Intellicell Biosciences Inc (fka SVFC)

[mave_rick]

SVFC


http://www.thelifesciencesreport.com/pub/na/the-stem-cell-revolution-can-jump-start-your-portfolio-jason-kolbert


Portion of the above mentioned article dated March 2013.


" Let me differentiate the indications. If you have an acute myocardial infarction—a heart attack—you don't want to have liposuction and wait an hour before your treatment can begin. In fact, you don't want to wait a minute. You want to be rushed into the cath lab, and as the interventional cardiologist is placing the stent to unblock the coronary occlusion, you'd like him or her to have the stem cells to inject. Though it seems unbelievable, many heart attack patients won't return to the hospital once released, so a cardiologist's best chance to treat the heart is right there, in the cath lab, during the crisis. I worry when companies claim it is best to wait until the heart becomes hypoxic, and then deliver cells. I believe, for acute injury, you want allogeneic models like those being developed by Mesoblast, Pluristem and Athersys.

"The good news is that cell therapy has virtually arrived. It's no longer a question of if, but when."

On the other hand, the autologous model, like Cytori's or IntelliCell BioSciences Inc.'s (SVFC:OTCPK) adipose sonifcation process (cells are separated using sonic energy), could be very attractive for cardiac patients with CMI. If we think of the lowest of the low-hanging fruit, we think of anybody undergoing a tummy tuck. What is happening to that fat now? It's being thrown away. Imagine if that was reintroduced into your body for rejuvenation. Now the person getting liposuction is a candidate for stem cell therapy. Many physicians are actually doing this today under minimally manipulated and homologous guidelines. The area is in dispute and represents a gray area in terms of FDA regulations.

I can see a day when stem cells from these procedures are cryopreserved. Down the road, should you break your arm or your ankle, those cells could be used to help you heal rapidly. I think Cytori's device has enormous potential. I respect the fact that it is targeting CMI with a peak oxygen consumption endpoint along a PMA (device) pathway.

Once the company completes the current phase 2 study successfully, all it will need to do is one modestly sized phase 3 trial. Proving safety is less of an issue with the device pathway, so the pivotal trial's focus is a p-value (statistically valid result) on a relevant endpoint.

TLSR: Do you have one or two ideas to close with?

JK: 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.

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.

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.

IntelliCell BioSciences has completed the preclinical protocols in anticipation of beginning a clinical trial for osteoarthritis of the knee under an FDA investigational new drug application in mid-2013. The company provides product today to ReGen Medical, and in doing so is building fantastic database of patient experience that will be used to focus on clinical applications."

IMO