SpinalCyte applies to expand CybroCell Human Dermal Fibroblast clinical trial: 5 key insights

Written by Shayna Korol | April 13, 2018 | Print  | Email

SpinalCyte 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.

Here are five things to know.

1. SpinalCyte's Phase 1/Phase 2 clinical trial is still enrolling. Currently, it 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.

2. According to preliminary six-month MRI imaging data:

3. Over 50 percent of CybroCell-treated patients reported significant therapeutic improvement.

4. According to SpinalCyte CEO Pete O'Heeron, CybroCell has the potential to eliminate the need for opioid use in chronic back pain patients.

5. The Phase 1/Phase 2 clinical trial is the first allogeneic use of fibroblasts outside of dermatological conditions.

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