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Our adipose derived stem cell harvesting and isolation technique yields extremely high numbers of stem cells. In reviewing outcomes data, treatment cell numbers appear to correlate with treatment success. Our cells are actually in a type of soup called Stromal Vascular Fraction SVF which is stem cells bathed in a rich mixture of natural growth factors (Not the same as human growth factor hormone which is only one type of growth factor). Some types of orthopedic and urologic diseases appear to respond better to stem cells that are super enriched with growth factors created by administering Platelet Rich Plasma to the patient. Autologous Platelet Rich Plasma is derived from a patient's own blood drawn at the time of deployment. At CSN we do not add any foreign substances or medications to the stem cells.

Yes. Patients with uncontrolled cancer are excluded. If you have an active infection anywhere in your body you must be treated first. Severely ill patients may require special consideration. Also, anyone with a bleeding disorder or who takes blood thinning medications requires special evaluation before consideration for stem cells.

We know of no documented cases personally or in the literature where serious harm has resulted. All of our patients will be entered into a database to follow and report any adverse reactions. This information is vital to the development of stem cell science. There have been a few reports of serious complications from overseas and these are being thoroughly evaluated by epidemiologists to ascertain the facts. The International Stem Cell Society registry has over 1,000 cases currently registered and only 2% of the treatments were associated with any complications, none of which were considered serious adverse events.

Stem cells can be cryopreserved in the form of liposuction fat for prolonged periods of time. Currently, this service is outsourced to an outside provider known to have excellent quality control. Many patients have been inquiring about banking cells while they are still young since stem cell numbers drop naturally with each decade of life and some advocate obtaining and saving cells to be used later in life as needed.

Different conditions are treated in different ways and there are different degrees of success. If the goal is regeneration of joint cartilage, one may not see expected results until several months after treatment. Some patients may not experience significant improvement and others may see dramatic regeneration of damaged tissue or resolution of disease. Many of the disorders and problems that the physicians at CSN are treating represent pioneering work and there is a lack of data. FDA regulations prevent CSN from making any claims about expectations for success, however, if you are chosen for treatment, it will be explained that we believe stem cell therapy may be beneficial or in some cases that we are unsure and treatment would be considered investigational.

Adult mesenchymal stem cells are not known to cause cancer. Some patients have heard of stories of cancer caused by stem cells, but these are probably related to the use of embryonic cells (Not Adult Mesenchymal Cells). These embryonic tumors known as teratomas are rare but possible occurrences when embryonic cells are used.

No. Many are confused by this because they have heard of cancer patients receiving stem cell transplants. These patients had ablative bone marrow therapy and need stem cells to re-populate their blood and marrow. This is different from the stem cells we deploy to treat noncancerous human diseases at CSN.

No. Only adult mesenchymal stem cells are used. These cells are capable of forming bone, cartilage, fat, muscle, ligaments, blood vessels, and certain organs. Embryonic stem cells are associated with ethical considerations and limitations.

No. Only a person's own adult autologous cells are used. These are harvested from each individual and deployed back into their own body. There is no risk of contamination or risk of introduction of mammalian DNA into the treatments.

Depending on the type of treatment required, stem cells can be injected through veins, arteries, into spinal fluid, subcutaneously, or directly into joints or organs. All of these are considered minimally invasive methods of introducing the stem cells. Stem cells injected intravenously are known to seek out and find (see photo) areas of tissue damage and migrate to that location thus potentially providing regenerative healing. Intravenously injected stem cells have been shown to have the capability of crossing the blood-brain barrier to enter the central nervous system and they can be identified in the patient's body many months after deployment. Note yellow arrow showing the stem cells concentrated in the patient's hand where he had a Dupytren's contracture (Dupuytren's contracture is a hand deformity that causes the tissue beneath the surface of the hand to thicken and contract).

These adult stem cells are known as progenitor cells. This means they remain dormant (do nothing) unless they witness some level of tissue injury. It's the tissue injury that turns them on. So, when a person has a degenerative type problem, the stem cells tend to go to that area of need and stimulate the healing process. We're still not sure if they simply change into the type of injured tissue needed for repair or if they send out signals that induces the repair by some other mechanism. Suffice it to say that there are multiple animal models and a plethora of human evidence that indicates these are significant reparative cells.

Stem cells are harvested under sterile conditions using a special closed system technology so that the cells never come into contact with the environment throughout the entire process from removal to deployment. Sterile technique and antibiotics are also used to prevent infection.

Ohio Stem Cell Treatment Center patients have their fat (usually abdominal) harvested in our special sterile treatment facility under a local anesthetic. The fat removal procedure lasts approximately twenty minutes. Specially designed equipment is used to harvest the fat cells and less than 100cc of fat is required. Post operative discomfort is minimal and there is minimal restriction on activity.

Stem cell therapy relies on the body's own regenerative healing to occur. The regenerative process may take time, particularly with orthopedic patients, who may not see results for several months. In some diseases, more immediate responses are possible.

Most patients, especially those with orthopedic conditions, require only one deployment. Certain types of degenerative conditions, particularly auto-immune disease, may respond best to a series of stem cell deployments. The number and necessity of any additional treatments would be decided on a case by case basis. Financial consideration is given in these instances.

No. Only certain medical problems are currently being treated at CSN. Check our list or fill out a candidate application form on the website. All patients need to be medically stable enough to have the treatment in our facility. There may be some exceptional conditions that may eventually be treated in hospitalized patients, but that remains for the future. Some patients may be declined due to the severity of their problem. Other patients may not have conditions appropriate to treat or may not be covered by our specialists or our protocols. A waiting list or outside referral (if we know of someone else treating such a problem) might be applicable in such cases.

NO. However, the Cell Surgical Network's procedures fall under the category of physician's practice of medicine, wherein the physician and patient are free to consider their chosen course of treatment. The FDA does have guidelines about treatment and manipulation of a patient's own tissues. At CSN we meet these guidelines by providing same day treatment with the patient's own cells that undergo very minimal manipulation and are inserted during the same procedure.

Stem cells are harvested and deployed during the same procedure. Our patients undergo a minimally-invasive liposuction type of harvesting procedure by a Board Certified cosmetic surgeon in our specialized treatment facility in a Treatment Center closest to you. The harvesting procedure generally lasts a few minutes and can be done under local anesthesia. Cells are then processed and are ready for deployment within 90 minutes or less.

CSN is doing pioneer research and treatment of many diseases. All investigational data is being collected so that results will be published in peer review literature and ultimately used to promote the advancement of cellular based regenerative medicine. FDA regulations mandate that no advertising medical claims be made and that even website testimonials are prohibited.

Stem cell therapy is thought to be safe and not affect dormant cancers. If someone has had cancer that was treated and responded sucessfully, there is know reason to withhold stem cell deployment. In most cases, stem cells should not be used in patients with known active cancer.

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Conjoined twins are identical twins[1] joined in utero. An extremely rare phenomenon, the occurrence is estimated to range from 1 in 49,000 births to 1 in 189,000 births, with a somewhat higher incidence in Southwest Asia and Africa.[2] Approximately half are stillborn, and an additional one-third die within 24 hours. Most live births are female, with a ratio of 3:1.[2][3]

Two contradicting theories exist to explain the origins of conjoined twins. The more generally accepted theory is fission, in which the fertilized egg splits partially.[4] The other theory, no longer believed to be the basis of conjoined twinning,[4] is fusion, in which a fertilized egg completely separates, but stem cells (which search for similar cells) find similar stem cells on the other twin and fuse the twins together. Conjoined twins share a single common chorion, placenta, and amniotic sac, although these characteristics are not exclusive to conjoined twins, as there are some monozygotic but non-conjoined twins who also share these structures in utero.[5]

The most famous pair of conjoined twins was Chang and Eng Bunker (Thai: -, In-Chan) (18111874), Thai brothers born in Siam, now Thailand. They traveled with P.T. Barnum's circus for many years and were labeled as the Siamese twins. Chang and Eng were joined at the torso by a band of flesh, cartilage, and their fused livers. In modern times, they could have been easily separated.[6] Due to the brothers' fame and the rarity of the condition, the term "Siamese twins" came to be used as a synonym for conjoined twins.[7]

Conjoined twins are typically classified by the point at which their bodies are joined. The most common types of conjoined twins are:

Other, less common types of conjoined twins include:

There are two theories about the development of conjoined twins. The first is that a single fertilized egg does not fully split during the process of forming identical twins. The second theory is that a fusion of two fertilized eggs occurs earlier in development. Although conjoined twinning has not been linked to any environmental or genetic cause, they occur so rarely it has not been possible to draw firm conclusions.

Surgery to separate conjoined twins may range from very easy to very difficult depending on the point of attachment and the internal parts that are shared. Most cases of separation are extremely risky and life-threatening. In many cases, the surgery results in the death of one or both of the twins, particularly if they are joined at the head or share a vital organ. This makes the ethics of surgical separation, where the twins can survive if not separated, contentious. Alice Dreger of Northwestern University found the quality of life of twins who remain conjoined to be higher than is commonly supposed.[11] Lori and George Schappell and Abby and Brittany Hensel are notable examples.

The first record of separating conjoined twins took place in the Byzantine Empire in the 900s. One of the conjoined twins had already died, so surgeons attempted to separate the dead twin from the surviving twin. The result was partly successful as the remaining twin lived for three days after separation. The next case of separating conjoined twins was recorded in 1689 in Germany several centuries later.[12][13] The first recorded successful separation of conjoined twins was performed in 1689 by Johannes Fatio.[14] In 1955, neurosurgeon Harold Voris (1902-1980)[15] and his team at Mercy Hospital in Chicago performed the first successful operation to separate craniopagus twins (conjoined at the head), which resulted in long-term survival for both.[16][17][18] The larger girl was reported in 1963 as developing normally, but the smaller was permanently impaired.[19]

In 1957, Bertram Katz and his surgical team made international medical history performing the world's first successful separation of conjoined twins sharing a vital organ.[20] Omphalopagus twins John Nelson and James Edward Freeman (Johnny and Jimmy) were born in Youngstown, Ohio, on April 27, 1956. The boys shared a liver but had separate hearts and were successfully separated at North Side Hospital in Youngstown, Ohio, by Bertram Katz. The operation was funded by the Ohio Crippled Children's Service Society.[21]

Recent successful separations of conjoined twins include that of the separation of Ganga and Jamuna Shreshta in 2001, who were born in Kathmandu, Nepal, in 2000. The 197-hour surgery on the pair of craniopagus twins was a landmark one which took place in Singapore; the team was led by neurosurgeons Chumpon Chan and Keith Goh.[22] The surgery left Ganga with brain damage and Jamuna unable to walk. Seven years later, Ganga Shrestha died at the Model Hospital in Kathmandu in July 2009, at the age of 8, three days after being admitted for treatment of a severe chest infection.[23]

Infants Rose and Grace ("Mary" and "Jodie") Attard, conjoined twins from Malta, were separated in Great Britain by court order Re A (Children) (Conjoined Twins: Surgical Separation) over the religious objections of their parents, Michaelangelo and Rina Attard. The twins were attached at the lower abdomen and spine. The surgery took place in November, 2000, at St Mary's Hospital in Manchester. The operation was controversial because Rose, the weaker twin, would die as a result of the procedure as her heart and lungs were dependent upon Grace's. However, if the operation had not taken place, it was certain that both twins would die.[24][25] Grace survived to enjoy a normal childhood.[26]

In 2003, two 29-year-old women from Iran, Ladan and Laleh Bijani, who were joined at the head but had separate brains (craniopagus) were surgically separated in Singapore, despite surgeons' warnings that the operation could be fatal to one or both. Their complex case was accepted only because technologically advanced graphical imagery and modelling would allow the medical team to plan the risky surgery. Unfortunately, an undetected major vein hidden from the scans was discovered during the operation.[27] The separation was completed but both women died while still in surgery.

The Moche culture of ancient Peru depicted conjoined twins in their ceramics dating back to 300 CE.[28] Writing around 415 CE, St. Augustine of Hippo, in his book, City of God, refers to a man "double in his upper, but single in his lower half--having two heads, two chests, four hands, but one body and two feet like an ordinary man."[29]

According to Theophanes the Confessor, a Byzantine historian of the 9th century, around 385/386 CE, "in the village of Emmaus in Palestine, "a child was born perfectly normal below the navel but divided above it, so that it had two chests and two heads, each possessing the senses. One would eat and drink but the other did not eat; one would sleep but the other stayed awake. There were times when they played with each other, when both cried and hit each other. They lived for a little over two years. One died while the other lived for another four days and it, too, died."[30]

In Arabia, the twin brothers Hashim ibn Abd Manaf and 'Abd Shams were born with Hashim's leg attached to his twin brother's head. Legend says that their father, Abd Manaf ibn Qusai, separated his conjoined sons with a sword and that some priests believed that the blood that had flowed between them signified wars between their progeny (confrontations did occur between Banu al'Abbas and Banu Ummaya ibn 'Abd Shams in the year 750 AH).[31] The Muslim polymath Ab al-Rayhn al-Brn described conjoined twins in his book Kitab-al-Saidana.[32]

The English twin sisters Mary and Eliza Chulkhurst, who were conjoined at the back (pygopagus), lived from 1100 to 1134 (or 1500 to 1534) and were perhaps the best-known early historical example of conjoined twins. Other early conjoined twins to attain notice were the "Scottish brothers", allegedly of the dicephalus type, essentially two heads sharing the same body (14601488, although the dates vary); the pygopagus Helen and Judith of Szny, Hungary (17011723), who enjoyed a brief career in music before being sent to live in a convent; and Rita and Cristina of Parodi of Sardinia, born in 1829. Rita and Cristina were dicephalus tetrabrachius (one body with four arms) twins and although they died at only eight months of age, they gained much attention as a curiosity when their parents exhibited them in Paris.

Several sets of conjoined twins lived during the nineteenth century and made careers for themselves in the performing arts, though none achieved quite the same level of fame and fortune as Chang and Eng. Most notably, Millie and Christine McCoy (or McKoy), pygopagus twins, were born into slavery in North Carolina in 1851. They were sold to a showman, J.P. Smith, at birth, but were soon kidnapped by a rival showman. The kidnapper fled to England but was thwarted because England had already banned slavery. Smith traveled to England to collect the girls and brought with him their mother, Monimia, from whom they had been separated. He and his wife provided the twins with an education and taught them to speak five languages, play music, and sing. For the rest of the century, the twins enjoyed a successful career as "The Two-Headed Nightingale" and appeared with the Barnum Circus. In 1912, they died of tuberculosis, 17 hours apart.

Giovanni and Giacomo Tocci, from Locana, Italy, were immortalized in Mark Twain's short story "Those Extraordinary Twins" as fictitious twins Angelo and Luigi. The Toccis, born in 1877, were dicephalus tetrabrachius twins, having one body with two legs, two heads, and four arms. From birth they were forced by their parents to perform and never learned to walk, as each twin controlled one leg (in modern times, physical therapy allows twins like the Toccis to learn to walk on their own). They are said to have disliked show business. In 1886, after touring the United States, the twins returned to Europe with their family, where they fell ill. They are believed to have died around this time, though some sources claim they survived until 1940, living in seclusion in Italy.

Link:
Conjoined twins - Wikipedia

LIMA A chiropractic center that specializes in treating chronic pain is now offering regenerative stem cell therapy, a new healing procedure that is the first of its kind in the area.

Modern Health & Wellness, located at 2425 Allentown Road, has partnered with Ohio Stem Cell and the Stem Cell Institute of America to bring this procedure to the region. According to Ohio Stem Cells doctors, patients can experience a significant decrease in pain and an improvement in range of motion within weeks of one treatment.

The research behind this technology is showing amazing results, said Modern Health & Wellness owner Dr. Patrick Gorman. In time, its our hope that this truly amazing therapy will eliminate the need for drugs and surgery.

Ohio Stem Cell doctors will be on site to administer the regenerative stem cell therapy, which has been approved by the Food and Drug Administration. Gorman said painless stem cell injections will help with arthritic and/or degenerative conditions, especially those found in the knees, hips, shoulders, neck and lower back.

These treatments can repair tissue in the body that has been damaged from age, disease or degeneration. It is accomplished by pinpointing the impaired areas, removing the swelling with anti-inflammatory properties and healing them by regenerating new cells and tissue.

This type of therapy is particularly effective in treating conditions such as degenerative arthritis, degenerative cartilage and ligaments, bone spurs, degenerative joint disease, bursitis and tendinitis.

Stem cell injections and therapy can help people that have bone-on-bone arthritis in their knee, and it can actually regenerate the tissue like the cartilage and the meniscus to help heal that area and allow people to go back to activities and function like they did before, Gorman said.

For those who may be concerned that stem cell therapy is against their religious beliefs, Gorman said it is illegal in the United States to obtain stem cells via an abortion.

The clinics that are harvesting these stem cells actually have to demonstrate and prove beyond a shadow of a doubt that these have been harvested via a successful C-section, he said. No babies are being aborted to obtain these cells.

Gorman added that anyone who is thinking of undergoing regenerative stem cell therapy should set up a consultation at the wellness center, or attend monthly lectures on this topic. The lectures are provided two to three times a month at the Area Agency on Aging 3, which is located in the same building as the wellness center.

We have a lot of people attend those lectures, and its mainly there to help educate people and explain to them what stem cell has done in the past, and what it can do for you, he said.

The next lecture is scheduled for 10 a.m. Sept. 9 at AAA3. Another lecture will be held at 10 a.m. Sept. 23.

Dr. Patrick Gorman, owner of Modern Health & Wellness in Lima, speaks to attendees at a ribbon-cutting ceremony celebrating the centers newly implemented regenerative stem cell therapy on Thursday.

Reach John Bush at 567-242-0456 or on Twitter @Bush_Lima.

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Modern Health & Wellness of Lima institutes regenerative stem cell therapy - Lima Ohio

ClinicalTrials.gov, the federal governments public listing of medical trials, is providing false comfort to consumers and free advertising to for-profit stem-cell clinics offering unproven and loosely regulated treatments, a Sun Sentinel investigation has found.

Patients typically assume trials on the site must have government oversight and be carefully vetted.

They are wrong.

An official of the National Institutes of Health, which oversees the agency that operates ClinicalTrials.gov, confirmed that it does not verify information submitted for posting. Nor does it approve the trials listed, check the qualifications of those who run them, or monitor their results.

Yet unsuspecting patients, many facing diseases without traditional treatments or cures, routinely scour the site in search of experimental options. Their doctors encourage them to use ClinicalTrials.gov. So does the U.S. Food and Drug Administration.

Experts say some for-profit stem-cell clinics are exploiting ClinicalTrials.gov as a powerful marketing tool and putting at risk patients who assume their trials are government-approved.

The cases of three women who had severe vision loss following injections at a Sunrise stem-cell clinic have cast scrutiny on the issue. All three traveled to South Florida for treatments at U.S. Stem Cell, and two said they heard about the clinic from its listing on ClinicalTrials.gov.

Florida is a hotspot for for-profit stem-cell clinics. A 2016 report by two professors on the growing number of these clinics nationwide found California had the most with 113, followed closely by Florida with 104. The third-highest was Texas, with 71.

Stem cells are considered one of medicines most promising tools because they have the unique capacity to regenerate and repair damaged tissue. Major U.S. universities and research institutions are exploring cutting-edge stem-cell treatments under established medical protocols.

But this medical frontier has also spawned a cottage industry of for-profit stem-cell clinics that operate with little oversight. They specialize in procedures that slide through an FDA regulatory loophole because they use a patients own cells, extracted from one part of the body and injected into another, in a process that takes no more than one day.

Listings of their trials can be found alongside those of universities, major research institutions and FDA-regulated studies on ClinicalTrials.gov. But their practices may be far different.

Some of these clinics charge thousands of dollars for treatments, unlike most traditional trials that are free to patients. Some dont follow up with patients or collect treatment results data, as is standard in true research trials. Some use the same procedure to treat a variety of maladies, like multiple sclerosis, erectile dysfunction and chronic lung disease.

Patients will find them all on ClinicalTrials.gov.

ClinicalTrials.gov runs on an honor system, said Dr. Michael Carome, health research group director for the nonprofit consumer advocacy group Public Citizen.

While the vast majority of ClinicalTrials.gov listings involve regulated research, Carome said he finds it deeply troubling that a well-intentioned consumer resource is being repurposed by some to promote unproven medical care.

Carrie Wolinetz, associate director for science policy at the National Institutes of Health, said it is the responsibility of those who submit information to ClinicalTrials.gov to be transparent.

They basically are declaring the information is true when they submit the application, Wolinetz said.

She said the NIH agency, the National Library of Medicine, does not have the money, staff or expertise to approve registrations or study results submitted by scientists and researchers.

Some stem-cell clinics listed on ClinicalTrials.gov market themselves as NIH-registered. That doesnt mean they are approved or monitored by the NIH.

The NIH monitors only the trials it funds, Wolinetz said. The FDA monitors trials it regulates.

Private trials without government oversight or funding, including those of for-profit stem-cell clinics, are required to list an Institutional Review Board on ClinicalTrials.gov. These boards are composed of industry professionals hired by the study runners to oversee protocols and progress.

Experts like Paul Knoepfler, a biomedical scientist and frequent blogger on the for-profit stem-cell industry, have questioned the quality of IRBs that serve the stem-cell industry.

Todays bottom line, unfortunately, is that IRB approval of experimental for-profit stem-cell offerings that lack FDA approval may in some cases carry very little weight on its own, Knoepfler, from the University of California, Davis, wrote in March.

He advised patients not to assume IRB approval means a trial is well-run and to ask serious questions about the boards history and track record.

Earl Stringer traveled from his home in Ohio to South Florida for a procedure he saw on ClinicalTrials.gov.

When you go to the website, you think its government-backed. I thought, wow, this is a real solution, he said.

Stringer, 35, was looking to regain vision he had been slowly losing since he was born with optic atrophy. He signed up for the Stem Cell Ophthalmology Treatment Study, a collaboration of a Connecticut-based company called MD Stem Cells and Dr. Jeffrey Weiss, a Margate, Fla., ophthalmologist.

While the MD Stem Cells website says the study is NIH-registered, it is not government-approved or -regulated. The site also says the trial is the largest and most comprehensive stem-cell eye study registered with (NIH).

Weiss said he doesnt need government approval, and his study and results are reviewed by an independent panel that is FDA-monitored. He said he has done stem-cell procedures for eye disease on about 500 patients.

I am using peoples own stem cells. I dont need the FDAs approval, Weiss said.

With others in the stem-cell industry, Weiss said his clinic is helping seriously ill people by offering cutting-edge medicine that would take years to come to market under the FDAs standard trial path. FDA approval requires years of studies showing a treatment is safe and effective.

Stringer, a fitness trainer, Stringer said he borrowed $19,000 from his family for the treatments. In June 2016, he had his own stem cells injected into both of his eyes by Weiss. He said he was disappointed that his vision did not improve and that he now constantly sees spots in his right eye. He stopped sending Weiss the follow-up reports required for the trial.

I thought, Ive wasted my money, he said.

Weiss said Stringers vision had improved when he last saw him, but that none of his patients are told that success is certain.

Weiss said his trial follows proper scientific standards, that he is doing research and publishing papers in medical journals.

There are four peer-reviewed articles attached to his eye studys listing on the website.

Three involve case results from individual patients. A fourth involves a five-patient group.

Vanna Belton, a 30-year-old, Baltimore-area restaurant owner who was almost legally blind, said she was one of those patients profiled. Belton said she dramatically regained much of her vision following her 2014 procedure.

She found the study on ClinicalTrials.gov. For Belton, the studys inclusion on the website meant it was NIH-approved, assuring her the trial was not a for-profit, back-alley clinic selling false promises, she said.

The trial Stringer and Belton participated in was one of 18 cited in a recent analysis that concluded some for-profit stem-cell clinics are using ClinicalTrials.gov to attract customers with the suggestion they are doing government-sanctioned research.

The report, by University of Minnesota bioethicist Leigh Turner and published in the peer-reviewed medical periodical Regenerative Medicine, looked at autologous adult stem-cell therapy trials that he believed required patients to pay for treatment. Twelve had a site in Florida. He found them using search terms online, including patient-funded, patient-sponsored and self-funded.

Experts say charging patients thousands of dollars to participate in a clinical study often is a red flag. Studies traditionally have been funded through drug companies, the government or private grants. Turner found some trials disclosed upfront that there were participation fees but others did not.

They have repurposed the NIHs site as a marketing device, he said. You can see its a powerful technique. Its intelligent and it works.

Duncan Ross, an immunologist who founded Kimera Labs in Miramar, also was included in Turners report. He charges lung disorder patients $7,000 to $10,000 but said he created the nonprofit Kimera Society to help finance needy patients.

To those who criticize clinics that charge for treatments, Ross would say he sees little difference between patients subsidizing research and taxpayer dollars going to NIH-funded studies at universities.

New federal guidelines are being phased in this year to help determine who is responsible for whats on ClinicalTrials.gov and what information must be posted. They would also add penalties for noncompliance and strengthen rules about reporting participants injuries.

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Government website steers patients to unproven medical treatments - MyAJC

La Jollas fabled Salk Institute says its in great financial shape. Just two years ago, it raised a record $361 million in private donations far exceeding its goal.

But a short time later, the Salk noted in private documents that it still faces daunting money issues that come as it tries to preserve the singular approach it takes to studying human disease.

Like other biomedical research institutes, the Salk is under great pressure to develop discoveries to the point where they will attract big money from drug companies, the government and appreciative donors.

The people who underwrite science say scientists can and must speed up the process of finding ways to alleviate suffering.

The 57-year-old Salk has long preferred to focus on more basic questions about how and why disease occurs work that has aided in the creation of such cancer drugs as Gleevec and Iressa. Its painstaking research that doesnt always have a clear payoff, and can make it hard to compete for money.

The challenge comes as the Salk is coping with the fallout from three of its female professors filing lawsuits that accuse the institute of gender discrimination. The suits, filed in July, say the Salk favors men when it comes to pay, promotions, grants and leadership opportunities.

The allegations have been staunchly denied by Salk President Elizabeth Blackburn, a Nobel laureate.

The matter was further complicated on Friday when Ted Waitt, the billionaire who chairs the Salks board of trustees, unexpectedly announced that he will leave the position in November for personal reasons.

Waitt played a key role in helping the Salk raise $361 million in private donations during a capital campaign that ended in 2015. His announcement came a day before the institute holds Symphony for Salk, a community-building concert held every August.

Theres broad agreement that the Salk, which is determined to remain small, needs to raise a lot more money for everything from recruiting faculty to buying pricey scientific equipment.

Despite the success of the recent capital campaign, there are significant and daunting financial challenges facing the institute, many which need to be addressed through increased private philanthropy, the Salk says in internal documents obtained by the Union-Tribune.

Documents: Salk Finances

The documents also show that, over the past couple of years, the Salk has considered a number of provocative ideas for dealing with the issue, including:

The Salk told the Union-Tribune on Thursday, The document leaked to you includes the preliminary brainstorming of several individuals holding various positions within Salk, including a number not serving in faculty or management roles, who were invited to present a wide-range of ideas for early consideration.

In no way is it equivalent to a strategic plan, which remains in development. It is simply a collection of initial thoughts.

Without question, the Salk Institute, in many ways, is now in the best financial and operational position it has ever been. It is entirely inaccurate and irresponsible to suggest otherwise.

The institute added that it decided not to pursue a short-term endowment campaign, a hospital affiliation, or a name change.

The Salk is charting its future at a moment when its scientific neighbors in La Jolla are rapidly expanding in translational medicine, the term for turning discoveries into drugs and therapies.

Theyre being driven, in part, by big donors who want scientists to shorten the time it takes to develop treatments for everything from dementia and cancer to diabetes, spinal cord injuries and aging.

The demand has been pressed especially hard by donors like T. Denny Sanford, who gave UC San Diego $100 million in 2013 to speed up the quest to find ways to use stem cells to treat a variety of afflictions.

Sanford said, It is time to move stem cell research from animals into humans for trials, especially in areas like ALS (Lou Gehrigs disease) and spinal cord injuries, where I believe we can make a lot of progress.

His gift helped the university create a seven-story translational medicine building thats physically linked to the new Jacobs Medical Center to make it easier for researchers and clinicians to collaborate.

Researchers there are doing such things as using smartphones to help determine the severity of cystic fibrosis in patients, and developing devices similar to the medical tri-corder seen in Star Trek.

The new building also has enabled UC San Diego to carry out drug trials, which helped the university raise a record $1.12 billion in research funding last year. And it helped the campus recruit such star scientists as Jeremy Rich, a brain tumor specialist who came from the Cleveland Clinic in Ohio.

A lot of people think that taking an idea or discovery from lab to clinic is simple. Its not; its almost impossibly difficult and exhausting, said Gary Firestein, the universitys associate vice chancellor of translational medicine.

The problem isnt just the science, but also the regulatory maze that stands between scientist and patient, he added. Translational medicine was invented to somehow bridge that gap.

The struggle has been playing out at places like The Scripps Research Institute (TSRI) in La Jolla, which is led by CEO Peter G. Schultz, an accomplished chemist also at home in the business world.

Schultz brought in an affiliate called Calibr to advance research to the clinical trial stage, where therapies are first tested in people. At that point much of the risk in development is gone, and drug companies will pay more to license products.

Earlier this year, Schultz revamped TSRIs board of directors to include more biomedical and business leaders and wealthy individuals. This high-powered board provides not only more credibility, but has members with money to make large donations themselves.

If Schultz achieves his goals, the institute will greatly speed up its pipeline of therapies from the laboratory bench to the patients bedside. That means patients will get new therapies faster and TSRI will get more money to continue churning out discoveries.

The Salk Institute faces pressure to do likewise, or be left behind. And it clearly sees this as a pivotal moment in its history. The institute summed up the challenge in a document obtained by the Union-Tribune.

A part of the document asks, simply: How do we make sure Salk is financially prepared to continue to be a leader in biological research?

For further reading

Salk board chairman stepping down amid institute turmoil

Salk president softens criticism of 2 faculty who sued for gender discrimination

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The research has implications for people with diabetes-induced ischemia and stroke.

Nancy Crotti

Researchers have developed tissue nanotransfection, a process for regrowing tissue inside the human body.

Researchers at Ohio State University have developed breakthrough stem cell technology that can regrow tissue inside the human body, rather than in a laboratory.

Their work has implications for critical limb ischemia, brain disorders, and possibly even organ engineering and bone regrowth, according to Chandan Sen, PhD, director of the Center for Regenerative Medicine and Cell-Based Therapies at Ohio States Wexner Medical Center in Columbus. Sen led the team that developed the technology.

Heres how the process, known as nanotransfection, works: The scientists make synthetic RNA and DNA to match that of the patient. They load it into nanochannels inside tiny needles embedded in a chip and apply the chip to the skin. The needles electrocute about 2% of the cell surface with the patients nucleic acid. The procedure takes 1/10th of a second, and has been shown to work with up to 98% efficiency.

In experiments on mice, the technology restored blood flow to injured legs by reprogramming the animals skin cells to become vascular cells. With no other form of treatment, active blood vessels had formed within two weeks, and by the third week, blood flow returned and the legs of the mice were saved.

The researchers also induced strokes in mice and used the chips to grow new brain tissue from the animals skin and transplant it to their brains. Bodily function damaged by the strokes was restored. The study of the technique, which worked with up to 98% efficiency, was reported in the journal Nature Nanotechnology.

The technology marks an advance over cell regeneration conducted in a laboratory, because those cells mostly underperform or die once transplanted into the body, according to Sen. The researchers use skin cells in their work because, as Sen explained, everybody has some to spare.

We grow it in you and we move it over to the organ so you have your own cells populating your organ, he said. Its all coming from you.

The synthetic RNA and DNA reprogram cells in the same way that fetal cells develop different functions to become different body parts, Sen added. The researchers worked on the technology for more than four years, also conducting successful blood flow restoration experiments on pigs. When they begin human trials, their first patients will likely be those whose critical limb ischemic has reached the stage where amputation is the only option.

The scientists work has generated interest in Europe, Asia, the Middle East, and in the United States. Ohio State will decide where to pursue human trials first, and is searching for industry partners.

The cost is extremely low and complexity-wise it is extremely low. I see very little barrier to take it to humans, Sen said.

The researchers work marks another interface between silicon chips and biology. Other applications picked up by manufacturers include DNA sequencing machines, miniaturized diagnostic tests using disposable photonic chips, accurate body monitoring sensors, and brain stimulation probes.

Sen and his team acknowledge that their work will be met with skepticism.

Whenever you do something that is sort of transformative, you will expect that, Sen said. Therefore, we actually published this in the most rigorous journal possible. We went through 16 months of criticism and response, after which this was published.

Nancy Crotti is a freelance contributor to MD+DI.

[Image courtesy of THE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER]

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'Nanotransfection' Turns Animal Skin into Blood Vessels and Brain ... - Medical Device and Diagnostics Industry

It sounds like science fiction: with a light zap of electricity, a tiny stamp-like device transforms your skin cells into reservoirs of blood vessels or brain cells, ready to heal you from within.

Recently, a team of medical mavericks at the Ohio State University introduced a device that does just that. The technology, dubbed tissue nanotransfection (TNT), is set to blow up the field of organ regeneration.

When zapped with a light electrical jolt, the device shoots extra bits of DNA code from its nanotube arrays directly into tiny pores in the skin. There, the DNA triggers the cells to shed their identity and reprograms them into other cell types that can be harvested to repair damaged organs.

Remarkably, the effect spreads with time. The rebooted cells release tiny membrane bubbles onto their neighboring skin cells, coaxing them to undergo transformation. Like zombies, but for good.

So far, the device has already been used to generate neurons to protect the brains of mice with experimental stroke. The team also successfully healed the legs of injured mice by turning the skin cells on their hind limbs into a forest of blood vessels.

While still a ways from human use, scientists believe future iterations of the technology could perform a myriad of medical wonders: repairing damaged organs, relieving brain degeneration, or even restoring aged tissue back to a youthful state.

By using our novel nanochip technology, injured or compromised organs can be replaced. We have shown that skin is a fertile land where we can grow the elements of any organ that is declining, says lead author Dr. Chandan Sen, who published the result in Nature Nanotechnology.

In my lab, we have ongoing research trying to understand the mechanism and do even better, adds Dr. L. James Lee, who co-led the study with Sen. So, this is the beginning, more to come.

The Ohio teams research builds on an age-old idea in regenerative medicine: that even aged bodies have the ability to produce and integrate healthy, youthful cellsgiven the right set of cues.

While some controversy remains on whether replacement cells survive in an injured body, scientistsand some rather dubious clinicsare readily exploring the potential of cell-based therapies.

All cells harbor the same set of DNA; whether they turn into heart cells, neurons, or back into stem cells depend on which genes are activated. The gatekeeper of gene expression is a set of specialized proteins. Scientists can stick the DNA code for these proteins into cells, where they hijack its DNA machinery with orders to produce the protein switchesand the cell transforms into another cell type.

The actual process works like this: scientists harvest mature cells from patients, reprogram them into stem cells inside a Petri dish, inject those cells back into the patients and wait for them to develop into the needed cell types.

Its a cumbersome process packed with landmines. Researchers often use viruses to deliver the genetic payload into cells. In some animal studies, this has led to unwanted mutations and cancer. Its also unclear whether the reprogrammed stem cells survive inside the patients. Whether they actually turn into healthy tissue is even more up for debate.

The Ohio teams device tackles many of these problems head on.

Eschewing the need for viruses, the team manufactured a stamp-sized device out of silicon that serves as a reservoir and injector for DNA. Microetched onto each device are arrays of nanochannels that connect to microscopic dents. Scientists can load DNA material into these tiny holding spots, where they sit stably until a ten-millisecond zap shoots them into the recipients tissue.

We based TNT on a bulk transfection, which is often used in the lab to deliver genes into cells, the authors explain. Like its bulk counterpart, the electrical zap opens up tiny, transient pores on the cell membrane, which allows the DNA instructions to get it.

The problem with bulk transfection is that not all genes get into each cell. Some cells may get more than they bargained for and take up more than one copy, which increases the chance of random mutations.

We found that TNT is extremely focused, with each cell receiving ample DNA, the authors say.

The device also skips an intermediary step in cell conversion: rather than turning cells back into stem cells, the team pushed mouse skin cells directly into other mature cell types using different sets of previously-discovered protein factors.

In one early experiment, the team successfully generated neurons from skin cells that seem indistinguishable from their natural counterparts: they shot off electrical pulses and had similar gene expression profiles.

Surprisingly, the team found that even non-zapped cells in the skins deeper layers transformed. Further testing found that the newly reprogrammed neurons released tiny fatty bubbles that contained the molecular instructions for transformation.

When the team harvested these bubbles and injected them into mice subjected to experimental stroke, the bubbles triggered the brain to generate new neurons and repair itself.

We dont know if the bubbles are somehow transforming other brain cell types into neurons, but they do seem to be loaded with molecules that protect the brain, the researchers say.

In an ultimate test of the devices healing potential, the researchers placed it onto the injured hind leg of a handful of mice. Three days prior, their leg arteries had been experimentally severed, whichwhen left untreatedleads to tissue decay.

The team loaded the device with factors that convert skin cells into blood vessel cells. Within a week of conversion, the team watched as new blood vessels sprouted and grew beyond the local treatment area. In the end, TNT-zapped mice had fewer signs of tissue injury and higher leg muscle metabolism compared to non-treated controls.

This is difficult to imagine, but it is achievable, successfully working about 98 percent of the time, says Sen.

A major draw of the device is that its one-touch-and-go.

There are no expensive cell isolation procedures and no finicky lab manipulations. The conversion happens right on the skin, essentially transforming patients bodies into their own prolific bioreactors.

This process only takes less than a second and is non-invasive, and then youre off. The chip does not stay with you, and the reprogramming of the cell starts,says Sen.

Because the converted cells come directly from the patient, theyre in an immune-privileged position, which reduces the chance of rejection.

This means that in the future, if the technology is used to manufacture organs immune suppression is not necessary, says Sen.

While the team plans to test the device in humans as early as next year, Sen acknowledges that theyll likely run into problems.

For one, because the device needs to be in direct contact with tissue, the skin is the only easily-accessible body part to do these conversions. Repairing deeper tissue would require surgery to insert the device into wounded areas. And to many, growing other organ cell types is a pretty creepy thought, especially because the transformation isnt completely localnon-targeted cells are also reprogrammed.

That could be because the body is trying to heal itself, the authors hypothesize. Using the chip on healthy legs didnt sprout new blood vessels, suggesting that the widespread conversion is because of injury, though (for now) there isnt much evidence supporting the idea.

For another, scientists are still working out the specialized factors required to directly convert between cell types. So far, theyve only had limited success.

But Sen and his team are optimistic.

When these things come out for the first time, its basically crossing the chasm from impossible to possible, he says. We have established feasibility.

Image Credit: Researchers demonstrate tissue nanotransfection,courtesy of The Ohio State University Wexner Medical Center.

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Misericordia University welcomed 436 first-year students to campus during the annual convocation ceremony on Thursday, Aug. 24 in the Wells Fargo Amphitheater. The class is the third largest in school history.

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A convocation ceremony was held at Misericordia University on Thursday, welcoming members of the freshman class.

Submitted photos

DALLAS TWP. With a processional led by a contingent of bagpipers, Misericordia University welcomed 436 first-year students, the third largest class in school history, during the annual convocation ceremony on Thursday in the Wells Fargo Amphitheater. Misericordia University received 2,397 applications for the first-year class, which hails from 13 states, including Connecticut, Delaware, Florida, Illinois, Indiana, Maryland, Massachusetts, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington.

The university also welcomed 75 transfer students. With the new class of students, the university expects to have between 2,750-2,775 undergraduate and graduate students in full- and part-time academic programs for the fall semester. Misericordia has 960 students scheduled to live in residence halls and townhomes on campus.

The convocation program included a welcome by President Thomas J. Botzman, Ph.D., and an address by alumnus Tariq Adwan 05, Ph.D., chief scientific officer of Alpha Genomix of Lawrenceville, Georgia, a member of the Class of 2005.

During the ceremony, the Misericordia University Alumni Association presented Dr. Adwan with the Young Alumnus Award. The award is bestowed, from time to time, to a traditional undergraduate alumna or alumnus who has graduated within the past ten years and who has demonstrated outstanding professional achievements and/or community or civic service.

In his address, the native of Palestine talked about how Dr. Carol Rittner, RSM, a member of the Misericordia Board of Trustees, was instrumental in his decision to make the 10,000-mile trip from his home on the West Bank to the Misericordia campus in 2001. Dr. Rittner, a chaired scholar of Holocaust studies at Stockton State University, had met Dr. Adwans father, who, with a colleague of the Jewish faith, was working in support of the Middle East peace process.

Although my interaction with Sister Carol at the time was relatively brief, she expressed enough compassion, selflessness, acceptance and respect that it did not take much thought before I decided that Misericordia was where I wanted to spend the next four years of my life, Dr. Adwan said of his decision. He was a student at Misericordia for only three weeks when terrorists attacked the United States on Sept. 11.

Being the only Muslim student on campus at the time, I was devastated. I was afraid and I even contemplated going back to Palestine for fear of retaliation. Much to my surprise, by the evening of that day, my dorm room was filled with fellow students where we gathered in solidarity with the victims and their families as we tried to make sense of what just happened.

Needless to say, what I experienced that night left a lasting impression on me, and the friendships I have made were nothing like I have ever experienced before or since, he stated. I realized that day, that changing the world was possible, but that I needed people to do it with.

So as you embark on your journey I encourage you to get to know as many people that are different from you as possible. Engage in face-to-face interaction with them and you will find that the people that are most different from you are those that will inspire you the most. You will also find that even though these people may seem different from you, they are, after all, people just like you.

He added, Share your story; it matters. You might be a first-generation college student or a first-generation immigrant Whoever you are and whatever your story might be, it is a chapter in the American story that makes us who we are. When we know who we are, we realize that we are a nation of all creeds, colors, races and national origins. It is then that we become less threatened and more welcoming of the stranger. For we, once upon a time, were the strangers.

As a Misericordia sophomore, Adwan participated in designing and helping prepare an experiment that was placed on the 16-day Columbia shuttle mission. Growth of Bacterial Biofilm on Surfaces During Spaceflight was done under the direction of the Israeli Aerospace Medical Institute and Johnson Space Center Astrobiology Center. It combined a proposal from Adwan, submitted from his Misericordia residence hall, and another from Yuval Landau, a student at Tel Aviv University. Sadly, the shuttle broke up on re-entry and all members of the crew, including the first Israeli astronaut, were killed on Feb. 1, 2003.

Adwan holds a Bachelor of Science degree in biology and chemistry with honors from Misericordia, and a Ph.D. in cell biology from the University of Colorado, Denver, Colorado, specializing in stem cells and development. As chief scientific officer at Alpha Genomix, he oversees all scientific, technological and research operations, and helps identify new opportunities for growth with industry partners. Alpha Genomix is a personalized medicine testing and molecular diagnostics laboratory for pharmacogenetics, the field of research on how a persons genetic makeup affects that individuals response to medications and drugs. He is also an adjunct faculty member at Georgia Gwinnet College, Lawrenceville, Georgia, where he teaches biology.

The annual convocation ceremony welcomes first-year students and their families to Misericordia University, and acts as the official start to the new academic year. Orientation begins later in the afternoon and continues until the first day of class on Aug. 28. The orientation program includes the Orientation Days of Service on Aug. 26-27 in which first-year students and other members of the campus community volunteer in the region.

Misericordia University welcomed 436 first-year students to campus during the annual convocation ceremony on Thursday, Aug. 24 in the Wells Fargo Amphitheater. The class is the third largest in school history.

A convocation ceremony was held at Misericordia University on Thursday, welcoming members of the freshman class.

Freshman class is third largest in school history

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This year's freshman class at Misericordia University is third largest in school history - The Dallas Post

A novel device that reprograms skin cells could represent a breakthrough in repairing injured or aging tissue, researchers say. The new technique, called tissue nanotransfection, is based on a tiny device that sits on the surface of the skin of a living body. An intense, focused electric field is then applied across the device, allowing it to deliver genes to the skin cells beneath it -- turning them into different types of cells.

That, according to the researchers, offers an exciting development when it comes to repairing damaged tissue, offering the possibility of turning a patient's own tissue into a "bioreactor" to produce cells to either repair nearby tissues, or for use at another site.

"By using our novel nanochip technology, injured or compromised organs can be replaced," said Chandan Sen [pictured above], from the Ohio State University, who co-led the study. "We have shown that skin is a fertile land where we can grow the elements of any organ that is declining."

The ability for scientists to reprogram cells into other cell types is not new: the discovery scooped John Gurdon and Shinya Yamanaka the Nobel Prize in 2012 and is currently under research in myriad fields, including Parkinson's disease.

"You can change the fate of cells by incorporating into them some new genes," said Dr Axel Behren, an expert in stem cell research from the Francis Crick Institute in London, who was not involved in the Ohio research. "Basically you can take a skin cell and put some genes into them, and they become another cell, for example a neuron, or a vascular cell, or a stem cell."

But the new approach, says Sen, avoids an intermediary step where cells are turned into what are known as pluripotent stem cells, instead turning skin cells directly into functional cells of different types. "It is a single step process in the body," he said.

Furthermore, the new approach does not rely on applying an electric field across a large area of the cell, or the use of viruses to deliver the genes. "We are the first to be able to reprogram [cells] in the body without the use of any viral vector," said Sen.

The new research, published in the journal Nature Nanotechnology, describes how the team developed both the new technique and novel genes, allowing them to reprogramme skin cells on the surface of an animal in situ.

"They can put this little device on one piece of skin or onto the other piece of skin and the genes will go there, wherever they put [the device]," said Behrens.

The team reveal that they used the technique on mice with legs that had had their arteries cut, preventing blood flow through the limb. The device was then put on the skin of the mice, and an electric field applied to trigger changes in the cells' membrane, allowing the genes to enter the cells below. As a result, the team found that they were able to convert skin cells directly into vascular cells -with the effect extending deeper into the limb, in effect building a new network of blood vessels.

"Seven days later we saw new vessels and 14 days later we saw [blood flow] through the whole leg," said Sen.

The team were also able to use the device to convert skin cells on mice, into nerve cells which were then injected into the brains of mice who had experienced a stroke, helping them to recover.

"With this technology, we can convert skin cells into elements of any organ with just one touch. This process only takes less than a second and is non-invasive, and then you're off," said Sen.

The new technology, said Behrens is an interesting step, not least since it "avoids all issues with rejection".

"This is a clever use of an existing technique that has potential applications -- but massive further refinement is needed," he said, pointing out that there are standard surgical techniques to deal with blockages of blood flow in limbs.

What's more, he said, the new technique is unlikely to be used on areas other than skin, since the need for an electric current and the device near to the tissue means using it on internal organs would require an invasive procedure.

"Massive development [would be] needed for this to be used for anything else than skin," he said.

But Sen and colleagues say they are hoping to develop the technique further, with plans to start clinical trials in humans next year.

2017 Guardian Web under contract with NewsEdge/Acquire Media. All rights reserved.

Image credit: The Ohio State University Wexner Medical Center.

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Nanochip Could Heal Injuries or Regrow Organs with One Touch - NewsFactor Network

Researchers demonstrate a process known as tissue nanotransfection (TNT). When it comes to healing, this TNT is the bomb.

It's usually bad news to have something growing on your skin, but new technology uses that all important layer as a sort of garden to "grow" whatever types of cells your body might need to treat an injury or disease, be it in a limb or even the brain.

Researchers atthe Ohio State University Wexner Medical Centerhave developed a nanochip that uses a small electrical current to deliver new DNA or RNA into living skin cells, "reprogramming" them and giving them a new function.

"It takes just a fraction of a second. You simply touch the chip to the wounded area, then remove it,"Chandan Sen, director of the Center for Regenerative Medicine and Cell-Based Therapies at Ohio State, said in a statement. "At that point, the cell reprogramming begins."

In a study published in the journal Nature Nanotechnology, Sen's team used a technology called Tissue Nanotransfection (TNT) to create new blood vessels in pigs and mice with badly injured limbs that lacked blood flow.

They zapped the animals' skin with the device, and within about a week, active blood vessels appeared, essentially saving the creatures' legs. The tech was also used to create nerve cells from skin that were then harvested and injected into mice with brain injuries to help them recover.

"By using our novel nanochip technology, injured or compromised organs can be replaced," Sen said. "We have shown that skin is a fertile land where we can grow the elements of any organ that is declining."

While it sounds futuristic, reprogramming skin cells is not a new idea. The ability to change skin into pluripotent stem cells, sometimes called "master" cells, earned a few scientists a Nobel Prize half a decade ago. But the new nanochip approach improves upon that discovery by skipping the conversion from skin to stem cell and instead converting a skin cell into whatever type of cell is desired in a single step.

"Our technology keeps the cells in the body under immune surveillance, so immune suppression is not necessary," Sen says.

By now I think we've all learned that beauty is only skin deep, but it might take a while to learn that the same could go for cures, at least if the system works just as well on people.

Next up, the scientists hope to find out by continuing to test their technology in human trials. The aim is that it could eventually be used to treat all sorts of organ and tissue failure, including diseases like Parkinson's and Alzheimers.

Crowd Control: A crowdsourced science fiction novel written by CNET readers.

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Wild new microchip tech could grow brain cells on your skin - CNET