SpinalCyte is a Houston-based tissue engineering company developing a spinal nucleus replacement solution using human dermal fibroblasts.
Here are 10 things to know.
1. SpinalCyte's CybroCell is the first off-the-shelf allogeneic human dermal fibroblast product for the treatment of degenerative disc disease.
2. The company recently filed an Investigational New Drug Application with the FDA to expand its study of CybroCell Human Dermal Fibroblasts for the treatment of degenerative disc disease.
3. SpinalCyte's Phase 1/Phase 2 clinical trial is still enrolling. Currently, the trial 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.
4. According to preliminary six-month MRI imaging data, 83 percent of CybroCell patients demonstrated increased disc height or no change in one or more discs compared to only 66 percent of control patients.
5. Over 50 percent of patients treated with CybroCell reported significant therapeutic improvement.
6. SpinalCyte holds 25 U.S.- and internationally-issued patents and has filed for an additional 48 patents pending.
7. SpinalCyte CEO and founder Pete O'Heeron holds 11 patents and has 51 patents pending.
8. According to Mr. O'Heeron, CybroCell has the potential to eliminate the need for opioid use in chronic back pain patients.
9. The Phase 1/Phase 2 clinical trial is the first allogeneic use of fibroblasts outside of skin conditions.
10. SpinalCyte is funded entirely by angel investors.
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