Fifteen Colorado Men Will Head To Bed To Advance CU-Boulder Space Research

July 17, 2006

The University of Colorado at Boulder will send a group of volunteers to bed for 10 days in the name of science in an effort to understand and treat muscle atrophy, a malady that affects all astronauts and millions of earthbound people.

The BioServe Space Technologies Center in CU's aerospace engineering sciences department will begin a Phase 1 clinical trial in early August, looking at the effects of a new experimental drug to mitigate muscle degeneration in 15 healthy adult males, said BioServe Director Louis Stodieck. The trial builds on a 2005 BioServe study of 10 men who remained prone for 10 days -- even for showers and bathroom breaks -- so researchers could chart molecular changes in their muscle tissue and better understand cellular pathways associated with muscle disuse.

The goal is to develop a safe and effective pharmaceutical to treat astronauts and people suffering from certain types of muscular dystrophy, as well as sufferers of a muscle-wasting condition known as cachexia, which is associated with cancer, AIDS and the normal aging process, he said. "We are interested in the safety and tolerability of this experimental drug, as well as its effectiveness."

Stodieck said astronauts can lose significant muscle mass and 30 percent or more of their back and leg muscle strength in a month of weightlessness in space.

During the 19-day trial, researchers will conduct strength tests on the subjects and "slice-by-slice" MRI imaging of their quadriceps muscles. The subjects also will undergo tests to measure changes in certain key proteins known to regulate muscle growth.

The subjects will undergo several small needle biopsies in their thighs during the trial to chart muscle loss, he said. Some participants will receive a placebo while others will receive the new experimental drug developed by a private pharmaceutical company, which also is a BioServe industry sponsor. The U.S. Food and Drug Administration will evaluate results from the clinical trial, Stodieck said.

Sarcopenia, or muscle-wasting disease, often goes hand-in-hand with osteoporosis, and "one can make the other worse," he said. "Weaker muscles can make people more likely to fall, and elderly people bedridden from falls and related bone fractures experience additional muscle atrophy," Stodieck said. During space flight, astronauts lose bone mass as well as muscle mass, he said.

As in 2005, the new study will take place in the General Clinical Research Center in the University of Colorado Hospital at the CU Health Sciences Center in Denver. The subjects -- who will be between the ages of 18 and 45 -- will spend their days reading, chatting, watching videos and surfing the Internet.

The research subjects will be paid an undisclosed sum of money for participating in the study, said Stodieck, who is an associate professor of research in the aerospace engineering sciences department.

Currently, astronauts on the International Space Station spend two to three hours a day exercising in an attempt to mitigate muscle atrophy in a low-gravity environment, Stodieck said. "On an extended spaceflight mission to Mars, for example, muscle atrophy could make astronauts less fit to perform tasks in space."

The study is funded in part by NASA and the National Institutes of Health.

Founded in 1987, BioServe works with a number of industrial partnerships and is one of 11 NASA Research Partnership Centers in the United States promoting the commercial development of space. Faculty, staff and students at BioServe have designed, built and flown 35 life sciences and biomedical research payloads on 24 space shuttle flights and on International Space Station missions.

BioServe is slated to fly payloads on three of the next four NASA space shuttle missions beginning in late August, he said. Stodieck said the center hopes to fly a space shuttle experiment in 2007 involving mice to investigate new pharmaceuticals to treat muscle-wasting conditions.

For more information on participation in the volunteer trial, contact BioServe research study coordinator Stefanie Countryman at (303) 735-5308.

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