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Sunday, 10/26/2014 8:03:22 PM

Sunday, October 26, 2014 8:03:22 PM

Post# of 91007
We're not going to get real institutional ownership in cell therapy stocks until they have data and proof of concept. If you're a fund manager with $10 billion ($10B) under management, you can't afford to buy a micro-cap company or even a big-cap company that is thinly traded in the U.S. Companies like edit need to establish a more significant U.S presence that will lead to better share liquidity, which will then allow institutional ownership. Then I believe institutions will say, "OK, if I own edit, what else might work?" They will start scouring the landscape to find companies like edit. Athersys or Pluristem, which are allogeneic counterparts to edit. The fund managers can then ask, "Are these stocks cheaper alternatives?"

TLSR: By the way, how is your ankle?

JK: Thank you for asking. I'm not just an analyst; I'm also a patient of Dr. Steven Victor, founder and CEO of IntelliCell BioSciences Inc. (SVFC:OTCPK). As you remember, I rotated my ankle this past winter with extensive damage to the ligaments. I was evaluated at the emergency room and had an orthopedic specialist follow up. The original prognosis was 3–6 months of recovery with minimal physical stress, such as running. Dr. Victor treated my ankle and for me, an n=1, the results were amazing.

Truly, the treatment was as close to minimally manipulated cell therapy as one can get. A stromal vascular fraction was extracted from my belly fat. The harvest was 750M cells; 50M were injected locally into my ankle, with 700M administered systemically. Dr. Victor believes that the systemic administration of cells in conjunction with the local administration creates two modalities of repair. The local repair process accelerates and is supported by the systemic impact, which address generalized inflammation.

I will tell you, my ankle was close to 100% within 10 days of treatment. I had a fantastic season of skiing this past winter, and have been water skiing all summer long. Ankle strength is critical in water skiing.

Clearly, I personally believe cell therapy works. I believe it's viable. I know that from my personal experience, and while I'm only one patient, the results were dramatic. I think cell therapy represents the future of medicine.

TLSR: The therapy that you had administered did not have to be approved by the FDA. There is an exemption for minimally manipulated biological tissues. No premarket approval (PMA) or even 510(k) clearance is necessary. Correct?

JK: That is exactly correct. In the case of IntelliCell BioSciences, cells are extracted from adipose tissue, but there is no collagenase (collagen enzyme) added to digest it. The company essentially applies sonification (ultrasound) and separates out the stem cells. Within an hour it reintroduces the cells to the patient. Because cells are so minimally manipulated and because the entire process is done onsite, in the room adjacent to the patient, it likely qualifies under the FDA exemption that allows physicians to treat patients at their discretion as a "practice of medicine" issue.

Plastic surgery centers around the world are discarding patients' fat. But we would say that there is gold—your stem cells—in that fat. I know that Dr. Victor has treated more than 300 patients, and he's had some amazing successes. These are not FDA-controlled trials. They're not blinded. They're not randomized. He is one of many clinicians finding ways to harvest stem cells and treat patients with them, with amazing results. But I want to be very clear: I'm not promoting the use of stem cells without clinical trials. Clinical trials are the only pathway for the industry to commercialize the value of this technology. That said, the evidence is building that our bodies possess the ability to heal with a little bit of coaxing from good science.

http://www.thelifesciencesreport.com/pub/na/is-cell-therapy-the-future-of-medicine-jason-kolbert

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