A landmark clinical trial was announced in November when a $9 million grant was provided for the first human study using stem cells to treat a spinal disorder that occurs in babies in the womb.
Becker's Spine Review expands on this clinical trial and five other stem cell notes from this year, including insights from leading spine and orthopedic surgeons.
1. The California Institute for Regenerative Medicine provided a $9 million grant to fund the first human clinical trial using stem cells to treat spina bifida. The grant was awarded to researchers at UC Davis Health in Sacramento, Calif. Beginning in 2021, the clinical trial will administer stem cells derived from placental tissue to babies in the womb to repair the defect that occurs when the protective tissue around a baby's developing spinal cord fails to fully close before birth.
2. The Steadman Philippon Research Institute in Vail, Colo., received a grant from the National Institutes of Health in August to study the use of bone marrow stem cells to delay osteoarthritis in the knee. More than $2.8 million may be awarded to SPRI as part of NIH's Regenerative Medicine Innovation Project, which aims to accelerate clinical stem cell research. Enrollment for the clinical trials will begin this fall.
3. In August, biopharmaceutical company DiscGenics raised $50 million, which it is using to fund clinical trials of its allogeneic, injectable disc cell therapy for lumbar degenerative disc disease. Discogenic Cells, biomedically engineered progenitor cells derived from human intervertebral disc tissue, are the active ingredient in IDCT. DiscGenics has secured more than $71 million in funding to date.
4. Most stem cell research is being conducted in animals, but many clinical trials have shown potential for spine surgery, according to Eeric Truumees, MD, president of the North American Spine Society. One interesting area "involves growing out cells on a scaffold and then surgically implanting the tissue into the spine," which could lead to shifts in the management of spinal cord injury and intervertebral disc regeneration, he said.
Many stem cell and regenerative medicine clinics have opened in the U.S., typically using cells from the iliac crest or platelet-rich plasma, and often as part of well-regarded spine practices, according to Dr. Truumees. While there are many testimonials about the efficacy of these products, the peer-reviewed evidence remains limited. Stem cell-based therapies may have a big future in orthopedics, but presently it's too soon to say, he said.
5. Stem cells in orthopedics and spine surgery are more hype than reality, according to Neel Anand, MD, professor of orthopedic surgery and director of spine trauma at the Cedars-Sinai Spine Center in Los Angeles. Many patients seek out these highly marketed stem cell injections, which can cost thousands of dollars out of pocket, Dr. Anand said. In an interview with Becker's, he questioned the ethical side of providing these injections, which he considers experimental, rather than therapeutic.
6. The orthopedic industry is in the midst of a stem cell bubble, which could soon burst as researchers realize there's a lot more research that needs to be done, according to Adam Anz, MD, director of the Andrews Institute Regenerative Medicine Center in Gulf Breeze, Fla. Other products such as bone marrow aspirate and PRP have shown promise for the treatment of osteoarthritis. PRP has the largest body of work to "support its use for osteoarthritis" but BMA and other products still have some work to do to prove their value, Dr. Anz said.