CollPlant, an Israeli regenerative medicine company, announced on Dec 10, 2018, a successful clinical trial of its bioengineered collagen product in the treatment of Tennis Elbow.
Video animation about Collplant’s (an Israeli company that developers tissue repair products) recombinant human collagen ‘rhCollagen,’ which is produced with its proprietary plant-based genetic engineering technology
The clinical study, which was concluded in August of 2016, was published Nov 26, 2018 in the Journal of Shoulder and Elbow Surgery.
First Clinical Experience With A New Injectable Recombinant Human Collagen Scaffold Combined With Autologous Platelet-Rich Plasma For The Treatment Of Lateral Epicondylar Tendinopathy (Tennis Elbow)
“Based on positive outcomes from preclinical trials, this study is the first clinical trial of STR/PRP on tendinopathy.”
“The study enrolled 40 patients. No systemic or local severe adverse events were reported. Clinical evaluation revealed an improvement in the mean Patient-Rated Tennis Elbow Evaluation score from 64.8 before treatment and showed a 59% reduction at 6 months.”
- 28% increase in grip strength,
- 59% improvement of Patient-Rated Tennis Elbow Evaluation score,
- 68% showed improvements in tendon appearance via sonographic imaging
Farkash, Uri et al; J. of Shoulder and Elbow Surgery; doi.org/10.1016/j.jse.2018.09.007
The Clinical Trial Utilized Two Components In The Treatment
- CollPlant’s Vergenix Soft Tissue Repair (STR) Matrix, an injectable gel composed of cross-linked bioengineered recombinant human type I collagen,
- And Autologous Platelet-Rich Plasma (PRP) – which is discussed at length in this article on PRP here (basically, an injection of the patient’s own concentrated blood platelets, which are critical to the healing process, into the injured area to stimulate a new healing response.)
The intention is to form a collagen-fibrin matrix (tendons are composed of 65-80% Type 1 Collagen) that promotes cell migration and tendon tissue healing, while maintaining growth factor-containing platelets in the vicinity.
This is the very first clinical trial of this bioengineered collagen Platelet-Rich Plasma combination for tendinopathy, (in this case, Tennis Elbow) and the conclusion is that it would be a safe and effective treatment for it.
Quoting the company’s CEO:
“…this study concluded that Vergenix™STR demonstrated significant clinical improvements in patients with tennis elbow. Vergenix™STR offers a unique, and effective method to treat a wide range of tendinopathies with just a single application to initiate the healing process,”
“In the U.S. market alone, there are estimated to be over 3 million procedures annually to treat tendinopathy.”
Yehiel Tal, Chief Executive Officer, CollPlant
Press Release: Clinical Trial… Concludes Vergenix™ STR Effective for Tennis Elbow
Vergenix™STR is apparently only sold in Europe, currently, but CollPlant is working with the FDA to get approval in the United States.
The Last Stop Before “Open” Surgery?
Tennis Elbow is one of the most common injury disorders affecting as much as 3% of the general population; everyone from tennis players and golfers to auto mechanics and pool cleaners.
The standard treatments, and the medical perspective behind them, offer a rather dismal outlook, often referring to these painful tendon problems as “self-limiting conditions!”
(A cop out, if I’ve ever heard one!)
Later, patients may eventually be offered the newer, sexier Platelet Rich Plasma therapy option which, at least attempts to trigger a new healing response in the degenerating tendon tissue (at great expense, however.)
But surgery awaits a certain percentage (albeit, fortunately, a small one) of Tennis and Golfer’s Elbow sufferers, who have severe degeneration or a significant tear in their tendons.
Perhaps this cutting-edge bioengineered collagen treatment will offer a better option to those who have exhausted all other options and face the prospect of surgery, but who still wish to try and avoid it.
This new procedure is still performed by an Orthopedic Surgeon and falls under the general classification of a “Minimally-Invasive Procedure” so, is still in the realm of surgery.
And it seems to rely on the PRP process, involving the drawing and centrifuging of the patients blood, to concentrate their platelets (with their growth factors to support healing) prior to re-injecting them…
So, it’s somewhat of a hybrid procedure.
Personally, though. I would hesitate to have anything foreign injected into my body that I don’t absolutely need to survive – especially “human” but plant-derived, bioengineered collagen.
(Although I’m willing to admit that this stuff may be perfectly, technically indistinguishable from “real, natural” human collagen.)
Perhaps I’m overly cautious. Perhaps I am too “skeptical” of modern medical “science” – but there seem to be plenty of good, logical reasons to be so.
It will be interesting to see where this goes.