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Successful Stem Cells Infusion for Multiple Sclerosis on Canadian Patient - IMH in Pune
One of the Patient Mr Watters Richard Anthony, 42yrs old suffering from Multiple Sclerosis disease,Stem Cells therapy consultant - Dr.Mallik Javeri Dr.Amit...

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Successful Stem Cells Infusion for Multiple Sclerosis on Canadian Patient - IMH in Pune - Video

STEM cell products that have been sourced from animals will not gain approval from the Food and Drug Administration (FDA).

Stem cell-based products of animal origin as well as other products classified as restricted are not allowed to be registered or used, said the FDA via Circular 2013-017 released on Wednesday.

The FDA said the order would include the creation, importation, promotion, marketing, and use of animal stem cells.

The circular comes on the heels of the case filed by Dangerous Drugs Board (DDB) Chairman Antonio Villar against individuals responsible for performing an illegal stem cell procedure on him and his wife which used sheep stem cells.

Earlier, the Philippine Medical Association (PMA) said it was looking into the recent deaths of three politicians, who supposedly traveled to Germany last year to receive animal stem cell treatments.

Aside from animal stem cells, also barred in the country are human embryos for research purposes, human embryonic stem cells and their derivatives, aborted human fetal stem cells and their derivatives, and plant parts labeled as stem cell.

In the same circular, the FDA called on stem cell service providers to start registering their products as required by the Department of Health (DOH).

The DOH earlier required registration of stem cell products in a bid to ensure public access to safe and quality stem cell treatments. (HDT/Sunnex)

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FDA won’t legalize animal stem cells

Newswise INDIANAPOLIS -- Indiana University scientists have transformed mouse embryonic stem cells into key structures of the inner ear. The discovery provides new insights into the sensory organ's developmental process and sets the stage for laboratory models of disease, drug discovery and potential treatments for hearing loss and balance disorders.

A research team led by Eri Hashino, Ph.D., Ruth C. Holton Professor of Otolaryngology at Indiana University School of Medicine, reported that by using a three-dimensional cell culture method, they were able to coax stem cells to develop into inner-ear sensory epithelia -- containing hair cells, supporting cells and neurons -- that detect sound, head movements and gravity. The research was reportedly online Wednesday in the journal Nature.

Previous attempts to "grow" inner-ear hair cells in standard cell culture systems have worked poorly in part because necessary cues to develop hair bundles -- a hallmark of sensory hair cells and a structure critically important for detecting auditory or vestibular signals -- are lacking in the flat cell-culture dish. But, Dr. Hashino said, the team determined that the cells needed to be suspended as aggregates in a specialized culture medium, which provided an environment more like that found in the body during early development.

The team mimicked the early development process with a precisely timed use of several small molecules that prompted the stem cells to differentiate, from one stage to the next, into precursors of the inner ear. But the three-dimensional suspension also provided important mechanical cues, such as the tension from the pull of cells on each other, said Karl R. Koehler, B.A., the paper's first author and a graduate student in the medical neuroscience graduate program at the IU School of Medicine.

"The three-dimensional culture allows the cells to self-organize into complex tissues using mechanical cues that are found during embryonic development," Koehler said.

"We were surprised to see that once stem cells are guided to become inner-ear precursors and placed in 3-D culture, these cells behave as if they knew not only how to become different cell types in the inner ear, but also how to self-organize into a pattern remarkably similar to the native inner ear," Dr. Hashino said. "Our initial goal was to make inner-ear precursors in culture, but when we did testing we found thousands of hair cells in a culture dish."

Electrophysiology testing further proved that those hair cells generated from stem cells were functional, and were the type that sense gravity and motion. Moreover, neurons like those that normally link the inner-ear cells to the brain had also developed in the cell culture and were connected to the hair cells.

Additional research is needed to determine how inner-ear cells involved in auditory sensing might be developed, as well as how these processes can be applied to develop human inner-ear cells, the researchers said.

However, the work opens a door to better understanding of the inner-ear development process as well as creation of models for new drug development or cellular therapy to treat inner-ear disorders, they said.

Additional researchers involved in the work were Andrew M. Mikosz, B.S., Andrei I. Molosh, Ph.D., and Dharmeshkumar Patel, Ph.D., of Indiana University School of Medicine.

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Researchers Create Inner Ear Structures From Stem Cells, Opening Potential for New Treatments

July 10, 2013 Indiana University scientists have transformed mouse embryonic stem cells into key structures of the inner ear. The discovery provides new insights into the sensory organ's developmental process and sets the stage for laboratory models of disease, drug discovery and potential treatments for hearing loss and balance disorders.

A research team led by Eri Hashino, Ph.D., Ruth C. Holton Professor of Otolaryngology at Indiana University School of Medicine, reported that by using a three-dimensional cell culture method, they were able to coax stem cells to develop into inner-ear sensory epithelia -- containing hair cells, supporting cells and neurons -- that detect sound, head movements and gravity. The research was reportedly online Wednesday in the journal Nature.

Previous attempts to "grow" inner-ear hair cells in standard cell culture systems have worked poorly in part because necessary cues to develop hair bundles -- a hallmark of sensory hair cells and a structure critically important for detecting auditory or vestibular signals -- are lacking in the flat cell-culture dish. But, Dr. Hashino said, the team determined that the cells needed to be suspended as aggregates in a specialized culture medium, which provided an environment more like that found in the body during early development.

The team mimicked the early development process with a precisely timed use of several small molecules that prompted the stem cells to differentiate, from one stage to the next, into precursors of the inner ear. But the three-dimensional suspension also provided important mechanical cues, such as the tension from the pull of cells on each other, said Karl R. Koehler, B.A., the paper's first author and a graduate student in the medical neuroscience graduate program at the IU School of Medicine.

"The three-dimensional culture allows the cells to self-organize into complex tissues using mechanical cues that are found during embryonic development," Koehler said.

"We were surprised to see that once stem cells are guided to become inner-ear precursors and placed in 3-D culture, these cells behave as if they knew not only how to become different cell types in the inner ear, but also how to self-organize into a pattern remarkably similar to the native inner ear," Dr. Hashino said. "Our initial goal was to make inner-ear precursors in culture, but when we did testing we found thousands of hair cells in a culture dish."

Electrophysiology testing further proved that those hair cells generated from stem cells were functional, and were the type that sense gravity and motion. Moreover, neurons like those that normally link the inner-ear cells to the brain had also developed in the cell culture and were connected to the hair cells.

Additional research is needed to determine how inner-ear cells involved in auditory sensing might be developed, as well as how these processes can be applied to develop human inner-ear cells, the researchers said.

However, the work opens a door to better understanding of the inner-ear development process as well as creation of models for new drug development or cellular therapy to treat inner-ear disorders, they said. Additional researchers involved in the work were Andrew M. Mikosz, B.S., Andrei I. Molosh, Ph.D., and Dharmeshkumar Patel, Ph.D., of Indiana University School of Medicine.

Support for the research was provided by National Institutes of Health grants RC1DC010706, R01GM086544 and R01MH52619, a Paul and Carole Stark Neurosciences Fellowship and an Indiana Clinical and Translational Sciences Institute Predoctoral Fellowship (NIH TL1RR025759).

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Researchers create inner ear from stem cells, opening potential for new treatments

MANILA, Philippines - Stem cells taken from animals and plant derivatives are not allowed in the country, according to a circular of the Food and Drug Administration (FDA).

In FDA Circular 2013-017, FDA acting director Kenneth Hartigan-Go said stem cells harvested from human embryos for research purposes, human embryonic stem cells and their derivatives as well as aborted human fetal stem cells and their derivatives are also not authorized.

Go said such stem cells are prohibited from creation, importation, promotion, marketing and use.

This means that selling and manufacturing of soap and other products that supposedly contain stem cells from placenta and animals, which have been flooding the market recently, are also prohibited.

The FDA circular said imported human stem cell-based products are allowed, provided they are not hand-carried and meet other requirements.

The FDA requires the use of appropriate mode of transportation and storage in transporting allogeneic stem cells or those derived from other humans and not the patient himself.

Under the guidelines previously issued by the Department of Health (DOH), only autologous stem cells, or those taken from the patients themselves, are acceptable.

In Circular 2013-012 issued last May 15, the FDA had also warned the public against receiving unapproved stem cell preparations in non-health facilities.

The agency said unapproved stem cell preparations and therapy without prior FDA-DOH approval could cause infectious diseases and severe complications which may lead to permanent disabilities, physical deformities, autoimmune diseases and even death, without the benefit of health insurance coverage.

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FDA bans stem cells from animals, plants