4 December 2018 - - The FDA has cleared US-based regenerative medicine company SpinalCyte, LLC's Investigational New Drug protocol for human trials in the US, considered to be the first IND approval for a fibroblast cell therapy in a chronic condition outside of dermatological uses, the company said.

The clearance allows SpinalCyte to begin recruiting and screening patients for the study.

This trial is to be initiated after the first production run is tested for quality and safety to meet the FDA said criteria.

The Phase 1/Phase 2 trial assessed pain and structural improvements in patients using the Oswestry Disability Index, Visual Analogue Scale and MRI scans. The data showed that 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo (p=0.0003).

More than 90% of patients in the treatment group had an over a 10-point reduction in Oswestry Disability Index, 100% had improvement in Visual Analogue Scale and over 84% had an increase or no change in disc height.

Degenerative disc disease is a condition in which a patient's spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3m procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion.

Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together.

It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

CybroCell is the first off-the-shelf allogenic human dermal fibroblast product for the treatment of degenerative disc disease.

SpinalCyte's Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated after 12 months, patients who were injected with CybroCell had sustained improvement in pain relief and increased back mobility.

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts.

Currently, SpinalCyte holds 35 US and international issued patents and has filed for an additional 41 patents pending.

SpinalCyte holds 116 US and International Patents pending and issued across a variety of disease pathways, including disc degeneration, cancer, diabetes, liver failure and heart failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy.