FDA Approves Cell Transplant Research on Spinal Cord Patients

The FDA has given approval to the Miami Project to Cure Paralysis to start groundbreaking clinical trials studying the effects of human cell transplants on people with spinal cord injuries.

The center’s leading researchers believe that this is a first step toward curing paralysis and may lead to medical advancements that could someday treat neurological conditions such as Alzheimer’s or Parkinson’s disease.

“We feel like this is our Olympic moment. We feel like we have won the gold,” said W. Dalton Dietrich, the center’s scientific director.

Schwann cells, found in the peripheral nervous system and essential for sending electrical signals, will be taken from recently injured patients, grown in culture for several weeks, then surgically transplanted into the participants’ spinal cords. The center’s team thinks the cells may reinsulate the damaged spinal nerves.

Researchers said the stage one trial must focus on demonstrating safety and will not reverse paralysis. Preliminary studies on several animal species were required for FDA approval on human subjects, a process that took years and a 1,500-page application.

The Miami Project to Cure Paralysis center, based at the University of Miami Miller School of Medicine, will begin recruiting eight patients as soon as the trial is approved by the university’s Institutional Review Boards.

Subjects must have suffered thoracic spinal cord injuries within five days of agreeing to participate, be between 18 and 50 years old, and have a specific level of paralysis.

Schwann cell transplants are not the same as stem cell therapies. Schwann cells are taken from the patients’ own bodies reducing the risk of rejection.

 

USDA: Food Prices Will Rise 3 to 4% Next Year

According to the U.S. Dept. of Agriculture the record drought that half the country suffered through will eventually push food prices up by 3 to 4 percent next year.

Milk, eggs, beef, poultry and pork prices will all be affected due to higher prices for feed. Beef prices are expected to see the biggest jump at 4 percent to 5 percent. Dairy product prices 3.5 percent to 4.5 percent; poultry and egg prices are projected to rise 3 percent to 4 percent; and pork prices are expected to rise 2.5 percent to 3.5 percent in 2013.

“In 2013 as a result of this drought we are looking at above-normal food price inflation. … Consumers are certainly going to feel it,” USDA economist Richard Volpe said.

Normal grocery price inflation is about 2.8 percent.

Volpe said the drought is not expected to affect prices for fruits and vegetables. Most of those crops are irrigated.

“This drought was a surprise for everybody,” he added. “The USDA was forecasting a record year for the corn crop until this drought materialized. Now we’re not going to get that.”

Poultry prices will be the first to rise because of the drought because chickens and turkeys need only a few months to grow to market size, he said. Meat and poultry prices are the most affected because feed prices represent the biggest part of their cost of production. Processed food prices are less affected by changes in commodity prices because ingredients typically make up just a fraction of their production costs.