7/15/2016

Stem Cell Clinics Selling Risky Treatments Explode Across the U.S.



Unproven stem cell therapies have been scorned as “medicine’s Wild West.” Patients have died while undergoing treatment. Yet others have called them “miraculous.” Hundreds of NFL players have sought them out.
A study published today in the journal Cell Stem Cell finds that there are 570 clinics operated by 351 companies selling stem-cell procedures directly to consumers in the U.S., raising concerns that unapproved treatments could cost patients thousands of dollars and threaten their health.
“The big question for me is, how did this happen in the United States?” said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics & School of Public Health, who co-authored the study. “It’s often framed as a story about stem cell tourism, that these businesses don’t exist in the United States, they exist elsewhere around the world in Ukraine, Mexico, China, and India. Our findings clearly show that this is a widespread problem here.”
Stem cells are undifferentiated human cells that can be made to grow into different types of tissue. Scientists hope they can one day be used to treat disease or repair injured tissue. But few therapies have been proved in rigorous trials, and unapproved treatments have been linked to harm. The only stem cell treatments approved by the Food and Drug Administration use cells taken from bone marrow, and even those are restricted to specific transplants.
Researchers worry that the legitimate field of stem cell science, which holds great if early promise for medical advances, could be tainted if the public associates it with complications from unapproved treatments.
“We found a subset of businesses that are marketing just an astonishing number of interventions—neurological diseases, spinal cord injuries, immunological diseases, orthopedic injuries and conditions, and cardiac problems,” Turner said. “When I see businesses like that making claims that they can use stem cell interventions for 20, 30, 40 different diseases, that to me raises some pretty obvious questions.”
The companies the study turned up are all over the country.
The companies the study turned up are all over the country.
 
Source: Leigh Turner and Paul Knoepfler
The FDA has issued draft guidelines for stem cell therapies and is planning a public hearing in September on regulating procedures. The agency is “concerned that the hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful,” said Andrea Fischer, a spokeswoman.
Turner and co-author Paul Knoepfler, an associate professor at the UC Davis School of Medicine who runs a stem cell blog called The Niche, identified the businesses using Internet searches, text mining, and analysis of company websites. They turned up several that were marketing treatments for multiple diseases and injuries and weren't being investigated by regulators. They found hot spots: more than 100 companies or clinics in both Florida and California. Beverly Hills and Los Angeles had 30 clinics between them. Texas came in third, with 71 clinics.
Cassandra Hockenson, public affairs manager for the Medical Board of California, said the board doesn't oversee clinics and that the state’s Department of Public Health was tasked with regulating them. The department said it licenses certain facilities that provide stem cells to health care facilities but doesn't regulate clinics. Representatives of the Florida Board of Medicine and the Texas Medical Board, didn't respond to requests for comment.
More than half the clinics the study examined involve fat-based treatments that work like “mini-liposuctions,” Knoepfler said. Clinics extract fat cells, treat the removed fat with an enzyme to liquefy it, spin it to separate cells from fat, then reinject the cells in various locations to treat injuries and diseases. Of the businesses Knoepfler and Turner identified, 61 percent offered fat-based treatments and 48 percent bone-marrow treatments.
“I was shocked," said Larry Goldstein, director of the UC San Diego Stem Cell Program and a member of the International Society for Stem Cell Research, who wasn't involved in the study. "I knew that the number of problem clinics was growing, but I hadn’t realized it had grown to this extent.” Goldstein said he would have predicted there were about 100 clinics in the U.S. In February, STAT News estimated as many as 200.
The clinics operate in a regulatory gray area. A substance derived from a patient’s own cells isn't considered a drug subject to approval by the FDA. It wasn’t until October 2014 that the FDA issued the first of four sets of draft guidelines to clarify which treatments would be considered drugs and subjected to more scrutiny. The agency has since issued a handful of warning letters or other censures to clinics.

Knoepfler said the clinics might have proliferated in places where people are more accepting of alternative medicine that doesn't require FDA approval, including states such as California. Turner said clinic operators may have noticed state medical boards that aren’t as active in regulating physicians. And existing plastic surgery clinics could repackage their offerings to market stem cell procedures, he said.

“Why is it that some companies are getting these warning letters and other ones, doing similar kinds of things, don’t seem to be attracting the attention of regulators—the FDA, the FTC, state medical boards?” Turner said. He cited limited resources at the FDA, the Federal Trade Commission, and state medical boards that license physicians as a possibility.
The FTC can act against companies engaging in deceptive advertising and has fought the misleading marketing of dietary supplements and clinics making claims about other alternative treatments. It hasn't yet acted on stem cell treatments, said Mitch Katz, a senior public affairs specialist at the agency.
Tim Caulfield, research director of the Health Law Institute at the University of Alberta, helped write guidelines that the International Society for Stem Cell Research published last month urging caution in discussing the promise of stem cell medicine. He said the lack of clear rules on what treatments are prohibited allowed clinics to flourish.
“Regulatory uncertainty," Caulfield said, "created a market opportunity."
(Updates to add comment from California Department of Public Health.)

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Post Polio Litaff, Association A.C _APPLAC Mexico

The Polio Crusade

THE POLIO CRUSADE IN AMERICAN EXPERIENCE A GOOD VIDEO THE STORY OF THE POLIO CRUSADE pays tribute to a time when Americans banded together to conquer a terrible disease. The medical breakthrough saved countless lives and had a pervasive impact on American philanthropy that ... Continue reading..http://www.pbs.org/wgbh/americanexperience/polio/

Erradicación de La poliomielitis

Polio Tricisilla Adaptada

March Of Dimes Polio History

Dr. Bruno

video

movie

movie2

A 41-year-old man developed an acute illness at the age of 9 months during which, following a viral illness with headache, he developed severe weakness and wasting of the limbs of the left side. After several months he began to recover, such that he was able to walk at the age of 2 years and later was able to run, although he was never very good at sports. He had stable function until the age of 18 when he began to notice greater than usual difficulty lifting heavy objects. By the age of 25 he was noticing progressive difficulty walking due to weakness of both legs, and he noticed that the right calf had become larger. The symptoms became more noticeable over the course of the next 10 years and ultimately both upper as well as both lower limbs had become noticeably weaker.

On examination there was wasting of the muscles of upper and lower limbs on the left, and massively hypertrophied gastrocnemius, soleus and tensor fascia late on the right. The calf circumference on the right exceeded that on the left by 10 cm (figure1). The right shoulder girdle, triceps, thenar eminence and small muscles of the hand were wasted and there was winging of both scapulae. The right quadriceps was also wasted. The wasted muscles were also weak but the hypertrophied right ankle plantar flexors had normal power. The tendon reflexes were absent in the lower limbs and present in the upper limbs, although the right triceps was reduced. The remainder of the examination was normal.

Figure 1

The patient's legs, showing massive enlargement of the right calf and wasting on the left

Questions

1
What is that nature of the acute illness in infancy?
2
What is the nature of the subsequent deterioration?
3
What investigations should be performed?
4
What is the differential diagnosis of the cause of the progressive calf hypertrophy?

Answers

QUESTION 1

An acute paralytic illness which follows symptoms of a viral infection with or without signs of meningitis is typical of poliomyelitis. Usually caused by one of the three polio viruses, it may also occur following vaccination and following infections with other enteroviruses.1 Other disorders which would cause a similar syndrome but with upper motor neurone signs would include acute vascular lesions, meningoencephalitis and acute disseminated encephalomyelitis.

QUESTION 2

A progressive functional deterioration many years after paralytic poliomyelitis is well known, although its pathogenesis is not fully understood.2 It is a diagnosis of exclusion; a careful search for alternative causes, for example, orthopaedic deformities such as osteoarthritis or worsening scoliosis, superimposed neurological disorders such as entrapment neuropathies or coincidental muscle disease or neuropathy, and general medical causes such as respiratory complications and endocrinopathies.3

QUESTION 3

Investigations revealed normal blood count and erythrocyte sedimentation rate and normal biochemistry apart from a raised creatine kinase at 330 IU/l (normal range 60–120 IU/l), which is commonly seen in cases of ongoing denervation. Electromyography showed evidence of denervation in the right APB and FDI with polyphasic motor units and complex repetitive discharges, no spontaneous activity in the left calf and large polyphasic units in the right calf consistent with chronic partial denervation. Motor and sensory conduction velocities were normal. A lumbar myelogram was normal. Magnetic resonance imaging (MRI) scan of the calves is shown in figure2.

Figure 2

Axial T1 weighted MRI scan (TR 588 ms, TE 15 ms) of the calves, showing gross muscle atrophy and replacement by adipose tissue on the left, and hypertrophy of the muscles on the right, with only minor adipose tissue deposition

QUESTION 4

The differential diagnosis of the progressive calf hypertrophy is given in the box.

Causes of calf muscle hypertrophy

Chronic partial denervation

  • radiculopathy

  • peripheral neuropathy

  • hereditary motor and sensory neuropathy

  • spinal muscular atrophy

  • following paralytic poliomyelitis

    Neuromyotonia and myokymia

  • Isaac's syndrome

  • generalised myokymia

  • neurotonia

  • continuous muscle fibre activity due to: chronic inflammatory demyelinating polyradiculopathy, Guillain Barre syndrome, myasthenia gravis, thymoma, thyrotoxicosis, thyroiditis

    Muscular dystrophies

    Myositis

    Infiltration

  • tumours

  • amyloidosis

  • cysticercosis

    Link here