Monthly Archives: July 2017

Liveyon LLC is the exclusive worldwide distributor of a regenerative medicine product that is derived from umbilical cord. This product contains cells, stem cells and growth factors which may serve as a therapy for various degenerative diseases/disorders.

Stem cells and cell based therapies have shown tremendous promise; yet controlled studies are still needed in order to confirm its efficacy. Professional judgment and expertise is needed in using these therapies for any therapeutic use, and we urge anyone embarking on the use of stem cell therapies or any regenerative medicine product to consult the national health data bases to evaluate current information from clinical trials. The FDA websites on human tissue should also be consulted to get its current evaluation of any regenerative therapy.

Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based or regenerative medicine products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.

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Research on Stem Cell Therapy | Liveyon Regenerative Medicine

By Reuters By Reuters July 8

Stem cell tourism in which patients travel to developing countries for unproven and potentially risky therapies should be more tightly regulated, according to a group of international health experts.

With hundreds of medical centers around the world claiming to be able to repair tissue damaged by conditions such as multiple sclerosis and Parkinsons disease, tackling unscrupulous advertising of such procedures is crucial.

These therapies are advertised directly to patients with the promise of a cure, but there is often little or no evidence to show they will help or that they will not cause harm, the 15 experts wrote in the journal Science Translational Medicine.

Some types of stem cell transplant mainly using blood and skin stem cells have been approved by regulators after full clinical trials found they could treat certain types of cancer and grow skin grafts for burn patients.

But many other potential therapies are only in the earliest stages of development and have not been approved by regulators.

Stem cell therapies hold a lot of promise, but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments, said one of the 15, Sarah Chan of Britains University of Edinburgh.

The experts called for global action, led by the World Health Organization, to introduce controls on advertising and to agree on international standards for the manufacture and testing of cell- and tissue-based therapies.

The globalization of health markets and the specific tensions surrounding stem cell research and its applications have made this a difficult challenge, they wrote. However, the stakes are too high not to take a united stance.

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'Stem-cell tourism' needs tighter controls, say medical experts - The ... - Washington Post

W

hen breast cancer patients get chemotherapy before surgery to remove their tumor, it can make remaining malignant cells spread to distant sites, resulting in incurable metastatic cancer, scientists reportedlast week.

The main goal of pre-operative (neoadjuvant) chemotherapy for breast cancer is to shrink tumors so women can have a lumpectomy rather than a more invasive mastectomy. It was therefore initially used only on large tumors after being introduced about 25 years ago. But as fewer and fewer women were diagnosed with large breast tumors, pre-op chemo began to be used in patients with smaller cancers, too, in the hope that it would extend survival.

But pre-op chemo can, instead, promote metastasis, scientists concluded from experiments in lab mice and human tissue, published in Science Translational Medicine.

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The reason is that standard pre-op chemotherapies for breast cancer paclitaxel, doxorubicin, and cyclophosphamide affect the bodys on-ramps to the highways of metastasis, said biologist John Condeelis of Albert Einstein College of Medicine, senior author of the new study.

Called tumor microenvironments of metastasis, these on-ramps are sites on blood vessels that special immune cells flock to. If the immune cells hook up with a tumor cell, they usher it into a blood vessel like a Lyft picking up a passenger. Since blood vessels are the highways to distant organs, the result is metastasis, or the spread of cancer to far-flung sites.

Depending on characteristics such as how many tumor cells, blood vessel cells, and immune cells are touching each other, the tumor microenvironment can nearly triple the chance that a common type of breast cancer (estrogen-receptor positive/HER2 negative) that has reached the lymph nodes will also metastasize, Condeelis and colleagues showed in a 2014 studyof 3,760 patients. The discovery of how the tumor microenvironment can fuel metastasis by whisking cancer cells into blood vessels so impressed Dr. Francis Collins, director of the National Institutes of Health, that he featured it in his blog.

The new study took the next logical step: can the tumor microenvironment be altered so that it promotes or thwarts metastasis?

To find out, Einsteins George Karagiannis spent nearly three years experimenting with lab mice whose genetic mutations make them spontaneously develop breast cancer, as well as mice given human breast tumors. In both cases, paclitaxel changed the tumor microenvironments in three ways, all more conducive to metastasis: the microenvironment had more of the immune cells that carry cancer cells into blood vessels, it developed blood vessels that were more permeable to cancer cells, and the tumor cells became more mobile, practically bounding into those molecular Lyfts.

As a result, the mice had twice as many cancer cells zipping through their bloodstream and in their lungs compared with mice not treated with paclitaxel. Two other neoadjuvants, doxorubicin and cyclophosphamide, also promoted metastasis by altering the tumor microenvironment. This showed that the tumor microenvironment is the doorway to metastasis, Condeelis said.

The scientists also analyzed tissue from 20 breast cancer patients who had undergone pre-op chemo (12 weeks of paclitaxel and four of doxorubicin and cyclophosphamide). Compared to before the chemo, the tumor microenvironment after treatment was more conducive to metastasis in most patients. In five, it got more than five times worse. No patients microenvironment got less friendly to metastasis.

Pre-op chemo may have unwanted long-term consequences in some breast cancer patients, the Einstein researchers wrote.

That finding is fascinating, powerful, and very important, said Julio Aguirre-Ghiso of Mount Sinai School of Medicine, an expert in metastasis who was not involved in the study. It raises awareness that we might have to be smarter about how we use chemotherapy.

Dr. Julie Gralow, a medical oncologist at the University of Washington, said that if pre-op chemo promoted metastasis, that should have shown up in studies that compared it to post-op chemo, but for the most part it hasnt. However, that could be because only tumor cells containing certain proteins that make them especially mobile are affected in this way. This is an interesting study, to say the least, Gralow said. I am willing to keep my mind open to the possibility that there are some breast cancer patients in whom things get worse with pre-op chemo.

One reason to question the findings, however, is that if pre-op chemo promotes metastasis in some patients, that might be expected to have shown up in studies of the therapy. Overall, in fact, those studies showthat neoadjuvant chemotherapy does not seem to improve overall survival, as the authors of an editorial in the Journal of Clinical Oncology wrote.

Thats not as bad as decreasing survival, of course. But Einsteins Dr. Maja Oktay, a co-author of the new research, cautioned that the typical length of the studies six or so years is too short to assess the risk of metastasis, which can take more than 20 years to appear, she said. Such patients might never be flagged as having metastatic cancer, let alone having it linked to pre-op chemo decades earlier, said Aguirre-Ghiso.

On a brighter note, not all breast cancer patients have the kind of tumor microenvironment in which pre-op chemo can promote metastasis. Whether they do or not can be determined by a simple lab test, but one that is not routinely done, Condeelis said.

Serendipitously, an experimental compound called rebastinib, being developed by Deciphera Pharmaceuticals, seems to be able to block the on-ramp to the metastasis highway. In a study currently recruiting patient volunteers, the Einstein scientists (who have no financial relationship with Deciphera) are studying whether rebastinib can improve outcomes in metastatic breast cancer.

Sharon Begley can be reached at sharon.begley@statnews.com Follow Sharon on Twitter @sxbegle

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Chemotherapy before breast cancer surgery might fuel metastasis - STAT