Patients who received intradiscal injections of SpinalCyte's new cell-based therapy CybroCell showed significantly improved disc height after six months.
Here are six things to know.
1. CybroCell is the first off-the-shelf allogeneic human dermal fibroblast product for the treatment of degenerative disc disease.
2. The Phase 1/Phase 2 clinical trial is still enrolling and includes 24 patients with chronic lower back pain due to degenerative disc disease. The patients are randomly assigned to one of three groups and receive intradiscal injections in one to three discs. The first group receives a saline-only placebo, the second group receives 10 million HDFs and the third group receives 10 million HDFs and platelet-rich plasma.
3. Preliminary six-month MRI data has been completed on 18 patients. Patients who received CybroCell or CybroCell with PRP had better outcomes compared to the control group: 83 percent of CybroCell patients had increased disc height or no change in one or more discs compared to 66 percent of patients in the control group.
4. More than half — 52 percent — of CybroCell-treated discs had either increased disc height or no change compared to 38 percent of the control group.
5. According to SpinalCyte CEO Pete O'Heeron, CybroCell has the potential to eliminate the need for opioid use in chronic back pain patients.
6. SpinalCyte is funded entirely by angel investors.
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