Sometimes 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 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.