Q: Dr. Eppley, Since you are always up on the latest cutting edge techniques I was wondering if you were aware of Biotimes Renevia scaffolding gel injectable which was created to be a 3d scaffolding to be mixed with mesechemal stem cells from fat and then injected sdubcutaneously for lipatrophy defects. Biotime has granted Stem Center in Spain to do the clinical trials last year. I am thinking of going there to get injections for the post rhinoplasty defects I have to the soft tissue on my dorsum. The Renevia is composed of a special hyaloronic acid, collagen gel, polyethelyne glycol and stablizing agents. Do you have any opinions of this new technology?
A: While in theory this type of synthetic implant sounds promising, it is inportant to remember that this is a European clinical trial. A clinical trial means that there is no yet proven effectiveness for this product’s theoretical benefits…and it is not yet clear as to what clinical indication this product will be studied in. Just because it is going to be studied unfortunately does not mean it will work…this is why it is being studied.
Renevia is a type of hydrogel that resembles the network of molecules outside the human cell membrane, known as the extracellular matrix. Injected as a liquid and combined with some type of stem cells, the hydrogel forms a tissuelike scaffold that anchors the new cells onto existing ones, allowing for more effective tissue regeneration. This is the company’s statement and it all sounds very promising but has yet to be proven to work as such in a human subject for any specific clinical problem.
While the concept of stem cells delivered by any method is always very appealing, to date none of the clinical trials conducted on them have shown convincing and consistent benefits. This does not mean they never will but it is important to temper what they theoretically could do with what they may actually do. There is predicate story from nearly 25 years ago that may or may relate to stem cells and that is growth factors. Much euphoria, enthusiasm and research was put into turning their well known benefits into clinical products. To date few such useable medical products have ever made it to market.
We are a long way off from seeing what stem cells do during natural development into a clinical product that can have such amazing tissue regenerative properties in fully developed adult tissues. For now, you would be far better off to use conventional means of dealing with dorsal rhinoplasty defects such synthetic fillers, fat injections, crushed or injected cartilage. There are all more reliable and currently available soft tissue augmentation materials in the nose that have a well established track record of success.
Dr. Barry Eppley