Stem Cell Clinic

Unproven stem cell ‘therapy’ blinds three patients at Florida clinic – Stanford Medical Center Report

Each patient paid $5,000 for the procedure. Any clinical trial that has a fee should raise a red flag, the authors said.

Im not aware of any legitimate research, at least in ophthalmology, that is patient-funded, Albini said.

At the clinic, which is not named in the paper, the patients had fat cells removed from their abdomens and a standard blood draw. The fat tissue was processed with enzymes, with the goal of obtaining stem cells. Platelet-dense plasma was isolated from the blood. The cells were then mixed with the platelet-dense plasma and injected into their eyes. Patients reported that the entire process took less than an hour, Albini said. The patients had both eyes treated at once another red flag, Albini and Goldberg said, because most doctors would opt for a conservative approach to observe how one eye responds to an experimental treatment before attempting the other eye.

Shoddy stem cell preparation may have led to some of the patients complications, which could have been caused by injection of a contaminant or the cell wash solution into the eye, Albini said. When injected into the eye, the stem cells also could have changed into myofibroblasts, a type of cell associated with scarring.

But even if executed correctly, there is no evidence suggesting that the procedure could help restore vision, Goldberg and Albini said. In fact, there is sparse evidence that adipose-derived stem cells, the type of cells that the clinic claimed to use, are capable of differentiating, or maturing, into retinal pigment epithelium or photoreceptor cells, which play a critical role in macular degeneration and are the cells some researchers are targeting to develop therapies.

There is a lot of very well-founded evidence for the positive potential of stem therapy for many human diseases, but theres no excuse for not designing a trial properly and basing it on preclinical research, Goldberg said.

The trial lacked nearly all of the components of a properly designed clinical trial, including a hypothesis based on laboratory experiments, assignment of a control group and treatment group, collection of data, masking of clinical and patient groups, and plans for follow-up, Goldberg and Albini said. There was a whole list of egregious things, Albini said.

Listings on ClinicalTrials.gov are not fully scrutinized for scientific soundness, Goldberg said. Although still visible on the website, the listing now states: This study has been withdrawn prior to enrollment. The clinic is also no longer performing these eye injections, although it is still seeing patients, Albini said.

The procedures were arguably not subject to Food and Drug Administration approval because the cells were not transferred between patients and were considered minimally processed, according to Title 21, Part 1271.10, of the Code of Federal Regulations. The FDA released more specific guidelines in October 2015, after these procedures were performed, establishing the requirement for FDA oversight and approval for these types of procedures.

We expect health care providers to take every precaution to ensure patient safety, but this definitely shows that the lack of oversight can lead to bad players and bad outcomes. Its alarming, Albini said.

The authors acknowledged that it is difficult for patients to know whether a clinical trial, or a stem cell therapy, is legitimate. Goldberg recommended that patients considering a stem cell treatment consult a website, A Closer Look at Stem Cells, maintained by the International Society for Stem Cell Research. It is also advisable to check if a trial is affiliated with an academic medical center, Goldberg said.

The lead author is Ajay Kuriyan, MD, assistant professor of ophthalmology at the University of Rochester Medical Center. Researchers from the University of Miami, University of Rochester, University of Oklahoma and the Center for Sight also co-authored the study.

The report was funded by the National Institutes of Health (grant P30EY014801), Research to Prevent Blindness, the Department of Defense and the Klorfine Foundation.

Stanfords Department of Ophthalmology also supported the work.

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Unproven stem cell 'therapy' blinds three patients at Florida clinic - Stanford Medical Center Report

Electroacupuncture releases stem cells to relieve pain, promote tissue repair, study finds – Science Daily

A study led by Indiana University School of Medicine researchers demonstrates how electroacupuncture triggers a neurological mechanism that can help promote tissue repair and relieve injury-induced pain.

Their findings, published online March 16 in the journal Stem Cells, provide the most comprehensive picture yet of how electroacupuncture stimulates the brain to facilitate the release of stem cells and adds new insight relating to the cells' healing properties.

Electroacupuncture is a form of acupuncture that uses a small electrical current to augment the ancient Chinese medical practice of inserting fine needles into the skin at pre-determined points throughout the body.

For the study, a team of more than 40 scientists at institutions in the United States and South Korea was led by four senior authors including IU School of Medicine's Maria B. Grant, MD, Marilyn Glick Professor of Ophthalmology and co-corresponding author; Mervin C. Yoder, MD, IU Distinguished Professor, Richard and Pauline Klingler Professor of Pediatrics, associate dean for entrepreneurial research at IU School of Medicine, director of the Herman B Wells Center for Pediatric Research and co-corresponding author; and Fletcher A. White, PhD, Vergil K. Stoelting Chair of Anesthesia, professor of anesthesia, pharmacology and toxicology.

"This work is a classic example of the power of team science, where investigators in different institutions with specific expertise worked together to unravel the complexity of how electroacupuncture works to help the body respond to stressors," said Dr. Yoder.

The researchers performed a series of lab tests involving humans, horses and rodents that follow the effects of electroacupuncture from the stimulus of the needle all the way to the brain, resulting in the release of reparative mesenchymal stem cells (MSCs) into the bloodstream.

Depending on the species, electroacupuncture led to activation of the hypothalamus -- a part of the brain that controls the nervous system and involuntary bodily functions such as heart rate and digestion -- within nine to 22 minutes. The stem cells were mobilized within two hours.

"The acupuncture stimulus we're giving these animals has a rapid effect on neuroanatomical pathways that connect the stimulus point in the arm to responsive neurons in the spinal cord and into a region in the brain called the hypothalamus. In turn, the hypothalamus directs outgoing signals to stem cell niches resulting in their release," said Dr. White, who is a neuroscientist at the Richard L. Roudebush VA Medical Center in Indianapolis.

The researchers found electroacupuncture treatments resulted in higher thresholds for injury-induced pain, as well as considerable increases in the presence of a type of collagen that promotes tendon repair and anti-inflammatory cells known to be predictors of faster healing time.

Dr. White said these findings could lead to new strategies for tissue repair and pain management related to injuries.

"We could potentially capture the MSCs from an individual's blood following electroacupuncture and save the cells for future re-introduction in the patient post-surgery or to treat chronic pain due to an injury," he said.

The horses used in the study had been injured during training for international dressage competitions, and the six people who took part were healthy volunteers, who still showed activation of their hypothalamus through brain imaging.

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Electroacupuncture releases stem cells to relieve pain, promote tissue repair, study finds - Science Daily

Kadimastem Granted a Patent in the US for Treatment of Neurodegenerative Diseases – Yahoo Finance

NESS ZIONA, Israel, March 16, 2017 /PRNewswire/ --

Israeli biotechnology company Kadimastem (KDST.TA), announced that it has been granted a patent from the United States Patent and Trademark Office for its technology in the field of cell based treatment for diseases of the nervous system. The United States patent joins additional patents granted in Israel and Europe.

The patent is for the innovative method of producing supporting cells in the central nervous system from stem cells, including myelin-producing cells, and it is the foundation for the company's products in the field treatment of neurodegenerative diseases.

The technology is the fruit of the research of Professor Michel Revel, the company's Chief Scientist, at the Weizmann Institute. The owner of the patent is Yeda Research and Development Company Ltd. According to an agreement between Kadimastem and Yeda, the company had been granted an exclusive license for exclusive use of the patent.

Kadimastem is developing innovative treatments for a number of severe diseases by transplanting cells and tissues differentiated from human stem cells. The patent expands the intellectual property coverage in the American market as part of the company's strategy in the neurodegenerative diseases field in general and ALS in particular.

Yossi Ben-Yossef, Kadimastem's CEO, noted: "With the company's preparations for the first clinical trial of its unique product, the reinforcement of the company's IP is particularly important. The United States is a target market for the company's products for several reasons, including regulatory (the company will conduct the trial according to the outline coordinated with the FDA), strategic collaborations, potential investors and market size. The patent granted in the United States is a substantial asset in each of these aspects."

Professor Michel Revel, the company's Chief Scientist, added: "The granting of the patent is an international recognition of the uniqueness of the technology at the basis of the cell based treatment for ALS, which Kadimastem develops toward the upcoming clinical trial. The patent also has applications in additional nervous system diseases, and it reinforces the company's position in the field."

About Kadimastem

Kadimastem (http://www.kadimastem.com) is a biotechnology company that specializes in the development of human stem cell-based medical solutions for the treatment of diabetes and neurodegenerative diseases, such as ALS and Multiple Sclerosis. The company was founded in August 2009 by Professor Michel Revel and Yossi Ben Yosef, and is traded on the Tel Aviv Stock Exchange (KDST.TA). The company's chairman is Dr. Eli Opper, formerly the Chief Scientist of the Israeli Ministry of Industry, Labor and Trade. The company's investors, in addition to the founders, include Altshuler Shaham Investment House, foreign investors (Julien Ruggieri and Avi Meizler), and additional institutional investors.

Kadimastem was founded based on patent protected technology that was developed at the Weizmann Institute of Science. Based on the company's unique platform, Kadimastem is developing two types of medical applications: A. Regenerative medicine, which repairs and replaces organs and tissue by using functioning cells differentiated from stem cells. The company focuses on transplanting healthy brain cells to support the survivability of nerve cells as cell therapy for ALS, and transplanting insulin-secreting pancreatic cells for the treatment of insulin-dependent diabetes; B. Drug screening platforms, which use functional human cells and tissues to discover new medicinal drugs. The company has two collaboration agreements with leading global pharmaceutical companies.

Kadimastem has an extensive scientific advisory board, featuring prominent scientists and pioneers: in the embryonic stem cells field, Professor Benjamin Reubinoff, Director of the Hadassah Human Embryonic Stem Cell Research Center and Senior Physician at the Department of Obstetrics and Gynecology at the Hadassah University Medical Center; Professor Joseph Itskovich, world renowned expert and pioneer in pluripotent stem cell research and former head of Obstetrics and Gynecology at RAMBAM Medical Center; in the neurodegenerative disease field, Professor Tamir Ben-Hur, Head of the Department of Obstetrics and Gynecology at Hadassah University Medical Center; and in the diabetes field, Professor Shimon Efrat, professor of Human Molecular Genetics and Juvenile Diabetes at Tel Aviv University and a world renowned expert in cell replacement therapy for diabetes and Professor Eddy Karnieli, former Director of the Institute for Endocrinology, Diabetes and Metabolism at the RAMBAM Medical Center, and a world renowned expert in these fields.

Contact: Kadimastem Yehuda Feinberg +972-73-7971600 y.feinberg@kadimastem.com

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Kadimastem Granted a Patent in the US for Treatment of Neurodegenerative Diseases - Yahoo Finance

Reversing Aging of Intestinal Stem Cells – Technology Networks

Intestinal stem cells rejuvenate daily so bowels will stay healthy and function normally, but a new study in Cell Reports suggests they also age along with people and lose their regenerative capacity.

Reporting their data online March 14, researchers suggest that reactivating the signaling of a key molecule lost in aging intestinal stem cells could restore healthy intestinal function in older people. The study was conducted in mice and human intestinal organoids by scientists at Cincinnati Childrens Hospital Medical Center and the Institute for Molecular Medicine, Stem Cells and Aging at the University of Ulm in Germany.

Researchers say their study is the first to indicate that intestinal stem cells which allow different intestinal cell types to renew themselves age as people do. It also is the first to provide clear evidence that diminished signaling in intestinal stem cells (ISCs) by the Wnt protein which is important to cell proliferation and renewal drives the aging process and loss of ISCs ability to rejuvenate intestinal tissues.

Deterioration of Wnt signaling in aging intestinal stem cells may help explain imbalances in food and nutrient absorption in older people, but our paper also shows that biology allows us to reverse this process by restoring Wnt signaling, said Hartmut Geiger, PhD, senior investigator of the study. Pharmacologic interventions will still need to be designed based on this finding, but we know now where to start.

Geiger is a member of the Division of Experimental Hematology and Cancer Biology at Cincinnati Childrens.

Old vs. Young

In tests that compared the intestines of young mice (2 to 3 months old) with those of aged mice (approaching 2 years old), researchers noticed significant differences in the structural architecture of intestine.

Intestines from older mice showed a reduced number of crypts (mucosal glands), and the structures were longer and wider than in younger animals. Older intestines also had longer villi (absorptive tissues) and an elevated number of cells. But the researchers also noticed there were fewer numbers of actively dividing cells in the intestines of the older mice.

Study authors then looked for different characteristics in the ISCs of young and old mouse intestines. Although they did not observe differences in the numbers of ISCs, they did see a decreased presence of molecular markers that denote ISC function. This led them to conclude that ISC function diminishes in older intestines.

Finding Wnt

To identify genetically driven molecular processes that prompt aging and diminished function in ISCs (and in Paneth and goblet cells they form) the researchers subjected ISCs to RNA sequencing analysis. These tests showed significant reductions in gene expression in the older cells, including the down regulation of molecular pathways involving the genes PPAR, SMAD and Wnt.

Because Wnt plays a particularly prominent role in regulating ISCs, the researchers focused on this pathway. In young and old mice they tested the presence and strength of the Wnt signaling pathway in cells of the mesenchyme which forms connective and skeletal tissues. The mesenchyme has recently been identified in other studies as providing a supportive environment for ISCs to form.

The authors also tested Wnt signaling in different intestinal cells from young and old mice, specifically goblet and Paneth cells that secrete proteins and antimicrobial peptides that are important to sustaining healthy intestines. In both instances they observed a decline in Wnt in intestinal tissues from the older animals.

In testing on lab-generated human and mouse intestinal organoids, the researchers also observed declines in Wnt signaling in older intestines along with altered intestinal structures and indications of diminished function.

Molecular restoration

Researchers concluded their study by testing the restoration of Wnt signaling in intestines by adding Wnt3a (an inducer of Wnt signaling) in aged mouse and human organoid models, which were generated with donated human cells. This rejuvenated the regenerative potential of ISCs in the mouse and human modeling systems. It also boosted the generation of Paneth and goblet cells and prompted an increase in the number of intestinal crypts and other critical structures.

The scientists are following up the current study by trying to define the extent to which therapeutic intervention to rejuvenate ISCs might be beneficial to humans.

Reference:

Nalapareddy, K., Nattamai, K. J., Kumar, R. S., Karns, R., Wikenheiser-Brokamp, K. A., Sampson, L. L., . . . Geiger, H. (2017). Canonical Wnt Signaling Ameliorates Aging of Intestinal Stem Cells. Cell Reports, 18(11), 2608-2621. doi:10.1016/j.celrep.2017.02.056

This article has been republished frommaterialsprovided by Cincinnati Children's Hospital. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Reversing Aging of Intestinal Stem Cells - Technology Networks