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Good article on Forbes 21 Feb 2013 13:38 #181

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Good article on Forbes 22 Feb 2013 01:03 #182

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This link keeps failing...can you post the text ?

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Good article on Forbes 22 Feb 2013 08:45 #184

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Michael Phelan is the CEO of SevOne. My Forbes colleague Tomio Geron recently wrote about his fast-growing IT company and Phelan contributed a guest post earlier this year at Eric Savitz’s CIO Network.

Phelan also has multiple sclerosis. Frustrated by the limited effectiveness of standard drugs for MS, he decided to try something more radical.



Harvard Stem Cell Researcher Targets ALS And 'The Watershed' Of Neurological Disease John FarrellContributor

He traveled to a clinic in Panama and had infusions of adult stem cells generated from his own body fat.

It worked so well, he’s going back for another treatment.

After my last post, highlighting some research on the potential adverse consequences of adult stem cell treatments, some readers, including Phelan, protested that such studies represented but a small fraction of the thousands of successful treatments people were getting offshore, and that I was overlooking the patient’s perspective.

I asked if he’d be interested in recounting his own story in more detail. Our Q&A was conducted by email.


Q: When did you first show symptoms of MS?

A: My symptoms started 7 years ago, in my late 40s. I’m 56 now.


Q: I’m assuming you began by seeking standard medical therapy. Can you tell me a bit about this, which drugs, and what led you gradually (or more speedily) to try a stem cell therapy?

A. I still use standard medical therapy. I have the best Neurologists in Philadelphia, at the University of Pennsylvania Hospital, and Jefferson. I was on Copaxone for 5 years. Last month I started on Gilenya. Unfortunately, the approved, standard drug therapy has not been effective for me. I considered the Tysabri® (natalizumab) risks too high.


Q. Before going abroad, you attempted to get into some clinical trials here in the U.S. Can you tell me about the clinical trials you registered for–and whether they explained why you did not qualify?

A. The first: Stem Cell Therapy for Patients With Multiple Sclerosis Failing Interferon A Randomized Study

The evaluation process is not funded; therefore I paid approximately $10,000 for travel to Chicago, for tests, MRI’s, etc. The opinion of the investigators was the risk related to aggressive chemotherapy was not worth the potential gain because I was 55 years old, and the MRI evidence did not confirm enough recent disease activity. The treatment is most effective in active, early stages. My stage was questionable.

A second clinical trial: Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS

The research team is headed up by Jeffrey Cohen, MD, of the Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research. I did not qualify because I would be over 55 at the end point. This study is very similar to the treatment that I received in Panama.


Q. How did you come to learn about the Stem Cell Institute in Panama?

A. I researched Pubmed, talked to physicians involved in U.S. studies and reviewed conference publications. I first learned about the Stem Cell Institute from Dr. Roger Nocera, author of Cells That Heal Us From Cradle To Grave.

I also noted that the Medical Director of the Stem Cell Institute was published: Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis.

Plus I read and viewed many personal testimonies of patients, such as famous Texas High School football coach, Sam Harrell.



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Q. You mentioned your first treatment at the Institute has helped restore functionality. Could you explain in detail?

A. I had visual problems for over a year before treatment, including double vision. After my first treatment in May of 2012, my vision problems resolved and I was able to continue driving. My mental and physical energy improved dramatically. I had urinary problems, including urgency and frequency, both resolved after treatment. Plus, I had reduced spasticity, less headaches and improved balance. I went from a 10-minute treadmill, 2mph limit to a 30 minute, 2.5 mph limit.


Q. What was your experience like at the Stem Cell Institute?



Harvard Stem Cell Researcher Targets ALS And 'The Watershed' Of Neurological Disease John FarrellContributor

A. The care I receive at the Stem Cell Institute and Hospital Punta Pacifica was excellent. They had a much more personal, detailed approach than I ever experienced in America. It really felt like “care”. The mini-liposuction was done at the Hospital Punta Pacifica in Panama, a Joint Commission International Accredited Johns Hopkins-Managed Hospital.


Q. Did you consider going to Celltex Therapeutics in Texas–which was discussed this week in Nature?

A. I certainly considered Celltex, but was concerned about FDA interference.

This is a big story. Perhaps, the biggest story in our lifetime. We are learning very quickly how the body heals. I’m grateful to have access to treatment. But, this should be available to everyone.

America is way behind. A recent study in Korea applied the same treatment: autologous, fat derived MSCs to Alzheimer’s with unprecedented results.

We got off track in America because adult stem cells are confused with embryonic stem cells. So, you have religious and financial interests halting progress in America. Adult stem cells can’t be patented, limiting the financial incentive. Plus, there are conflicted stem cell “experts”, whose research is in embryonic stem cells, spreading misinformation about adult stem cells.

As a result, the FDA created a new “minimally manipulated” threshold, which gives them authority over a medical procedure. This is a crime against ill people who can’t afford to travel overseas for treatment. America should be fast tracking this treatment, not slowing the adoption process to the crawl involved in drug approval.



Phelan’s case is a hopeful one. As this week’s issue of Nature points out:


Arnold Caplan from Case, did pioneering work on MSCs [mesenchymal stem cells] and refers to their action as “hit and run” healing. More than 250 MSC trials are ongoing or completed, he told the audience at an October 2012 summit. And even though most of these studies are small and none has led to regulatory approval for widespread use in the United States or Europe, Caplan says that he would use the cells. “If I had MS, I would be getting this therapy. I’d probably go offshore.”

This doesn’t change the fact that the business is chancy, however. As the Nature article also shows, after $32,000 spent, MS patient Ann McFarlane did not see improvement in her condition and was disillusioned by her interactions with Celltex.

Nature’s editorial in the same issue rightly urges the FDA to find alternative –and less expensive– ways for stem cell trials to be funded and carried out so that more patients like McFarlane and those with less financial resources than Phelan can benefit from the therapies in the near future.

But critics point out that the editorial presupposes that the FDA should be regulating stem cell treatments when it is by no means certain this is the case. “The FDA requirements, designed for products manufactured and sold on a mass scale, can’t be readily satisfied when it comes to treatments that are personalized to individual patients,” said Phelan.

“This is a medical procedure, not a drug.” He cited Former FDA Deputy Director, Scott Gottlieb’s opinion piece last fall in the Wall Street Journal urging the FDA to back off and let the adult stem cell treatment field grow in the U.S. without the heavy hand of federal regulation.

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Good article on Forbes 22 Feb 2013 08:50 #185

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The article has been taken down from Google news feed where I first saw it.Its a Forbes article out yesterday. There were 12 comments posted quickly all praising the article. All except on from Paul Knopler....

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Good article on Forbes 22 Feb 2013 08:51 #186

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Fas,The link from your site does work for me though....

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Good article on Forbes 22 Feb 2013 09:58 #187

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Yes- Joey, I had no problem following the link either. Hedge did.

It is an excellent article of which many has appeared over the years- but not so much in places like Forbes if you understand what I mean. There is still a gigantic bias in the media towards adult/ regenerative cell technology and the source FAT virtually unknown.
This is one of the reasons I am participating in spreading the gospel, but we are at an early stage STILL. and I need improvements in the accessibility of my site- for that I need sponsors though- that costs MONEY

Patience is all we can have despite Calhoun & Co -FAT WORKS :woohoo:

At the bottom of the article is a link to a WSJ article- which however is for subscribers only. Anybody can lay their hands on it and post it here???ß

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Good article on Forbes 22 Feb 2013 11:40 #188

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www.aei.org/article/health/the-fda-wants-to-regulate-your-cells/


The above link is from the AEI where Gottlieb is a regular contributor on Health issues. He has served in a variety of positions at the FDA. He has often been quite critical of the way the agency has been run, conflicts of interests, bureaucracy etc.
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