Intellicell Biosciences Inc (fka SVFC)

[Shatner2]

Here is an article that should be of interest. Its from the February 2014 edition of Journal of the American Academy of Orthopaedic Surgeons. It's titled, Application of biologics in the treatment of the rotator cuff, meniscus, cartilage, and osteoarthritis. It also happens to be the only publication co-authored by our favorite doctors, drs. James Andrews, Adam Anz, and Joshua Hackel from the Pensacola Center of the Andrews' Research and educational institute. The location where they will be conducting our IND clinical trials for osteoarthritis of the knee. Here's a link along with the abstract.

http://www.ncbi.nlm.nih.gov/pubmed/24486753


J Am Acad Orthop Surg. 2014 Feb;22(2):68-79. doi: 10.5435/JAAOS-22-02-68.
Application of biologics in the treatment of the rotator cuff, meniscus, cartilage, and osteoarthritis.
Anz AW, Hackel JG, Nilssen EC, Andrews JR.

Abstract:
Advances in our knowledge of cell signaling and biology have led to the development of products that may guide the healing/regenerative process. Therapies are emerging that involve growth factors, blood-derived products, marrow-derived products, and stem cells. Animal studies suggest that genetic modification of stem cells will be necessary; studies of cartilage and meniscus regeneration indicate that immature cells are effective and that scaffolds are not always necessary. Current preclinical animal and clinical human data and regulatory requirements are important to understand in light of public interest in these products.

This article is simply a review of the compilation of current literature at the time of publication in regards to the application of biologics in the treatment of the rotator cuff, meniscus, cartilage, and osteoarthritis. Considering we announced our engaging inVentiv Clinical as CRO for osteoarthritis IND a month and a half later (4/14/14), I would consider this review done by the drs. as a means to become totally up to date with current literature as well as current regulatory requirements. All important things when you're about to embark on an IND and begin treating patients.

I'll be interested to see what the clinical trial design will look like but from what I can gather on reviewing other research articles it seems that 3 to 6 months post treatment with adipose derived stem cells is usually the measured primary/secondary endpoint. So depending on how many individuals are enrolled in this trial we could see results pretty quickly after initiation. Once they have gotten the results from a large enough sample size they would want to show that they are statistically significant results seen in terms of growth of cartilage visualized with an MRI and improvements seen using various pain/disability scales. It seems they may have the intention that once they get phase I/II data they will want to publish this data in a research journal.

From the same press release regarding engaging inVentiv as our CRO, Dr. Victor says, "This IND study is important for proving the company's patented technology of Ultrasonic Cavitation as a method of separating stromal vascular fraction cells from lipoaspirate." Think about this for a second. We're not just only conducting an IND for osteoarthritis of the knee. We're looking to prove with statistical significance that our technology not only works but works better. Once they show that cartilage is grown and pain/disability is improved with statistical significance and they have that published in a peer reviewed journal we will be golden. After all, a joint is a joint. Drs. could use this "off-label". Using the reasoning that if it grew cartilage and improved pain/disability scores in the knee osteoarthritis, then why wouldn't it work in cases involving the elbow, ankle, rotator cuff, meniscus, cartilage deficiencies, etc?

Not only will our new national sales director be able to point at some hard peer reviewed evidence when selling drs. on the idea of adding an intellicell lab in their facitlity but the doctors will also be able to show this evidence to their patients. Remember, because our process doesn't use exogenous enzymes such as collagenase to separate the SVF and we don't culture our cells (competitors culture cells using Bovine serum) we aren't obligated by the FDA to perform an IND in order to treat patients using our technology. All we need is the initial proof and we'll have that added to our arsenal to help ramp up revenues at our current and future lab locations. Anywho, those are my thoughts.

Shatner2