Bye-bye bandages? New technology heals wounds using patient's own blood

Each year, an alarming 15 to 25 percent of the diabetic population—equivalent to a staggering 1.5 million individuals—suffers from diabetic wounds, such as ulcers, costing the U.S. government and economy billions annually. 

US-based medical device company, RedDress has now entered the market with its proprietary blood-based technology. What sets this innovation apart is its ability to create an in-vitro blood clot from the patient's own whole blood in real-time. The establishment claims its technique has almost zero risk of rejection and is cost-effective.

To explore how this novel technology is breathing new life into chronic wound management, Interesting Engineering (IE) connected with RedDress' CEO and Co-founder, Alon Kushnir.

ActiGraft technology for chronic wound healing

"We have developed a technology that uses a patient's own whole blood to create, in real-time an external blood clot," Kushnir told IE. "[It] can be applied to wounds that are chronic or complex to trick the body into jump-starting the healing process."

Kushnir pointed out that blood clots tend to be viewed negatively by most people, as they are unsightly. However, from a scientific standpoint, blood clots are vital in the body's natural healing process. 

Take the scenario of a child falling off a bike and getting a scrape on their elbow or knee. In this case, the body promptly initiates the formation of a blood clot, the nearby blood vessels constrict to help prevent blood loss, and platelets arrive to seal the blood vessels, lastly, the platelets react with clotting factors to form a fibrin clot.

The clot's primary function is to halt the bleeding, prevent bacteria from entering the wound and lay the foundation for the wound's repair while signaling to the body that there is an injury in that area.

"Our technology is re-creating the body's natural healing process for patients whose bodies are unable to heal their own wounds," he stated. "This includes patients suffering from diabetic wounds on the lower parts of their bodies, or venous ulcers, and pressure injuries. "

He noted the procedure can be performed at the point of care in about 20 minutes, making it a fast, effective, and affordable solution for patients. 

The technology is called 'ActiGraft' and, according to Kushnir, can be applied weekly to chronic wounds. "The whole blood clot contains an all-fibrin structure required for cell signaling, and the whole blood retains all the cells required in the wound healing process," he explained.

He also mentioned that ActiGraft has achieved a 72 percent rate of complete wound closure at the 12-week mark. In comparison, the standard method of care only achieves a 22 percent rate of complete wound closure.

The 72 percent success rate was determined through a pilot study that focused on the safety and effectiveness of the blood clot product in treating chronic neuropathic diabetic foot ulcers (DFUs).

Participants in the study were selected from among patients visiting a wound care clinic with DFUs. A small amount of blood, around 10 milliliters, was taken from each participant and injected into the clotting tray of the product. Within just 12 minutes, the blood clot product was formed and was then applied to the specific DFU of each participant. The area was then covered with primary and secondary dressings.

Throughout the study, patients received multiple applications of the blood clot product, ranging from 5 to 9 days apart, for up to 12 weeks. This allowed for a thorough evaluation of the product's efficacy.

By the end of the study, the remarkable 72 percent rate of complete wound healing was observed, showcasing the product's potential in effectively treating chronic neuropathic diabetic foot ulcers.

A father's inspiration: from burns to chronic wounds

"The origin for the idea and ultimately for the company came from my father, who is a physician and a co-founder of RedDress," revealed Kushnir.

"He wanted to see if he could treat burns using blood clots from donated blood, so we started to play around with the technology of coagulating blood," he added. He explained this enabled them to figure out an optimal way to coagulate blood and control the entire coagulation process. 

"The idea was to take blood clots and place them over large burns to reduce infection and reduce pain. Although our first patent was for using blood clots to treat burns, this patent never became a product, as we shifted very early in the development process to treating chronic wounds instead," he said.

"I have experience in trauma patients and wound care and wanted to look at how we could use this same approach for healing complex and chronic wounds related to diabetes, for example."

Kushnir explained he worked with a few patients and learned how to find the right product using the patient's blood to regenerate the healing process.

"The technology was developed in-house, and my father, at 78, is still the medical director as we continue to figure out new ideas in our lab to treat other conditions," he said. 

ActiGraft's diverse applications and regenerative medicine potential

Kushnir clarified that ActiGraft received FDA clearance and the CE mark (certifying a product meets EU safety, health, or environmental requirements) in 2020. These approvals allowed for the use of the technology in treating various types of wounds, including leg ulcers, pressure injuries, diabetic ulcers, and surgical wounds.

"We are seeing some very promising results from our wound care approach. We published data that shows that we can grow new tissue over exposed bone, and we have not seen any other technology that has published similar data," he highlighted. 

"We are seeing more and more indications from actual cases and patient feedback that we can save legs from amputation, thus saving lives." 

"We also have ongoing clinical trials in the U.S. for treating anal fistula in Crohn's and inflammatory bowel disease (IBS) patients, with very promising data gathered in a completed trial in Israel," he added.

Additionally, Kushnir revealed his team is also working on supporting nerve healing - creating nerve cells in-vivo wherever it's needed. They will be publishing results from pre-clinical trials soon. 

"This is the larger vision behind what we are doing. Regenerative medicine is the future of the human healing process, and we are excited by what we are finding in our research and development."

When discussing the limitations and challenges of blood-based technology, Kushnir pointed out that ActiGraft is commercially available for treating chronic wounds.

Additionally, he emphasized the team's ongoing efforts to conduct further clinical research on various indications, such as fistulas, pilonidal cysts, and stomas. 

"These wounds can be very challenging to heal, and ActiGraft's technology offers a proven solution for patients where very few options exist today," he concluded.