FDA Approves Increase in U.S. ReCell Trials

By August 10, 2016Information
What Causes Fires

ReCell is a product that captured national attention earlier this year for its use in the care of Tiara Del Rio, an Arizona woman who was severely burned in a home explosion caused by a damaged gas line. Tiara experienced second and third degree burns on her arms, legs, feet, and face. The burns were so extensive that she did not have enough healthy skin for ordinary skin grafts.

Dr. Kevin Foster, Tiara’s treating doctor at the Arizona Burn Center, turned to ReCell as means of combating this issue. ReCell takes a small amount of skin and suspends the skin cells in a liquid. The skin can then be sprayed over a much larger area and left for the skin to grow naturally. ReCell is currently going through the FDA approval process and isn’t approved for sale in the United States. But since its use to help Tiara, ReCell has received two key approvals from the FDA that are strong signs ReCell may be FDA approved within the next couple of years.

FDA Approvals

In April of this year, the FDA granted ReCell an investigation device exemption (IDE) for compassionate use. Normally, a device that hasn’t been approved by the FDA can only be used on humans during approved clinical studies. These studies require subjects to meet certain criteria and limit the method in which the device can be used. An IDE grants health care providers an exception in circumstances where a patient is suffering and no alternative treatment exists. The FDA’s approval of an IDE for ReCell means that health care providers can use ReCell without the need for a case-by-case FDA exception so long as the patient meets a few criteria. It also signals that the FDA recognizes ReCell’s potential.

In September, the FDA approved the expanded use of ReCell and broadened the eligibility requirements for trial participants. These changes allow for ReCell to be used in cases with more severe burn injuries and for children as young as five. The approval also puts ReCell onto a clear path for full FDA aproval. ReCell is already approved for marketing and sales in Australia, Canada, China, and Europe.

Potential ReCell Benefits

There are several potential benefits for burn victims if ReCell receives FDA approval. First, the procedure requires much less skin than traditional grafting. ReCell only requires healthy skin 1/80th of the size of the area to be treated. This is obviously beneficial for burn victims like Tiara whose burns cover over half of their body and who don’t have enough healthy skin for traditional skin grafts.

But the smaller amount of healthy skin required benefits smaller burns as well. Harvesting a small amount of skin is much less invasive than traditional skin grafts. This in turn reduces pain, discomfort, and healing time regardless of the burn size.

Finally, ReCell works quickly and efficiently. The process of harvesting skin cells and suspending them in the liquid solution only takes about half an hour, and once applied the skin normally grows back within five to seven days. Provided trials continue to go well, this is what the future of burn treatment could look like.

Will Walker

About Will Walker