Fat-derived stem cells hold potential for regenerative medicine


As researchers work on reconfiguring cells to take on new regenerative properties, a new review from Penn Medicine plastic surgeons sheds additional light on the potential power of adipose-derived stem cells – or adult stem cells harvested from fatty tissue – in reconstructive and regenerative medicine.

Reconstructive  have clinically integrated “fat grafting” into different  for years, for breast, facial, and other reconstructive and restorative surgeries, with good success. Now, researchers are beginning to understand the power that  holds. This new paper, published in the Aesthetic Surgery Journal, enforces that adipose-derived stem cells can be routinely isolated from patients and, once molecular methods are worked out, may be useful for a multitude of regenerative medicine applications.

“The opportunities for regenerative medicine interventions based on  are tremendous. It is critically important for us to better understand the biology of these cells so that we can develop novel, safe and effective treatments for our patients using their own cells.” said the paper’s senior author, Ivona Percec, MD, PhD, assistant professor in the division of  in the Perelman School of Medicine at the University of Pennsylvania.

Many groups are looking into different modes of isolating and modifying these cells for their regenerative properties, including experts at Penn’s Institute for Regenerative Medicine and around Penn Medicine. For example, Dr. Percec’s team is conducting translational research into the mechanisms controlling adipose-derived stem cells, and how they contribute to the normal human aging process.

Stem cells can undergo multiple divisions without differentiation, making them useful tools for cell-replacement therapy.  can convert to any cell type, whereas adult stem cells, like the stem cells derived from fat, can differentiate into many, but not all, cell types. A person’s own fat tissue could then potentially be converted into cells specially designed to repair damage to the heart, cartilage, blood vessels, brain, muscle, or bone.

As regenerative medicine techniques are refined, experts will continue to explore the utility and benefits of stem cells derived from adipose tissue.

Building Better Blood Vessels


Regenerative medicine continues to flourish. Yet it is still a major breakthrough when new techniques are demonstrated to be both safe and effective in humans. One area with great promise is in the successful grafting of blood vessels in patients with renal disease.

Medscape spoke with Laura Niklason, MD, who, along with colleagues, recently published a paper[1] in the Lancet reporting results from two clinical trials investigating the application of a new vessel grafting technique.

Medscape: Let’s begin by having you explain a bit about the issues facing patients with end-stage renal disease who must undergo dialysis. What are the particular challenges for this group of people?

Dr Niklason: Patients who are on dialysis for kidney failure have a really challenging existence. They have to go to dialysis centers three times a week, for 3-5 hours each session, so that they can have their blood cleansed in the dialysis machine. It’s a big burden for them and also very expensive for the healthcare system. It probably costs $80,000-90,000 a year for Medicare to care for each dialysis patient. It’s burdensome for the patients, and it’s also expensive for the system.

One of the key drivers of patient discomfort and difficulty is failure of what we call “dialysis access.” In order to do dialysis, we have to be able to withdraw blood from the patient at a high rate, around 1 L/min, to run it through a dialysis machine and clean the blood. In order to do that, we need a conduit, a connection between the patient’s artery and the vein that is sitting underneath the skin. That conduit gets punctured with large-bore needles three times a week in order to draw blood out of a patient, clean it, and then return it to the patient.

One of the things that really contributes to the difficulties of the dialysis patients is when this dialysis conduit fails. When they become clotted, otherwise obstructed, or infected, then this conduit has to be removed, replaced, or intervened upon. And that contributes to morbidity and overall patient misery.

What we’re hoping to achieve with this new product, the human acellular vessel, is to hopefully have a graft that will suffer fewer of these complications and/or last longer, so that patients can go substantially longer before they have to get a new conduit placed.

Medscape: Given the difficulties with viable biological alternatives, tell us about how you and your co-investigators settled on culturing acellular vessels.
Dr Niklason: I think, as a comparison to other biological materials, there are two real distinctions of our vessel vs other products or other things that have been tested in man.

Many other biological conduits are derived from animal sources—typically, pig sources or bovine sources, although there are some conduits that are also grown in sheep. For all of those xenogeneic constructs, they all have to undergo crosslinking, often with glutaraldehyde, in order to limit the immunogenicity of the product. When you do that, it becomes very difficult for the patient’s own self to repopulate, remodel, and maintain the graft. In some instances, those grafts undergo dilatation and basically flow mechanical failure because the host can’t repopulate the tissues.

In contrast, there are some autologous engineered blood vessels that have been tested in recent years. These vessels were most commonly made from the patient’s own cells. They were living constructs that were grown in vitro from a tissue biopsy from the patient. This has the obvious advantage of being autologous, but it has the disadvantage that it was necessary to grow an individual graft for each patient; the waiting time was quite long, and the expense was high.

We threaded the needle here a little bit with this product. Because it is a human product, it’s engineered from human cells and doesn’t have to be crosslinked; it’s not immunogenic. But it does not require tissue biopsy from the patient. We used a donor cell bank to grow this engineered vessel, and we then decellularize them at the end of the process. So, we’ve got a nonliving human-based tissue that doesn’t have to be cross-linked and can be remodeled by the host.

Medscape: Once the acellular vessels were engineered, how did you go about testing these in humans?

Dr Niklason: Our first interest for this study was really to document safety; that was really primarily goal number one. But we also sought to understand efficacy in terms of how well these things function for dialysis. So, in terms of the study design, we were most interested in capturing events that would have a negative impact on safety.

For example, we looked for mechanical failure, dilatation, rupture, and bleeding. We were also interested in capturing whether or not these graft provoked any immune responses in the patients. We had multiple blood draws, like panel-reactive antibodies, to determine whether or not we were synthesizing these patients against the implanted tissue. From a safety standpoint, we were very encouraged. We had no instances of true aneurysm formation or mechanical failure in these grafts, so they appear to be very mechanically robust. And we had essentially no evidence of important immunogenicity. We had no instance where the graft was rejected by the patient. It was encouraging from the standpoint of safety in these 60 patients.

The other aspect of the trial design, though, had to do with the function of the graft aside from safety. And that really spoke to blood flow rates that we observed in the graft, how well the graft responded to being punctured with needles repeatedly over weeks and months and years, whether the graft maintained mechanical integrity after all those assaults, and also propensity for infection and other forms of failure, like internal hypoplasia.

Again, from the functional standpoint, these grafts seem to function pretty well. They withstood needle puncture three times a week quite well; and, in fact, we have some histologic evidence that there’s actually healing after needle puncture, so whole cells migrate into the needle tracks and help to heal the tissue actively on an ongoing basis. We think that’s encouraging and exciting. And the blood flow rates through these grafts were quite high. They were over 1 L/min typically. This meant that they were very well suited for dialysis and could withstand the high pressures of high blood flow rates that are required for these conduits.

Medscape: These are some very promising findings, not only for nephrology but for any specialties that seek to use aspects of regenerative medicine. What is next for your group, and to what sorts of applications do you see this technology being applied elsewhere?

Dr Niklason: As far as the first part of the question, we definitely plan to proceed with the phase 3 pivotal trial where we’re doing a prospective randomized comparison head to head against a standard of care in the field, which is polytetrafluoroethylene. We anticipate beginning that trial actually pretty shortly in the coming months, and we’re very excited about that. That trial will hopefully serve as our pivotal trial to really examine the comparative efficacy of this new material vs current standard of care.

As far as what it means for regenerative medicine on the whole, I think in particular the long-term mechanical function and the repopulation of these implants by patient cells means that we may be looking at a new paradigm here. If we’re interested in replacing connective tissue in patients, it may be possible to engineer the correct matrix, which we can then implant and which then gets repopulated. Blood vessels are connective tissue, but there are many other connective tissues in the body as well—intestine, trachea, tendon, ligament, skin. There may be many instances where engineering the correct matrix in the lab and creating an acellular implant may get us to off-the-shelf tissue replacement for a variety of diseases. I personally think that’s very exciting.

6 Bodily Tissues That Can Be Regenerated Through Nutrition


It may come as a surprise to some, especially those with conventional medical training, but the default state of the body is one of ceaseless regeneration. Without the flame-like process of continual cell turnover within the body – life and death ceaselessly intertwined – the miracle of the human body would not exist. In times of illness, however, regenerative processes are overcome by degenerative ones. This is where medicine may perform its most noble feat, nudging the body back into balance with foods, herbs, nutrients, healing energies, i.e. healing intention. Today, however, drug-based medicine invariably uses chemicals that have not one iota of regenerative potential; to the contrary, they almost always interfere with bodily self-renewal in order to suppress the symptoms against which they are applied. Despite the outright heretical nature of things which stimulate healing and regeneration vis-à-vis the conventional medical system which frowns upon, or is incredulous towards, spontaneous remission in favor of symptom suppression and disease management, over the course of the past few years of trolling MEDLINE we have collected a series of remarkable studies on the topic… Nerve Regeneration – There are actually a broad range of natural compounds with proven nerve-regenerative effects. A 2010 study published in the journal Rejuvenation Research, for instance, found a combination of blueberry, green tea and carnosine have neuritogenic (i.e. promoting neuronal regeneration) and stem-cell regenerative effects in an animal model of neurodegenerative disease. [1] Other researched neuritogenic substances include: There is another class of nerve-healing substances, known as remyelinating compounds, which stimulate the repair of the protective sheath around the axon of the neurons known as myelin, and which is often damaged in neurological injury and/or dysfunction, especially autoimmune and vaccine-induced demyelination disorders. It should also be noted that even music and falling in love have been studied for possibly stimulating neurogenesis, regeneration and/or repair of neurons, indicating that regenerative medicine does not necessary require the ingestion of anything; rather, a wide range of therapeutic actions may be employed to improve health and well-being, as well. [View the first-hand biomedical citations on these neuritogenic substance visit our Neuritogenic Research page on the topic] Liver Regeneration – Glycyrrhizin, a compound found within licorice, and which we recently featured as a powerful anti-SARS virus agent, has also been found to stimulate the regeneration of liver mass and function in the animal model of hepatectomy. Other liver regenerative substances include: [view the first-hand biomedical citations on the Liver Regeneration research page] Beta-Cell Regeneration – Unfortunately, the medical community has yet to harness the diabetes-reversing potential of natural compounds. Whereas expensive stem cell therapies, islet cell transplants, and an array of synthetic drugs in the developmental pipeline are the focus of billions of dollars of research, annually, our kitchen cupboards and backyards may already contain the long sought-after cure for type 1 diabetes. The following compounds have been demonstrated experimentally to regenerate the insulin-producing beta cells, which are destroyed in insulin dependent diabetes, and which once restored, may (at least in theory) restore the health of the patient to the point where they no longer require insulin replacement. [view the first-hand biomedical citations on the Beta Cell Regeneration research page] Hormone Regeneration – there are secretagogues, which increase the endocrine glands’ ability to secrete more hormone, and there are substances that truly regenerate hormones which have degraded (by emitting electrons) into potentially carcinogenic “transient hormone” metabolites. One of these substances is vitamin C. A powerful electron donor, this vitamin has the ability to contribute electrons to resurrect the form and function of estradiol (estrogen; E2), progesterone, testosterone, for instance. [2] In tandem with foods that are able to support the function of glands, such as the ovaries, vitamin C may represent an excellent complement or alternative to hormone replacement therapy. Cardiac Cell Regeneration – Not too long ago, it was believed that cardiac tissue was uniquely incapable of being regenerated. A new, but rapidly growing body of experimental research now indicates that this is simply not true, and there is a class of heart-tissue regenerating compounds known as neocardiogenic substances. Neocardiogenic substances are able to stimulate the formation of cardiac progenitor cells which can differentiate into healthy heart tissue, and they include the following: Another remarkable example of cardiac cell regeneration is through what is known as fetomaternal trafficking of stem cells through the placenta. In a recent article we discussed the amazing process known as “fetal microchimerism” by which the fetus contributes stem cells to the mother which are capable of regenerating her damaged heart cells, and possibly a wide range of other cell types. Cartilage/Joint/Spine Regeneration – Curcumin and resveratrol have been shown to improve recovery from spinal cord injury. Over a dozen other natural compounds hold promise in this area, which can be viewed on our Spinal Cord Injury page. As far as degenerative joint disease, i.e. osteoarthritis, there are a broad range of potentially regenerative substances, with 50 listed on our osteoarthritis research page. Ultimately, regenerative medicine threatens to undermine the very economic infrastructure that props up the modern, drug-based and quite candidly degenerative medical system. Symptom suppression is profitable because it guarantees both the perpetuation of the original underlying disease, and the generation of an ever-expanding array of additional, treatment-induced symptoms. This is the non-sustainable, infinite growth model which shares features characteristic of the process of cancer itself – a model, which by its very nature, is doomed to fail and eventually collapse. Cultivating diets, lifestyles and attitudes conducive to bodily regeneration can interrupt this pathological circuit, and help us to attain the bodily freedom that is a precondition for the liberation of the human soul and spirit, as well. [1] NT-020, a natural therapeutic approach to optimize spatial memory performance and increase neural progenitor cell proliferation and decrease inflammation in the aged rat.

Treating Severe Burns in the 21st Century: Meet the Skin Gun.


Scientists from the United States have been developing a technological feat that would drastically reduce the recovery time for people experiencing severe burns and wounds. It isn’t new, per se (it has been in development for at least 5 years, building on several previous models), but it’s new (and interesting) to me. Alas.. Here we are.

Image Credit: A.D.A.M.

Traditionally, when one suffers severe second or third degree burns, doctors must go through the tedious process of grafting, where they surgically remove healthy sections of a person’s own skin and tissue which is subsequently reconstructed and replaced with the damaged skin. This process can be long, fraught and painful. There is also always the possibility looming that the body will reject the tissue taken from the donor site or it could become infected.

Meet the Skin Gun:

Credit: Nat Geo

Credit: Nat Geo

In order to bypass some of the downsides of skin grafting, scientists from all over the world have been looking for an alternative method for burn patients. In doing so, ‘The Skin Gun,’ as its called, was created. (By a team from the University of Pittsburg’s McGowan Institute for Regenerative Medicine) The technology requires that a doctor remove healthy stem cells from an undamaged area on the victims body (through a biopsy). After the stem cells are isolated, they are used in conjunction with a water-based solution, which is then sprayed on top of the burn. (similar in mechanics to an aerosol spray-paint can)

Almost immediately afterward (the process generally only takes about an hour), the wound is wrapped with a special dressing that is equipped with a set of tubes that send antibiotics, electrolytes, glucose, and amino acids to the wound. (They are pretty much an artificial version of arteries and veins, which work similarly with functions in the body)

image2

The result of a skin graft. (Source)

Within days, the stem cells successfully encourage cellular regeneration of the inflicted area, allowing the wound to heal in only a mere fraction of the time (eliminating most of the risks involved with the traditional skin grating method). Whereas, in the past, skin grafts can take several months to a year to finish in completion. Cosmetically speaking, the healed skin is still quite jarring with the latter method.

Practical Methods:

At the moment, the technique can only be used on second degree burns (and it is still quite expensive), but in the future, its usage could be increased exponentially. Perhaps even being used for reconstruction of the breast after a life-saving mastectomy. It could eventually be used to break apart scar tissue internally, ridding a person of unsightly scars.

To see the results before-and-after, this is little Zed Merrick, who burnt his chest area after dumping a hot pot of tea on himself:

zeb

MS damage repair treatment looked at by Edinburgh researchers.


New treatments that could help slow the progression of multiple sclerosis could be a step closer due to research by Edinburgh University.

In MS patients the protective layer around nerve cells in the brain, known as myelin, is broken down.

Scientists have discovered that immune cells, known as macrophages, help trigger the regeneration of myelin.

The researchers hope their work could eventually lead to the development of new drugs.

The sheath around nerves cells, made of myelin, is destroyed in MS, leaving the nerves struggling to pass on messages.

_67989720_c0020395-synapses,_artwork-spl

This leads to problems with mobility, balance and vision. There is no cure but current treatments concentrate on limiting the damage to myelin.

‘Stripped away’

Now the team at Edinburgh University has found that the immune cells, known as macrophages, can release a compound called activin-A, which activates production of more myelin.

Dr Veronique Miron, from the Medical Research Council Centre for Regenerative Medicine at the university, said: “In multiple sclerosis patients, the protective layer surrounding nerve fibres is stripped away and the nerves are exposed and damaged.

 “Start Quote

We look forward to seeing this research develop further”

Dr Susan Kohlhaas MS Society

“Approved therapies for multiple sclerosis work by reducing the initial myelin injury – they do not promote myelin regeneration.

“This study could help find new drug targets to enhance myelin regeneration and help to restore lost function in patients with multiple sclerosis.”

The study, which looked at myelin regeneration in human tissue samples and in mice, was funded by the MS Society, the Wellcome Trust and the Multiple Sclerosis Society of Canada.

The findings are published in Nature Neuroscience.

Scientists now plan to start further research to look at how activin-A works and whether its effects can be enhanced.

Dr Susan Kohlhaas, head of biomedical research at the MS Society, said: “We urgently need therapies that can help slow the progression of MS and so we’re delighted researchers have identified a new, potential way to repair damage to myelin.

“We look forward to seeing this research develop further.”

Source:BBC

 

 

 

 

Will we ever grow replacement hands?


It might seem unbelievable, but researchers can grow organs in the laboratory. There are patients walking around with body parts which have been designed and built by doctors out of a patient’s own cells.

hand

Over the past few weeks on the BBC News website we have looked at the potential for bionic body parts and artificial organs to repair the human body. Now we take a look at “growing-your-own”.

There is a pressing need. A shortage of available organs means many die on waiting lists and those that get an organ must spend a lifetime on immunosuppressant drugs to avoid rejection.

The idea is that using a patient’s own stem cells to grow new body parts avoids the whole issue of rejection as well as waiting for a donor.

Dr Anthony Atala, director of the Institute for Regenerative Medicine at the Wake Forest Baptist Medical Center in North Carolina, US, has made breakthroughs in building bladders and urethras.

He breaks tissue-building into four levels of complexity.

  • Flat structures, such as the skin, are the simplest to engineer as they are generally made up of just the one type of cell.
  • Tubes, such as blood vessels and urethras, which have two types of cells and act as a conduit.
  • Hollow non-tubular organs like the bladder and the stomach, which have more complex structures and functions.
  • Solid organs, such as the kidney, heart and liver, are the most complex to engineer. They are exponentially more complex, have many different cell types, and more challenges in the blood supply.

“We’ve been able to implant the first three in humans. We don’t have any examples yet of solid organs in humans because its much more complex,” Dr Atala told the BBC.

Bladder builders

His technique for growing bladders starts with taking a tissue sample, about half the size of a postage stamp, from the bladder that is being repaired.

Over about a month, the cells are grown in the laboratory in large quantities. Meanwhile a scaffold in the shape of the organ, or part of the organ, being replaced is built.

“We coat the scaffold, basically like creating a layer cake. We place the cells on the structure one layer at a time with the cells in the correct positions,” Dr Atala said.

The cake is then “baked” for a two weeks in an oven, which has the same conditions as the inside of the human body. The new bladder is then ready to be implanted back into the body.

Eventually the scaffold is absorbed by the body, leaving the cells in place.

Building a scaffold for the bladder is one thing, building one for the heart is far more complicated. One of the problems when you move to larger organs is the getting the blood supply to work, connecting arteries, capillaries and veins to keep the organ alive.

It is why some researchers are investigating “decellularisation” – taking an existing donated organ, stripping out the original cells and replacing them with new cells from the patient who will receive the organ.

Prof Martin Birchall, a surgeon at University College London, has been involved in a number of windpipe transplants performed in this way.

The technique starts with a donor windpipe which is then effectively put through a washing machine. Repeated cycles of enzymes and detergents break down and wash away the host cells.

What is left behind is a web of proteins, mostly collagens and elastins, which give the windpipe its structure. It would look and feel like a windpipe, just without cells – a natural scaffold.

The next steps are very similar to those for making the bladder. Stem cells are taken, this time from bone marrow, and grown in a lab before being layered onto the scaffold.

The first patient was fitted with one of these windpipes in Spain in 2008.

Prof Birchall said: “We’ve made some inroads by starting with the windpipe. We’re looking at some other tissues now like the oesophagus and diaphragm and overseas the big breakthroughs have been in building the bladder and urethra.

“Those are the areas in which immediate breakthroughs have occurred, but I see a raft of further first-in-man studies in other organs happening in the next five years.”

Heartbeat

There are already strong hints of what the next steps could be.

Five routes to a solid organ

  • Build it on a scaffold
  • Strip an old organ of cells and put new ones in their place
  • Use a “bioprinter” to built an organ layer by layer
  • Inject cells into a living organ to repair
  • Use chemicals to trigger an organ to repair itself

Dr Doris Taylor, who is about to move to the Texas Heart Institute, has used the decellurisation technique on rats’ hearts andproduced beating organs.

The cells were stripped away leaving a “ghost heart” and were then injected with heart cells. Eight days later the heart was beating, albeit at just 2% of normal heart function.

She said the technique could “absolutely” be used on any organ that had a blood supply.

She told the BBC: “It’s not science fiction any more, but moving that to more complex organs is the challenge ahead of us.”

Other groups have also produced miniature organs or “organoids”. They are not the full-blown thing, but they perform the same functions at a smaller scale.

Wake Forest researchers have produced liver organoids which can break down drugs.

Dr Atala said: “The challenge for us is – how do we scale up?”

Bioprinting, just like an office printer except it “prints” cells layer by layer, has been used to “print” a kidney.

While these findings are a very long way from making it into hospitals, if indeed they ever do, the scientists involved are convinced these techniques will come good.

“The vision has to be tempered by the past and the number of false dawns that have occurred,” Prof Birchall said.

“But I genuinely do believe stem-cell technologies and tissue engineering is going to completely transform healthcare delivery in the future.

“I see it incrementally reaching out to replace transplantation. The writing is on the wall for it to do wonderful things.”

Dr Atala said: “The strategies are out there to someday be able to target every organ in the body we are not there yet. We are nowhere near there yet.

“But the goal of the field is to keep on advancing the number of tissues that we can target.”

Of course growing a hand is even more challenging than anything being tried in laboratories so far. Will it ever be possible?

“You never say never, but certainly it’s something I will most likely not see in my lifetime,” Dr Atala concluded.

Source: BBC

Japan to offer fast-track approval path for stem cell therapies.


japan

 A retooling of Japan’s drug authorization framework, on its way to becoming law, could produce the world’s fastest approval process specifically designed for regenerative medicine. “I don’t know of any other countries that have broken out with a separate and novel system” for cellular therapies, says University College London regenerative medicine expert Chris Mason, who recently met with Japanese policymakers to discuss the law.

Japan has recently been trying to shake its ‘drug lag’, a term used to describe its historically slow review process that sometimes translates into therapies reaching the market well after they have received the green light elsewhere. But the country is now ready to speed the translation of regenerative medicine to the bedside.

The move comes in response to the potential offered by its homegrown induced pluripotent stem (iPS) cell technology, which netted Shinya Yamanaka, of the University of Kyoto, last year’s Nobel Prize in Medicine or Physiology. The government already flooded the field with more than 20 billion yen ($206 million) in a supplementary budget announced earlier this year, and it’s expected to allocate another 90 billion yen into the sector over the coming decade.

Under the Pharmaceutical Affairs Law as it currently stands, regenerative therapies, like small-molecule drugs, must undergo three phases of costly and cumbersome clinical trials to get approval by Japan’s Pharmaceutical and Medical Devices Agency.

The proposed amendments to the pharmaceutical law will create a new, separate approval channel for regenerative medicine. Rather than using phased clinical trials, companies will have to demonstrate efficacy in pilot studies of as few as ten patients in one study, if the change is dramatic enough, or a few hundred when improvement is more marginal. According to Toshio Miyata, deputy director of the Evaluation and Licensing Division at the Pharmaceutical and Food Safety Bureau in Tokyo, if efficacy can be “surmised,” the treatment will be approved for marketing. At that stage, the treatment could be approved for commercial use and, crucially for such expensive treatments, for national insurance coverage.

Phased out

With the bar for regenerative therapies dramatically lowered by requiring only limited safety and efficacy data—and essentially doing away with the need for high-powered phase 3 trials—the amendments’ architects say it will be possible to get a stem cell treatment to the market in just three years, rather than the typical six or more. The law should also give local producers of regenerative medicine an edge even over those selling stem cell therapies in South Korea, where an accelerated system has helped companies get more stem cell treatments on the market than any other country (see Nat. Med. 18, 329, 2012). “It’s bold,” says Yoshihide Esaki, director of Bio-Industry Division, a bureau of the Ministry of Economy, Trade and Industry based in Tokyo, which promoted legislation calling for the update.

Following approval, there will be a post-market surveillance period of five to seven years, after which the treatment will be evaluated again for safety and efficacy. Every patient must be entered in a registry during that period, says Miyata. If the therapies prove inefficacious or unsafe, approval can be withdrawn.

Doug Sipp worries whether post-market surveillance will turn up relevant data. Sipp, who studies regulatory issues related to stem cells at the RIKEN Center for Developmental Biology in Kobe, Japan, says that making people who receive the therapies during this period cough up even the 30% co-pay generally required under Japan’s national insurance plan “will essentially be asking patients to pay for the privilege of serving as the subjects of medical experiments.” And since the patients are paying, the studies cannot be randomized or blinded. Paying patients are also more likely to experience placebo effects, Sipp warns.

“There’s also the opportunity costs to patients,” who might be able to find better therapies elsewhere, adds Mason. “We have to make sure these therapies are safe and effective. Otherwise these regulatory routes are going to be closed.”

Despite these concerns, passage of the pre-vetted law is almost a given. Esaki says there’s a 50% chance the Japanese parliament will pass the law during the current session, ending in June. If so, it would go into effect next April. If not, scientists might have to wait until November 2014 or as late as April 2015.

Source: Nature

Printing a human kidney.


Surgeon Anthony Atala demonstrates an early-stage experiment that could someday solve the organ-donor problem: a 3D printer that uses living cells to output a transplantable kidney. Using similar technology, Dr. Atala’s young patient Luke Massella received an engineered bladder 10 years ago; we meet him onstage. Talk recorded 3 March 2011.

About the Speaker

Anthony Atala asks, “Can we grow organs instead of transplanting them?” His lab at the Wake Forest Institute for Regenerative Medicine is doing just that – engineering over 30 tissues and whole organs. Anthony Atala is the director of the Wake Forest Institute for Regenerative Medicine, where his work focuses on growing and regenerating tissues and organs. His team engineered the first lab-grown organ to be implanted into a human – a bladder – and is developing experimental fabrication technology that can “print” human tissue on demand.

In 2007, Atala and a team of Harvard University researchers showed that stem cells can be harvested from the amniotic fluid of pregnant women. This and other breakthroughs in the development of smart bio-materials and tissue fabrication technology promises to revolutionize the practice of medicine.

Source: BBC.