360 Stem Cell & Regenerative Medicine Newsletter - July 11, 2016

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360 Stem Cell & Regenerative Medicine Newsletter - July 11, 2016

Featured video- World Stem Cell Summit overview:
360 Editor’s comment: In defense of Dr. Paul Knoepfler
I have heard lots of criticism about our friend Dr. Paul Knoepfler and his influential blog. Paul is stretching his attacks on unscrupulous, deceptive stem cell clinics so far as to impugn the integrity and motives of many notable stem cell scientists, advocates and reputable organizations that are pushing for an accelerated pathway for regenerative cellular therapy.

So, is Paul merely some sort of “moral narcissist” ignoring the plight of patients in favor of well-funded and vested corporate interests wedded to overly stringent regulation, no matter the consideration of low risk to patients? Probably not.

Even though Paul seemingly refuses to recognize that the policy debate has shifted to a discussion in favor of an “accelerated” pathway rather than “conditional” pathway, the record reflects that he recognizes the current regulatory scheme needs an overhaul. He wrote in his recent op-ed in the San Francisco Chronicle: “The stem-cell status quo won’t do, but there are more prudent ways to move forward. FDA programs already exist for accelerating new therapy development. For instance, one called Breakthrough could quickly but more safely get innovative stem-cell therapies to patients. The FDA has not utilized these programs for stem cells, but it should.”

So Paul and I agree on some things. “The stem cell status quo won’t do.” Here’s a suggestion. Let’s support lawmakers to work on the details to get our field moving to the benefit of patients.

And let’s agree that a blog constantly attacking the motives of all those trying to bring safe and effective treatments quicker to patients is not engaging in a helpful manner to change the status quo. An advocate supporting change does not equate to being in favor of lax FDA regulation or being supportive of bad or deceptive clinical practice. Suggesting otherwise is divisive to the field.
World Stem Cell Summit
Pre early bird registration discount expires in July! – World Stem Cell Summit & RegMed Capital Conference
Pre-early-bird registration is available for a limited time for the 12th annual World Stem Cell Summit, the original, translation-focused, interdisciplinary, networking, and partnering conference serving the stem cell science and regenerative medicine communities.
  • Give high-touch visibility to your work, product or service
  • Connect with thought leaders, decision makers, -and influencers from the top organizations in the field
  • Associate your brand with a world-class event
  • Break the silos: forge collaborations and build relationships across disciplines
  • Expand your knowledge about hot topics and future trends
Learn more.
CNN: Gene-Editing Shows Promise Against Herpes
Research at the University Medical Center in Utrecht, Netherlands revealed that CRISPR-Cas9 gene editing technology can be utilized to target the herpes virus. Experiments on monkey and human cells in the petri dish appear effective. More basic research is required before animal and human trials, but what scientists have shown so far holds promise. Read article.
World Stem Cell Summit
Twin City Business: Signature Mayo Heart Cell Regeneration Technique Passes Key European Trial
“A signature research project of the Mayo Clinic’s Center for Regenerative Medicine – using stem cells to treat ischemic heart failure – has proven effective on enough patients in a European clinical trial to prompt its corporate backer to accelerate commercialization efforts. The results heralded the first time heart cell regeneration has been shown effective in a large-scale trial and could represent a major win for the Mayo center, which began work on the concept a decade ago. The product, C-Cure, is being developed by the Belgian company Celyad, under an exclusive license from Mayo. Touted as a potential paradigm-shifter in treating the dire condition, the technique was co-developed by Dr. Andre Terzic, director of the Rochester clinic’s regenerative medicine center, as one of its first big projects.” Read article.
UPI: Stem Cell Reprogramming Allows Scientists to Model Autism Development
Creating induced pluripotent stem cells based on skin samples from patients with autism, Salk Institute researchers have modeled the development of neurons providing new understanding of the condition. Read article.
San Diego Union-Tribune: Young Stem Cell Scientists Struggle for Funding
Biotech journalist, Bradley Fikes, has written an insightful article about the challenge of young scientists to secure adequate funding for their research. “The result is a workforce dominated by experienced, older stem cell scientists, presenting a discouraging prospect for newly minted researchers trying to break into the field. And that poses a long-term challenge because those older researchers will sooner or later have to be replaced. It's not just stem cells: the entire workforce of NIH-funded researchers is aging. In 1980, less than 1 percent of those researchers were age 65 and over. By 2010, those 65 and over exceeded 10 percent, according to the study, published in the journal Cell Stem Cell.” Read article.
PBS- NovaNext: Replicating Life in Code
Journalist Cynthia Graber presents the amazing work of Dr. Michael Levin of Tufts Center for Regenerative and Developmental Biology and his team, who “reverse engineered” the flatworm to create a simulated computer model. The model can help anticipate the results of experiments before they happen. “It took 6 billion simulated experiments, 26,727 generations of models.” To learn more read article.
CNN: Stem Cell Study for ALS patients Shows Promise, Yet Causes Pain
“Stem cell research can run the gamut from Nobel Prize-winning scientists to hucksters in lab coats making a buck off desperate, seriously ill people. The results of one new study may be less than hoped for, but the science is sound: The study concluded that injecting stem cells into the spinal cords of patients with amyotrophic lateral sclerosis (ALS) is safe in most, though not all, cases. Unfortunately, the procedure provided no benefit to patients, though it caused substantial pain to two of the study participants.” Read article.
Huffington Post: Scientists Are Homing In On The Secrets Of Limb Regeneration
For the study, researchers compared the genetic makeup of three species with known regenerative capabilities: two fish — zebrafish and bichir — and axolotl salamanders. This research identified “previously unassociated blastema genes and the extensive regulation” by microRNAs, the study says, “which could serve as a foundation for future functional studies to examine the process of natural cellular reprogramming in an injury context.” Read article.
The Comfort Sound
Knoxville News Sentinel: Tennessee Man Continues Crusade for Stem Cell Research Legislation
Here is the inspiring story about patient advocate Doug Oliver who is taking his passion for regenerative medicine to Washington in support of an accelerated regulatory pathway for regenerative cell therapy. Read article.
360 editor’s note: DON’T MISS A THING! KEEP INFORMED on the latest developments relating to stem cells and translational medicine at the online Stem Cells Portal. The Portal is affiliated with the official journal of the Regenerative Medicine Foundation, Stem Cells Translational Medicine, published by AlphaMed Press.
Korea Joongang Daily:Korean Government Cautiously Approves Embryonic Stem Cell Research
“The Korean health authority gave approval to a private university to carry out a project in embryonic stem cells, resuming controversial research that has been shut down for seven years. Professor Lee Dong-ryul of CHA University in Pocheon will lead a team of researchers in a four-year human embryonic stem cell research aimed at treating incurable diseases through the replacement of damaged cells and tissue, the Ministry of Health and Welfare announced. Nearly 600 human eggs will be used for the experiment, 100 of which will be non-frozen. Until the study wraps up on Dec. 31, 2020, a so-called management committee formed by the ministry will visit the research lab every year to check whether the team abides strict ethical orders from the government, a key condition imposed for the approval.” Read article.
Phys.Org: Fido Forever? South Korea's Dog Cloning Clinic

With apologies to Patti Page:
How much is that cloned doggie in the window?
The one with the waggly tail
How much is that doggie in the window?
I do hope that cloned doggie's for sale

Answer: $100,000. Read article.
CNN: FDA Halts Cancer Immunotherapy Trial After 3 Patient Deaths
Following two patient deaths last week and another earlier this year, Juno Therapeutics announced Thursday that it is putting its "ROCKET" trial on clinical hold, at the direction of the U.S. Food and Drug Administration. The patients enrolled in this Phase II trial are adults with relapsed or refractory B cell acute lymphoblastic leukemia. Read article.

360 Newsletter Editor

Bernard Siegel
Executive Director
Regenerative Medicine Foundation

Bernard Siegel's TedX talk "Stem Cells and the Transformative Power of Hope"

About RMF

The nonprofit Regenerative Medicine Foundation is an influential global network of stakeholders from patient-advocacy, science, and industry that serves as the principal coalition- builder across all disciplines and segments of society. Through RMF’s RegMed Action Coalition, reports, newsletters, the flagship World Stem Cell Summit and RegMed Capital Conference, special projects, speaking engagements, world-renowned advisory boards in science, law and policy, educational resources, teaching initiatives, and strategic relationships, RMF serves as the foremost channel of knowledge between leading regenerative medicine experts, patient advocates, and those who make policy for the general public.

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Category: Biology
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