hashomer may point to a non-surgical and less dangerous alternative.
When emphysema strikes, lung tissue loses its elasticity, and airways become obstructed. For patients, it means great difficulty breathing and generally impaired functioning in their entire body, as the exchange of oxygen and carbon dioxide is disturbed. It is an irreversible process: once lung cells are affected, there is no way to rehabilitate them.
Over 3.1 million Americans have been diagnosed with emphysema, and its aftermath: chronic obstructive pulmonary disease (COPD), which is the fourth-highest cause of death in the US.
In more than 80 percent of the cases, emphysema occurs as the result of smoking.
Like all pulmonary physicians, Dr. Alon Yellin, Chief of General Thoracic Surgery at Sheba Medical Center in Ramat Gan and his colleagues have been continually looking for a way to help their emphysema patients after their disease advances past the stage that medication alone can alleviate their discomfort – surgically or otherwise.
“In recent years, it became clear to us that the trend in treating emphysema, as with other diseases, would have to shift from surgery, which carries high risks, to treatments that were not invasive. Surgery will always be an option, but another solution also had to be found,” Yellin told Israel 21c.
Until a decade ago, managing emphysema meant medication – and in its most severe stages – a full lung transplant. For the past ten years, there has been another alternative – lung volume reduction surgery: a surgical procedure in which the most severely diseased portions of the lung are removed to allow the remaining lung and breathing muscles to work better. While the results have been promising, the risks involved in this procedure are considered unacceptably high for patients who are in an already weakened condition from the effects of the disease.
“The operation requires a long hospitalization. In the best-case scenarios, approximately five percent of the patients die and in the worst case – 10 percent,” Yellin explained. “This is what has reduced the enthusiasm for the procedure between when it first came on the scene and now.”
Several years ago, Yellin came upon an article that fascinated him describing a start-up in Boston, which was conducting experiments treating emphysema in sheep, in connection with the Tufts Veterinary School.
“What they were doing mimicked the lung volume reduction surgery but in a non-surgical way,” said Yellin.
The technique involved injecting the lungs with material described as “biological glue” which completely destroyed the cell connections in the damaged portions and “sealed them up,” combined with antibiotics to prevent infection. In the sheep, the damaged lung areas collapsed and scarred, leaving only the healthier, better-functioning parts of the lung intact – the technique essentially reduced the lungs without surgery.
Shortly afterwards, a member of Yellin’s department, Dr. Yael Raffaeli, traveled to Boston to do training at Brigham and Women’s Hospital, where the staff included the doctor who developed the technique used on the sheep.
“Through my colleague, we contacted him and suggested that when the technique was ready for human clinical trials, we would test it together at the same time in Israel,” he said.
They met with enthusiasm on the American side and set up their collaboration. After getting the approval of the Israeli Health Ministry to participate – a laborious process which took more than a year, the trials began last month. After the technique was tried on hundreds of sheep, the time had come to test it on human beings, both in the US and in Israel.
While the US trials and the Israeli trials are taking place simultaneously, they are of a different nature. The FDA gave the Boston hospital permission to conduct a Phase One study to check safety of the technique. Therefore, the 12 patients will have only two sections of their lung treated.
The Israeli hospital is authorized for a full-fledged treatment in which it may inject the lungs in all 10 sites, testing not only safety but effectiveness.
So far, six patients have begun treatment in Boston and four in Tel Aviv.
Yellin is cautious about drawing conclusions in this early stage but “it has gone better than we anticipated.”
Finding patients who volunteered for the procedure was “surprisingly not difficult,” he reported. “It seemed everyone wanted to volunteer and be first.”
He said that the relationship between the American and Israeli investigators had become “very close” with a considerable amount of travel back and forth. “The American doctors came here to make sure that we were doing it the right way in a top-level facility. It is very exciting for me knowing that we are the only two places in the world doing this procedure right now.”
Both sides are being very carefully monitored by their government health authorities.
“Israel has been just as strict and difficult as the United States, and I think it’s a good thing. When you are doing something new, there is nothing wrong with many precautions and restrictions that require you to take things step by step,” Yellin said.
Yellin, who lives in Tel Aviv, received his medical training at the Hebrew University in Jerusalem and trained for two additional years in Los Angeles at the City of Hope Medical Center. He is an Associate Professor of Surgery at Tel Aviv University.
Assuming the trials go well, he believes the treatment will become popular quickly.
“We know the trend in medicine is towards minimal invasive surgery or no surgery at all. If you can achieve the same results without surgery, why put your patient through the trauma and risk? If this works and it seems to be working there will be tens of thousands of patients all over the world treated with the technique we are pioneering now.”