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Regulatory News Italy 22 May 2013 08:25 #484

  • d9dozrman
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A bit of positive news.

d9 :nice:

ROME
Law passed legalizing stem-cell research and treatment

22/05/2013

Italian Senate votes 259-8 in favor of law

Rome, May 22 - The Italian Senate overwhelmingly approved a law on Wednesday that legalizes stem-cell therapy and research. With 259 yes votes, two nays and six abstaining, the new law permits those who have begun stem-cell treatments to continue them. The law also budgets three million euros for an 18-month stem-cell therapy research programme sponsored by the health ministry, set to begin July 1. The Istituto Superiore di Sanita', a state health institution for research and education, will coordinate research, and work with the Italian pharmaceutical agency AIFA and the National Transplant Centre. The law also postpones closure of judiciary psychiatric hospitals until April 1, 2014. The stem-cell law officially approves what is already the practice in at least one Italian hospital, despite previous court rulings against stem-cell therapy. A toddler at the Brescia hospital in northern Italy has been undergoing stem-cell treatment which the government grudgingly approved of in March. At the time, the health minister said it would be risky to the child's health to stop treatments that were underway. Stem-cell treatment, which is legal in Italy in life-threatening instances, is contentious because it sometimes involves the destruction of a human embryo. Italy banned the use of embryos in stem-cell research in 2004, but in 2007 Italian researchers obtained adult stem-cells which they said were as effective as those obtained from embryos.

www.gazzettadelsud.it/news/english/47425/Law-passed-legalizing-stem-cell-research-and-treatment.html

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Regulatory News Italy 22 May 2013 09:22 #485

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Good news D9 thanks. So do you think this opens up therapy for many indications? MS Parkinsons, intercoronary injections and many others. I wonder if clinics will open and be able to charge customers from other European countries.

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Regulatory News Italy 22 May 2013 09:23 #486

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Hey this might be the push Japan needs to pass that stem cell law by June

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Regulatory News Italy 22 May 2013 09:50 #487

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joey, at this juncture it appears the use of cell therapy will be limited, primarily for the patients already undergoing therapy for their terminally ill conditions. Also, clinical trials will be conducted which were not allowed before. Nevertheless, a step in the right direction, that could open doors for other treatable conditions.

d9

ROME:
Italian lawmakers on Wednesday gave their final approval to a law that allows limited use of a controversial type of stem cell therapy which has been condemned by many scientists but has given hope to families of terminally-ill children.
The law gives the go-ahead for therapy being carried out by the Stamina Foundation on dozens of patients to continue, and allows for an 18-month period of clinical trials for the procedure, which had previously been blocked by Italian authorities.
The bill was amended from an earlier version and states the therapy must be carried out under regulatory oversight and using cells made according to the Good Manufacturing Practice (GMP) which the Stamina Foundation has not adhered to.
The Stamina Foundation says its treatment is based on mesenchymal stem cells and could treat diseases like spinal cord injury and motor neurone disease.
But leading scientists have warned that there is no evidence to suggest the treatment could work and no way to know that it will not cause harm.
Patients lobbied for the therapy to be given the go-ahead, receiving support from various celebrities including actress Gina Lollobrigida.
At one demonstration, protesters wore T-shirts with the slogan: "Yes to Stamina, Yes to Life".
The association Stem Cell Research Italy has branded the new law as "unacceptable" saying the therapy was not backed up by clinical data published in peer-reviewed academic journals.
US journal Nature said it was a "rogue" therapy.

www.channelnewsasia.com/news/world/italy-approves-law-on-controversial-stem/684222.html

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Regulatory News Italy 22 May 2013 10:56 #488

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Yes- I think this is a positive development in view of the fact that Italy already had a compassionate use of experimental drugs law and applies it here although possibly the therapy-say- is suspect.
At LinkedIn there was a big discussion on the paper written by ultra conservative ISSCR scientists- the ESC lobby so to speak- see attachment-





This is what I wrote there on the paper-
Thank you for your comments Thorsten- I do appreciate them, but they do not convince me. First- the story about the transplant patients was unknown to me although I have looked at the developments in regenerative medicine intensively for the past eight years, so I hardly think the general public would remember. Tells me mainly that these folks live in the past. The present is that thousands of patients have been treated with apparent success be it in clinical trials or in off-shore clinics, of course all placebo effect cases, but that is ok, as long as the patients get better. That awakens hope and expectations, not critism when a terminally ill patient dies after treatment. That happens daily on the surgery table with "scientific medicine" too.
To be honest- after reading your words- I decided to re-read the publication and this line, describing the risks and dangers of cell therapy, caught my eye-
"As inherently osteogenic and adipogenic cells, MSCs could generate bone or fat in the wrong organs if transplanted in sufficient numbers (Breitbach et al, 2007)". Actually I do remember "hearing and seeing" this statement in German television from the author in 2010, which was abused to knock down a non-vital organ application i.e. a regenerative soft tissue application, which even has regulatory clearance in Germany. So- yesterday I decided to see, what "the scientific community" had to say on the quoted paper and reviewed a large sample of the 50 citations the paper has at PubMed. Most papers, which generally related to mechanisms of therapeutic action in cardiac cell therapy, simply repeated the reported risk (which as we all know has not materialized in treatment of over 3000 human cardiac patients in Germany alone, where the Dimmeler/Zeiher procedure-to my knowledge- is even reimbursed by some private carriers). The authors of one paper on plasticity of transdifferentiation of BMSCs apparently read the paper more carefully and cited "Even if they are the stimuli of the microenvironment to direct transdifferentiation, it is also possible that the differentiation is directed towards unwanted tissues. Recently BMMSCs injected into rat hearts were shown to differentiate into bone tissue and to drive its calcification".
This is where the dogma and indoctrination comes in, which I referred to in my preceding post. If there is no trans-differentiation in the targeted tissue, there cannot be a therapeutic impact. This publication comes from the "scientific excellence organisation" which has been searching now for 40 years for that perfect cell that can differentiate in all known 213 tissue types of the body and prefers to continue wasting billions in continuing that quest for another 40 years, most likely without significant result. In the mean time anything that appears to work CANNOT work, since it cannot be "scientifically explained" and the hundreds of papers from prominent scientists, including Arnold Caplan, are frivalous un-scientific rubbish. The following quotation from the publication reveals their intentions:
Quote- Indeed, any putative paracrine factor involved should be identified and then developed into a drug, substituting for the infusion of cells that cannot stably engraft.End-quote. So there you go, for each anti-apoptotic, paracrine or other identified mechanism of therapeutic action, a chemical induction compound should be developed. Biologics not allowed.
This publication is worthy of my virtual waste-bucket. Surely all members of this group are beneficiaries of some CIRM funds or alike and nobody works in the cell therapy industry as I know it. If you do- read the chapter- MSC´s- "Most Suspicious Cells?" again and be honored with your endeavors.
Fortunately there IS some change- the democratic "trias politica" nations are slowly waking up (see my post on Japanese legislation) and seeing that the populations they serve and govern are deserving the benefit of the applied scientific evolution, which "Ewig-gestrigen" as they call scientists who live in the past in my host country Germany, are trying to hold up, in concert with large pharmaceutical interests.
I see the Italian case with different eyes now- even if its "some stumbling"- the flaws certainly can be straightened out. And I also believe it is good when some terminally ill children survive due to placebo effect and non-scientific means, relative to the inevitable.
Attachments:

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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:

Regulatory News Italy 22 May 2013 15:45 #489

  • myownhedgefund
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joey

remember...we are still talking a self pay world in Italy.

I view the news more as cover for those who have been doing cell therapy treatments.

Still a step in the right direction.

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