Dear Colleagues!  Today is Pharma Veterans Blog Post #171. Pharma Veterans shares the wealth of knowledge and wisdom of Veterans for the benefit of entire Pharma Community. It aims to recognize and celebrate the Pharma Industry Professionals. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. If you wish to share your stories, ideas and thoughts, please email to asrar@asrarqureshi.com for publishing your contributions here. 

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  • Why is stem cell research gaining buzz?

Stem cells generate so much buzz because they have the unique ability to turn into different types of cells. This means they have the potential to rebuild organs that are diseased, which in the medical field is known as regenerative medicine. Early on, scientists focused on stem cells taken from embryos because those cells naturally transform into the myriad ones that develop into the baby tissues and organs.

But ethical issues and federal regulations related to these cells sent researchers scrambling to find alternatives.

Today, cutting-edge scientists are working to coax adult blood cells to become nascent cells akin to the embryonic kind by adding certain DNA molecules. These “induced pluripotent stem cells,” which have shown early promise, generally require months of careful manipulation in a lab and thus are mainly limited to top medical centers.

Most of the for-profit clinics have settled on using cells taken from fully developed tissue, known as “adult stem cells.” By using cells from a person’s own body, these clinics can complete a treatment in a day or a few weeks.

Doctors, typically in liposuction, get a little fat or remove some bone marrow (which is a rich source of stem cells), put it through a few steps to remove other tissue, then inject the stem cells where they want them to proliferate. Someone who is coming in with arthritic hip pain, for example, might have cells removed from his/her belly and inserted into hip.

Critics say, the for-profit clinics, currently claim that they can treat all forms of disease with adult stem cells are not being honest. Much more study is needed before any of these claims can be substantiated, says Kapil Bharti, Ph.D., a research scientist at the National Eye Institute of the National Institutes of Health who is at the leading edge of research on using pluripotent cells to treat macular degeneration. “The problem with the cells is what we don’t know. Those clinics inject the cells and hope they will secrete something beneficial, but every time they do the injections, they are rolling the dice,” he says.

The scientific consensus is that stem cells taken from fat or bone marrow are not as malleable as embryonic cells, meaning that rather than turn into completely different cells, they mostly create more of the same tissue. “There is zero evidence, for example, that bone marrow tissue can make eye tissue, even though many of these clinics say it can. The cells don’t integrate, so they die off,” Bharti says-and the injections may cause significant damage in the process.

  • What are stem cells used for?

At the moment, stem cell treatments are medically recommended only for a small number of blood disorders. To treat leukemia, for example, patients typically have their bone marrow harvested before their bodies are blasted with high-dose chemotherapy. The stem cells from the marrow are then reinserted into the bloodstream to restore damaged cells there.

Early-stage research involving other conditions reveals why physicians are so excited about the method’s future prospects. A very small industry-funded clinical trial in Australia found that in people who had the Anterior Cruciate Ligament (ACL) in the knee, reconstructed those who subsequently had stem cells injected into their knees had less pain and better physical results on their MRIs than did a control group. An ongoing multiyear study of 110 patients with relapsing-remitting MS is finding that those treated with stem cells from their own bone marrow (along with some chemotherapy and/or radiation) are much less likely to have their disability worsen than those on standard disease-modifying drugs-an incredible 6% versus 60%.

  • The problems with stem cell injections

While some patients were lucky to have had positive results, this is not true for many others. That is one reason stem cell scientists are angry that the Food and Drug Administration (FDA) hasn’t come down harder on for-profit clinics. Between 2011 and 2017, the FDA issued some warning letters, and the Department of Justice filed for injunctions against only two clinics (one with multiple locations) this past May. In December 2018, the FDA issued yet another warning after 12 patients fell seriously ill having received stem cell injections. Litigation is ongoing, although the clinics can still see patients.

It might seem that there is no danger in receiving a treatment using your own cells, but that is not the case. “People have suffered very serious complications,” says Leigh Turner, Ph.D., an associate professor in bioethics at the University of Minnesota.

An article in Nature counts nine lawsuits in which people alleged that their treatments for diabetes, lupus, lung disease, cosmetic surgery, and more, caused them harm. A report in the New England Journal of Medicine described three women with macular degeneration whose vision significantly worsened (two are now legally blind) when stem cells harvested from belly fat were injected into their eyes. Several stem cell clinic patients have died.

Doctors were initially excited to think stem cells might repair diseased hearts, but a 2017 study on mice found that when the cells were injected, they turned inflammatory and worsened heart disease. (More research is being done.)

Another big issue is money. Although one injection of stem cells several years ago helped Olympic track and field hurdler LaVonne Idlette heal tendinitis in her knee, when she went back to treat a pulled hamstring muscle, another injection did nothing. “At $1,200 a shot, it was ridiculously expensive,” says the 32-year-old Miami resident, now an attorney.

To be continued……

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