Interview with Dr. Steven Victor of IntelliCell Biosciences (SVFC)

Steven VictorSometimes science can move at warp speed and that is even more true of the stem cell field.

One stem cell establishment that seems to be in a particularly intense period of activity and that has drawn a great deal of attention lately is IntelliCell Biosciences, headed up by Dr. Steven Victor.

The company’s financial state and its interactions with the FDA have drawn particularly intense attention and scrutiny of late. Below is my interview with Victor conducted this weekend where I asked him tough questions about recent events. I want to thank Dr. Victor for taking the time to answer the questions for the blog.

1. There is a lot of buzz about IntelliCell right now related to money issues. For example, the apparent Foreclosure Sale/Auction (perhaps now canceled?)  and various lawsuits related to funds allegedly owed by IntelliCell have some investors worried.  Does IntelliCell have a cash flow problem? What is the company’s financial state? Stable?

Victor: As you can see in our 8-k (Monday Aug 12) that the auction has a TRO and you can see what TCA and Ironridge did.  We are in the process of working out a payment of this loan originally from TCA and you can read the 8k from the week before for more info.

2. Is IntelliCell still treating patients at this time? Does it plan to do so for the foreseeable future? New patients?

Victor: Intellicell only makes (manufactures as per FDA) a quality cellular product in a cGTP lab under strict SOPs (took us over 1 year to write and still writing) that we test for cell count, viability, endotoxin, gram stain and do sterility plates that we send out so the product is sterile. We do not make any claim (i.e. Clinical) and then after QA release give the cells to the treating physician who treats his patient under the practice of medicine at the same facility during the same procedure.  It takes one hour to do the protocol with all the FDA paperwork so it is important to understand that Intellicell does NOT treat patients nor make any clinical claims.

3. I noticed that in the most recent 483, the FDA seemed to me to unambiguously refer to the IntelliCell stem cell product as a “drug” multiple times and it did so in the 2012 483 and in the 2012 Warning Letter. Do you believe that your company’s product is a biological drug? Why or why not? Will you need to file an IND?

Victor: This has been a long dialogue with the FDA and yes the inspector used GMPs instead of GTPs and as you know the manufacturing of a cellular product is not GMP.  GMP is used for making a drug that is millions of pills or cream from a single batch while GTP are when each patient is a batch so we believe in that respect she was wrong.  However under GTP the FDA can still call a cellular product a drug if it does not meet 1271.10 (a) or 1271.15 (b) but we strong believe we meet these rules and are a cellular product and not a drug.

4. Several parties seem to be alleging that IntelliCell’s sonication protocol kills all the cells in the prep. Do you have a response?

Victor: We have done over 300 patients with positive clinical results from growing new cartilage on MRI, mucous membrane, bone, heart muscle, etc etc and our flow cytometry on over 800 specimens (some for research) have shown cell counts and viability over 85% and we have shown CD antibody markers and photographed our cells using Amin and we have grown on cells in culture. If you do not follow our protocol exactly you will kill the cells.

5. In your response to the most recent FDA visit you mentioned a spirit of transparency at IntelliCell. What does that mean? For example, are you willing to release to me your patient consent form template? Do you have concrete examples of openness or transparency?

Victor: We are considering making public our response to the FDA 483….stay tuned

6. Where do you see IntelliCell in 12 months? How about in 3 years?

Victor: Our business plan is to open our cellular lab in ambulatory surgery centers and hospitals and sell our cellular product to physician Also in the near future we will engage in FDA IND clinical studies for osteoarthritis, rectal anal fistula, and probably cardiac and exploring others

7. What excites you most about the stem cell field? What concerns you the most?

Victor: The most exciting part of the stem cell field is seeing the patients get better especially the ones with unmet clinical needs.  My major concern is the cowboys out there who just make cells in their kitchen and do not follow the cGTP and SOP and a patient will get hurt.  The big mistake is that companies and doctors think that manufacturing cells is part of the practice of medicine and I disagree.  The use of the cells in the practice of medicine but the manufacturing process is governed by the FDA guidance for cGTP cellular products.  And as you know to follow cGTP/SOP is for patient safety and is a lot of work but I believe it is essential.  Sorry I can not give you more information……come visit and you will learn more when you see what and how we do it.

IntelliCell Foreclosure Sale

IntelliCell Foreclosure SaleIntelliCell BioSciences has had a terrible year.

Well, there’s terrible and then there’s terrible!

Things seem to be getting worse.

For background, I detailed its troubles, ups, and downs here in a previous post.

I was just working on a new draft post on the most recent, concerning FDA 483 report on the company, which I will release soon (it was released to me by the FDA last week) in a new post coming up, when I heard the news that reportedly the company is in foreclosure or at least is having some kind of foreclosure sale.

The Foreclosure Sale Announcement, posted in the NYT online classified ads, is shown above in a screenshot (note that after clicking that link that you need to chose “business opportunities” and then pick the location as NY Metro Area. The IntelliCell auction announcement should then pop up.

Is this the end of the line more broadly for the company?

If so, keep in mind this is still, in theory at least, a publicly traded company. What happens to stock holders?

If this is not the end of the road, and the company continues to survive, what does this sobering event mean for its future?

Wall Street Weirdness Over Stem Cell Biotech Intellicell (SVFC)

Intellicell SVFC volume 2013

What the heck is going on with Intellicell Biosystems, Inc. (SVFC, also SVFCE), a stem cell corporation run by Dr. Steven Victor?

Why are some on Wall Street seeming so bullish on the company lately?

What’s the real story and the facts?

What is the key background on this company?

Wall Street has been buying and selling this stock in a frenzy of activity pushing volume up dramatically (see bottom chart above from wallstreetnewscast.com) in the last month even as the company has faced mostly bad news from my view and a collapsing stock price (upper chart).

An example of the bad news is that Intellicell has had to deal with some litigation (more here) and has in addition been facing FDA scrutiny including a serious action called an “FDA warning letter”.

More recently, Intellicell was reportedly again inspected by the FDA in May-June of this year.  About a month ago, I contacted Victor to ask for the release of a recent FDA inspection report of Intellicell or to see if he’d answer some questions, but he did not reply.

While the price per share (PPS) has fluctuated day-to-day a great deal, overall it has not substantially recovered from a broad perspective. For the past 12 months, the stock PPS has tanked, down more than 6-fold. Investors in the company in some cases have lost a lot of money.

However, over the last month the stock has bounced up somewhat, up 2-3 fold (although down a great deal the last two days).

What the heck is up with that?

There has been some very up-beat talk on Wall Street including an interview piece featuring Jason Kolbert of the Maxim Group, who seems bullish on the company:

“I’d like to talk about IntelliCell BioSciences—and I know this will be controversial, only because its CEO, Dr. Steven Victor, is also the founder of ReGen Medical. ReGen Medical is a state-of-the-art hospital in midtown Manhattan that provides stromal vascular fraction cellular therapy, which contains stem cells, to patients today. The hospital is a beautiful, brand-new facility that treats high-end patients.”

This seems like very enthusiastic talk considering the overall picture for Intellicell is quite complicated.

Kolbert goes on to make very definitive statements regarding regulatory compliance matters for the company that to me seem overly simplistic and surprisingly upbeat:

“The therapy is provided to patients through physicians (orthopedists, urologists, plastic surgeons, etc.) that have practicing rights at ReGen Medical. The clinicians are allowed to put a patient’s own cells back into his or her own body, provided the cells are not manipulated, processed or expanded. This is in accordance with the FDA’s “minimal manipulation and homologous use” rule.”

That sounds like company boiler plate verbiage to me.

In fact, the question of whether Intellicell’s product is compliant with the FDA’s minimal manipulation definition seems, at least based on publicly available information, to be far from resolved. It is quite possible the FDA will determine the product is more than minimally manipulated. Update: I would also note in regards to the issue over whether Intellicell’s product is a drug/more than minimally manipulated that in the FDA warning letter last year to the company, the FDA stated that Intellicell’s product was a 351 drug and was more than minimally manipulated.

It is also not at all clear that the FDA will view the use of the Intellicell stem cell product as homologous use. Thus, in my opinion, Kolbert’s statements about Intellicell seem too cheery and could end up being flat out wrong. We just don’t know.

Interestingly, Kolbert also says the company uses stromal vascular fraction (SVF; emphasis mine):

“The IntelliCell process, branded IntelliSonics, is similar to the Cytori process in that they both use lipoaspirate. But the IntelliCell process produces a different cellular population because, with its sonification (ultrasound) process, the blood components are not washed out. The stromal vascular fraction of IntelliCell contains the hematopoietic cells. The final product is quality-controlled, checked for any contamination and cell viability is measured.”

That is a big can of worms.

You see, the FDA has defined SVF as more than minimally manipulated (aka a drug; see actual FDA letter to address this question at the bottom of the page at this link)) and that would suggest that Intellicell’s stem cell product is a drug, which could be very problematic for the company, which argues its product is not a biological drug.

It seems that the eventual release (hopefully sooner rather than later) of the most recent 2013 FDA inspection report will tell us a great deal about where this company really stands and the prospects for the future.

Disclosure: I have no financial interest in Intellicell.