3 US multi-center stem cell trials are underway – injecting cells into the disc, the annulus and the fractured vertebra
Spine Stem Cell Trials Underway (written by Bilioine Young @ OTW)
Dr. Hyun Bae, co-director of the spine fellowship program at Cedars-Sinai Spine Center, Los Angeles, was among the first surgeons to use growth factor tissue engineering for intervertebral discs and multilevel artificial disc replacements for both the lumbar and cervical spine.
Now he is deeply involved in stem cell research and believes that the appropriate patients could benefit greatly from stem cell use. “I think stem cells will make a big impact on spine care,” says Bae. “I don’t think this is some mythical soundscape that won’t work. I think in the next 10 years, stem cells will make a significant impact on our medical field.”
Bae is participating in several clinical trials for spine surgery. One involves the injection of stem cells into the disc to promote disc regeneration. The goal is to relieve the patient’s pain without resorting to fusion procedures. According to Bae, this has been successful in animal models and is now being used in a human trial.
In patients with an annular tear, the surgeons are using a fibrin glue to close the disc and promote healing instead of fusing it or removing it. They are injecting fibrin glue in half of the patients and a placebo in the other half to measure the glue’s efficacy. Bae is surprised with the success some patients are exhibiting. “Some of the patients have had amazing results,” he says. “I’m surprised because initially I was sceptical, but I’ve been amazed.”
A third trial is investigating the use of stem cells for treating vertebral compression fractures in patients with osteoporosis. Surgeons transport allograft stem cells to the surgical site where the cells are manipulated by non viral methods to produce a bone morphogenic protein-type molecule, which, they believe, should promote healing.
“We want the stem cells to produce a growth factor that can also stimulate healing,” says Bae. “We’ve shown in animal models that we can insert a gene into the cells that will be able to produce bone. We can heal a radial, vertebral body or long bone defect by injecting stem cells into the surgical site that have been modified to produce bone.”
Bae hopes to research this method with patients who have osteoporosis. While these patients have global bone loss, there are certain sites where the loss is more significant. “If we are able to inject stem cells into a damaged site like the hip joint, we may be able to prevent the major fracture morbidity associated with osteoporosis,” he says.
Cedars-Sinai is one of eight centers where surgeons are examining the use of stem cell injections for disc regeneration. Most devices and procedures utilizing stem cell technology have not yet been approved by the Food and Drug Administration.