Positive clinical trial results for human dermal fibroblast injection CybroCell: 7 key insights

Shayna Korol -   Print  |

Houston-based regenerative medicine company SpinalCyte completed the first double-blind, placebo-controlled human trial using CybroCell, a human dermal fibroblast injection to treat degenerative disc disease.

Here are seven things to know:


1. Nearly 70 percent of patients treated with CybroCell, the first off-the-shelf allogeneic HDF product for treating degenerative disc disease, reported significant clinical improvement.


2. Previous research demonstrated that intradiscal CybroCell injection led to significant increase in regeneration, disc height and gene expression of structural genes such as collagen type I and collagen type II. It also led to a significant increase in the contents of structural proteins such as proteoglycan, which generate the jelly-like disc nucleus that provides cushioning for the spine.


3. The Phase 1/2 trial included 16 patients with chronic lower back pain caused by DDD. The patients were randomly assigned to one of three groups: first received a placebo in the form of saline only, the second received a single intradiscal injection of 10 million cells of CybroCell and the third received a single intradiscal injection of 10 million cells of CybroCell along with platelet-rich plasma.


4. Researchers used the Oswestry Disability Index and determined that the ODI of four of the six patients treated with CybroCell decreased by more than 15 points, constituting a significant therapeutic improvement.


5. One of the four patients treated with CybroCell in combination with platelet-rich plasma reported an ODI decrease of more than 15 points, while one of six patients in the placebo group reported an ODI decrease of more than 15 points.


6. According to SpinalCyte CEO Pete O'Heeron, CybroCell may reduce or eliminate the need for opioids among patients with chronic back pain as a result of degenerative disc disease.


7. The Phase 1/2 trial is the first allogeneic fibroblast use outside of skin conditions. Researchers believe this trial has implications for other areas of regenerative medicine considering how relatively simple it is to collect large numbers of fibroblasts. The fibroblasts used in CybroCell are cheaper to produce and acquire than stem cells, according to SpinalCyte Chief Scientific Officer Thomas Ichim, PhD.


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