When a fracture will not heal, people are typically left with two options.
One is bone grafting, the other is surgery.
A new treatment that uses gene and stem cell therapies could promise success with a less-invasive procedure.
Researchers led by a team from Cedars-Sinai Medical Center in Los Angeles, tested the therapy on laboratory animals and found that it triggered bones to regrow their own tissue.
If it is found safe in humans, the process could replace bone grafting as the gold standard treatment.
“We are just at the beginning of a revolution in orthopaedics,” Dan Gazit, co-director of the Skeletal Regeneration and Stem Cell Therapy Program in the Department of Surgery and the Cedars-Sinai Board of Governors Regenerative Medicine Institute, said in a statement.
The study was published in the journal Science Translational Medicine.
Bone grafts can result in gaps between fracture edges, and often require surgery to relocate bone from other places in the body to fill in the spaces.
Bone can come from the patient or a cadaver.
But healthy bone isn’t always available, and surgeries can lead to other complications.
A stem cell solution
The new method involves implanting a collagen matrix made up of bone-inducing genes into stem cells.
It is inserted into the gap over a two-week span. An ultrasound pulse and micro bubbles help the matrix get into the cells.
“Our method relies on the body’s own repair cells [stem cells],” Gadi Pelled, senior author, and an assistant professor of surgery at Cedars-Sinai, told Healthline. “We recruit them to the injury site and then activate them to regenerate bone in an efficient way.”
“The uniqueness of our method is that it is injectable and minimally invasive,” Pelled said.
Researchers found that the fractures were healed eight weeks after the procedure. The bone that grew into the empty space was as strong as surgical bone grafts.
“We showed that our method was equivalent, in terms of fracture healing, to the use of an auto graft [bone graft obtained from the patient’s own body], which is the gold standard today,” Gazit said. “Our method does not require the harvest of bone, which often leads to prolonged pain and hospitalisation and risk of infection, and that is our advantage.”
Stem cell concerns?
Because the process uses stem cells from the patient’s body without external manipulation, it may not face many of the hurdles that other stem cell treatments come up against.
“But obviously we will need to show that our method is not toxic and is safe to use in people before it is approved for use in the clinic,” added Zulma Gazit, PhD, co-director of the Skeletal Regeneration and Stem Cell Therapy Program in the Department of Surgery and the Cedars-Sinai Board of Governors Regenerative Medicine Institute.
In cases where there are large gaps or fractures unable to heal, the method can be repeated to grow more bone.
That’s something that will need to be reproduced in additional studies, but the latest study is the first to show that this ultrasound-mediated gene delivery can be used to treat non-healing bone fractures, Pelled added.
David Forsh, an assistant professor of orthopaedics at the Icahn School of Medicine at Mount Sinai, and chief of orthopaedic trauma at Mount Sinai St. Luke’s, said the breakthrough needs to be reproduced before it goes mainstream.
Similar research has been conducted in the past, but the way this was done is something new, according to his knowledge.
“It sounds good,” Forsh told Healthline. “It’s very promising that they were able to achieve this.”