Category Archives: Stem Cell Therapy

Researchers and physicians are increasingly acknowledging the positive role stem cell therapy plays in managing a host of complicated ailments that were once very difficult to handle.

Among such health conditions is autism, the neuro-developmental disorder that impacts the brain of children and severely hinders development of communication and social interaction skills.

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There is a positive impact of stem cell therapy and conventional rehabilitation for autistic children. Over a period of time, hyperactivity among children is reduced, they are calmer and their eye contact has improved. Attention span and the ability to sit at one place have improved. This allows rehabilitation specialists to work more efficiently with children, claims Nandini Gokulchandran of Neurogen Brain and Spine Institute, Mumbai.

For the past four years, the researcher has been working with 250 children from across the world on stem-cell therapy and autism.

In fact, results from a study of stem cells impact on 32 autistic children by researchers led by Alok Sharma and Dr. Gokulchandran were published in the journal Stem Cells International .

Correcting

the imbalance

Dr. Gokulchandran, who was in the city recently to deliver a talk on autism organised by Durgabai Deshmukh Vocational Training and Rehabilitation Centre, says that through stem cells, vital organs inside the brain are targeted for rejuvenation.

It is widely known that inside the brain, three vital parts cerebellum, hippocampus and amygdala function lesser among autistic children. Other parts in the brain are hyperactive, creating an imbalance.

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Stem cell therapy inches towards an autism cure

About 10 percent of patients with chronic lymphocytic leukemia (CLL) discontinued therapy with the Bruton tyrosine kinase (BTK) inhibitor drug ibrutinib because of disease progression during clinical trials, according to a study published online in JAMA Oncology.

CLL is the most prevalent leukemia in adults and it is not considered curable without an allogeneic (donor) stem cell transplant. However, advances in therapy have been made, notably the emergence of kinase inhibitors for patients whose disease relapsed, according to the study background.

The drug ibrutinib (marketed as Imbruvica) is the first drug designed to target Bruton's tyrosine kinase (BTK), a protein essential for CLL-cell survival and proliferation. The drug is approved by U.S. Food and Drug Administration in chronic lymphocytic leukemia and mantle cell lymphoma. Much of the clinical and basic-science research that led to the approval of ibrutinib for CLL was performed by scientists at The Ohio State University Comprehensive Cancer Center -- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC -- James).

Hematologists Kami Maddocks, MD, Jennifer Woyach, MD, and colleagues have now described the characteristics of patients who discontinued ibrutinib therapy and their outcomes in a group of 308 patients participating in four trials at The OSUCCC -- James.

The study results show that with a median (midpoint) follow-up of 20 months, 232 patients (75 percent) remained on therapy, 31 (10 percent) discontinued because of disease progression and 45 discontinued for other reasons (including 28 because of infection, eight for other adverse events and nine due to other medical events).

Disease progression included Richter's transformation (when the cancer becomes an aggressive lymphoma) or progressive CLL. Richter's transformation appeared to occur early and CLL progression later. Median survival after Richter's transformation was 3.5 months and 17.6 months following CLL progression, the results indicate.

"These data enhance our understanding of how patients do on ibrutinib long-term and who is likely to relapse. We know that many patients will have very durable remissions with ibrutinib, and understanding which patients are at higher risk helps us select who might benefit from clinical trials investigating other new agents and combination therapies rather than starting ibrutinib treatment by itself," says Woyach, senior author of the study. "We have confirmed that specific gene mutations are seen in patients who relapse, which gives us an idea of other drugs that might be effective in these circumstances."

OSUCCC -- James researchers conclude that this data confirms ibrutinib as an effective therapy and identifies, for the first time, baseline factors associated with ibrutinib therapy discontinuation.

"Outcomes data show poor prognosis after discontinuation, especially for those patients with Richter's transformation. Patients with either progressive CLL or Richter's tend to require therapy quickly after ibrutinib is stopped, so having a plan in place for alternative therapy is necessary. This sub-segment of patients who relapse on ibrutinib remains a high research priority to identify new targets and new therapies, and we have multiple studies ongoing at the James to try to help these patients," adds Maddocks.

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Reasons for ibrutinib therapy discontinuation in CLL

Bengaluru:Feb 27, 2015, DHNS

Two courses of stem cell therapy have helped Ashok Kumar, 59, who suffered from tremors and rigidity due to Parkinsons disease, recover completely, much to the joy of his family. The man was brought inside my cabin in a wheelchair. He was unable to even sit on the chair without support. Today, he walks independently. Stem cell therapy has made it possible for him, said Dr Naseem Sadiq, Director, Plexus Neuro and Stem Cell Research Centre, who began treating Kumar in October, last year.

Previously, medication and surgical procedure were the only treatment option for Parkinsons disease. Medication in the long-term often lacks effectiveness and may cause side effects, while surgery is not always feasible. Lately, stem cell therapy has turned out to be a boon for patients with Parkinsons, Dr Sadiq said.

Kumar is among the few who have benefited from stem cell therapy. However, though the State has been reporting an increase in the number of registered stem cell donors, it is far behind sufficient as the genetic match between donor and recipient could be anywhere between one in 10,000 and one in two million, according to experts.

Speaking to Deccan Herald, Raghu Rajgopal, co-founder, Datri, a registry for stem cell donation, said, The response we get from Karnataka when we conduct stem cell camps is great. We see a lot of people and registering with us.

As many as 6,000 people have registered from the State under the Datri registry. A total of 72,000 people have registered across the country. In Kerala, 11,000 have signed up, the highest so far, he said.

Among the common myths are that by donating stem cells one turns infertile and weak, have increased chances of cancer and also that there would be excess loss of blood, he said.

According to studies, over one lakh people are diagnosed with Leukemia (blood cancer) and other blood disorders every year in India. The Indian Council of Medical Research has predicted that by the end of 2015, Leukemia cases will reach an estimated 1,17,649 and 1,32,574 by 2020. Stem cell therapy is a widely used treatment mechanism for Leukemia.

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Stem cell therapy a boon to Parkinson's patients

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Newswise STRATFORD Paola Leone, PhD, the director of the Cell and Gene Therapy Center and a professor of Cell Biology at the Rowan University School of Osteopathic Medicine (RowanSOM), has been awarded a three-year, $477,000 grant from the National Institute of Neurological Disorders and Stroke (NINDS) to develop a stem cell-based therapy for Canavan disease, a rare but devastating neurological disorder in children that typically takes a childs life by age 10.

Canavan disease is a fatal, inherited disease caused by a mutation in the aspartaocylase gene, Dr. Leone explained. The disease is characterized by progressive and severe brain atrophy that manifests in delayed development, developmental regression, microcephaly, spasticity, seizures, visual impairment and short life expectancy. There, currently, is no treatment or cure for Canavan disease.

Under Dr. Leones direction, a team of RowanSOM researchers and students will examine the potential of stem cells for the treatment of Canavan disease in an animal model. This new study will build on the research teams preliminary data that demonstrated the successful engraftment of stem cells in animal models.

Our project will generate pre-clinical data to support the development of a stem-cell based therapy for Canavan disease, Dr. Leone said. It will also provide an important opportunity for a new generation of clinical researchers. Both undergraduate and graduate students will participate in this project, providing them with valuable experience to work with an extremely promising therapeutic intervention.

The symptoms of Canavan disease usually appear within the first six months of a childs life. The disease is caused by a genetic mutation that stops cells, called oligodendrocytes, from developing myelin, the fatty substance that coats the nerves in the brain. Without the protective myelin covering, the nerves do not form properly, causing the brain to atrophy. The preliminary research that Dr. Leone conducted showed that the engraftment of stem cells promoted significant recovery of the myelin sheath surrounding the nerves.

Our research represents a significant departure from other studies that have focused solely on strategies to augment the loss of the aspartaocylase function that is highly reduced in the brains of these patients, Dr. Leone said. We believe that any strategy seeking to treat Canavan must include a way to restore the myelin development that is disrupted in children with this disease.

This research is supported by the NINDS of the National Institutes of Health, under grant number 1R15NS088763-01A1.

Journalists wishing to speak with Dr. Leone, should contact Jerry Carey, Rowan University Media and Public Relations at 856-566-6171 or at careyge@rowan.edu.

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Rowan Researcher Targets Stem Cell-Based Therapy for Rare Childhood Disease

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Newswise LA JOLLA, CA February 25, 2015 A new study led by researchers at The Scripps Research Institute (TSRI) and the University of California (UC), San Diego School of Medicine shows that certain stem cell culture methods are associated with increased DNA mutations. The study points researchers toward safer and more robust methods of growing stem cells to treat disease and injury.

This is about quality control; were making sure these cells are safe and effective, said Jeanne Loring, a professor of developmental neurobiology at TSRI and senior author of the study with Louise Laurent, assistant professor at UC San Diego.

Laurent added, The processes used to maintain and expand stem cell cultures for cell replacement therapies needs to be improved, and the resulting cells carefully tested before use.

The findings were published February 25 in the open-access journal PLOS ONE.

Growing Stem Cells

Because these human stem cells, called "pluripotent stem cells," can differentiate into many types of cells, they could be key to reversing degenerative diseases, such as Parkinsons disease, or repairing injured tissue, such as cardiac muscle after a heart attack. Stem cells are relatively rare in the body, however, so researchers must culture them in dishes.

While all cells run the risk of mutating when they divide, previous research from Loring and her colleagues suggested that stem cell culturing may select for mutations that favor faster cell growth and are sometimes associated with tumors.

Most changes will not compromise the safety of the cells for therapy, but we need to monitor the cultures so that we know what sorts of changes take place, said the papers first author Ibon Garitaonandia, a postdoctoral researcher working in Lorings lab at the time of the study.

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New Study Shows Safer Methods for Stem Cell Culturing

Jeanne Loring holds a petri dish with induced pluripotent stem cells from a Parkinsons patient.

A nine-year legal challenge to human embryonic stem cell patents ended Tuesday, when the Supreme Court declined to hear the case.

The decision means the Wisconsin Alumni Research Foundation, or WARF, will get to keep its patent rights for the cells, which were discovered in 1998 by University of Wisconsin - Madison scientist James Thompson.

However, the challengers succeeded in preventing WARF from gaining rights over another important type of stem cells called induced pluripotent stem cells, said Jeanne Loring, a stem cell scientist at The Scripps Research Institute in La Jolla who was part of a coalition contesting the WARF patents.

IPS cells act much like human embryonic stem cells, and are being researched as an alternative for stem cell therapy. Loring is working with a group that seeks to use them to treat Parkinson's disease.

WARF maintains it has the right to license use of human embryonic stem cells, because Thompson developed the methods to isolate them from embryos, which had not been previously done. Loring said the derivation is an obvious extension of methods used to derive non-primate embryonic stem cells, and therefore not patentable.

Loring and two public interest groups, Consumer Watchdog and the Public Patent Foundation, challenged the patents in 2006, and in 2007 succeeded in narrowing WARF's claims to exclude the IPS cells. Loring and the groups continued the challenge on the grounds that as a product of nature, human embryonic stem cells are not patentable.

The U.S. Patent and Trade Office turned down that challenge, and the case reached the Supreme Court last year. By not hearing the case, the Supreme Court let that decision stand.

"They still own human embryonic stem cells," Loring said. "But the way their patents were originally written, they would have also been able to own IPS cells. If there's one success that I would point to, that was worth all the effort, it's that they can't. And the reason they can't is because we challenged the patent."

Calls and an email sent Tuesday to WARF headquarters in Madison, Wis., were not immediately returned.

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Supreme Court rejects stem cell patent case

PARMA and MODENA, Italy, February 23, 2015 /PRNewswire/ --

The collaborationbetween a public excellent researchcenteranda solidprivate pharmaceuticalcompany allowed toachievean extraordinary result, entirely "made in Italy":the first medicinal productcontainingstem cellsapproved in the Western world

The European Commission has granted a conditional marketing authorization, under Regulation (EC) No 726/2004, to Holoclar, an advanced therapy based on autologous stem cells and capable to restore the eyesight of patients with severe cornea damage. Holoclar is manufactured by Holostem Terapie Avanzate (HolostemAdvanced Therapies) - a spin-off of the University of Modena and Reggio Emilia - at the Centre for Regenerative Medicine "Stefano Ferrari" (CMR) of the same University.

(Logo: http://photos.prnewswire.com/prnh/20150223/731609-a )

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"Holoclaris theveryfirstmedicinalproductbased onstem cellsto beapproved andformallyregisteredin the Western world," states AndreaChiesi, Director of R&D Portfolio Management of Chiesi Farmaceutici S.p.A. and CEO of Holostem Terapie Avanzate. "This record," continues AndreaChiesi,"shows that thepartnershipbetween the public and privatesectorsis not only possible,butisprobably the best strategy for the development of stem cell-based regenerative medicine, particularly when autologous cells are used.Holostemisnowconsideredasabusiness modeltotranslate into clinicstheresultsobtained byscientific researchin this field." Underlying Holoclar are more than 20 years of excellence in research, conducted by a team of internationally renowned scientists in the field of epithelial stem cell biology aimed at clinical translation. European Directive 1394/2007 substantially equalizes advanced cell therapies to medicines and imposes, among other things, that cell cultures has to be manufactured only in GMP-certified facilities (GMP: Good Manufacturing Practice). Thanks to the investments of Chiesi Farmaceutici, the Centre for Regenerative Medicine in Modena - where Holostem operates - was certified as GMP compliant and continue to follow the path towards the registration of this newly developed advanced therapy.

"The authorization processhas been long andcomplex, butthe resultachievedtodayshows thatcellscan beculturedaccording topharmaceutical standardsappropriateto guaranteesafety and efficacy," adds Professor MicheleDeLuca, Scientific Director and co-founder of Holostem, as well as Director of the CMR of the University of Modena. "In addition,ina periodof great confusionabout the realtherapeutic possibilitiesof stem cells,such as the onewe are living in, being ableto demonstratethatstem cells can be definitely safe and successful in a controlled clinical settingismore important than ever." To explain how Holoclar works is Professor GraziellaPellegrini, Coordinator of cell therapy at CMR, as well as director of R&D and co-founder of Holostem, who authored, together with Professor De Luca, the research and designed the product development: "Afterdevelopingcell culturesbased onepithelial stem cellsfor the treatmentofvariousdisorders ofthestratifiedepithelia-from the skinfor full-thicknessburnsto the reconstructionof the urethra-wediscoveredthatthe stem cellsthat allowthe regenerationof the cornearesidein asmall areaatthe borderbetween the cornea(the transparent partat thecenter of the eye)andthe conjunctiva(the contiguous white part),which is called'the limbus'.Whenthermal or chemicalburnsof theocular surfacedamageirreversiblythisstemcellreserve,thecorneal surface-whichin ahealthy eyecompletely renews itself approximatelyeverysix/ninemonths-stopsregeneratingand the conjunctivagraduallybegins tocover thecorneawithawhite coating,thatprevents visionand causes chronicpainandinflammation.Ifinat leastone of the eyes of the patientevenasmallresidueofundamaged limbus is left,we areable to reconstructin a laboratorythe epitheliumthat covers thecorneal surface,thanks to thestem cells harvestedthrough a 1-2mmbiopsy.Thisgraftofepithelium-Holoclar, precisely-that looks likea kind ofcontactlens,is thentransplantedinto the patientandallows to obtain along-termtransparent corneaanda full recoveryof visual acuity,without causing anyrejection reaction,because itconsists of cellsof the patient him/herself."

This therapy, experimentally applied for the first time in humans in the nineties, and designated as orphan drug in 2008, thanks to the registration obtained today, in the near future will be available to all European patients who have suffered workplace injuries (caused, for example, by burnt lime, solvents or acids), domestic accidents (for example eye burns caused in adults and children by detergents or abrasive agents) or - as unfortunately reported by the press in the past few months - in the cases of assault with chemical agents.

Meanwhile, the research in Modena does not stop. The next goal of the team of Emilian researchers and entrepreneurs is to develop new advanced therapy products, such as the gene therapy for the treatment of epidermolysis bullosa, or "Butterfly disease", to date used successfully in the first two patients ever. And to develop new experimental and clinical protocols using different stem cells of stratified epithelia, such as conjunctiva, urethra, oral mucosa and respiratory epithelia.

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Europe Approves Holoclar, the First Stem Cell-Based Medicinal Product

The Facebook post late Thursday night landed like a punch to the gut to everyone who knows Jeff Dienhart.

The beloved Central Catholic girls assistant basketball coach, who has been waging a fierce struggle against the suffocating ravages of cystic fibrosis, abruptly announced that the end is now near.

"I was sent home today from the hospital on hospice care. I received the sacrament of confession and the anointing of the sick last night from father Daniel garland. I am at home under medication. Could have days could have weeks could have months no one knows. Just know I am at peace. I am scared and dont want to leave this place on earth.. I have fought so hard for so long. I am so tired and have suffered so much this year .please pray for my wife Valerie my daughter Alicia and my son drew during this tough time."

My husband and I came to the conclusion that he is a fighter. Odds don't mean anything to him.

It was not supposed to end this way. Dienhart was, in fact, just days away from an experimental stem cell treatment that he hoped would extend his life. Friends, family and the community had raised more than $70,000 to cover the costs.

And Dienhart, 44, had beaten so many odds before.

The statistics suggest, for example, that many men with cystic fibrosis are infertile, yet Dienhart fathered two children.

Central Catholic assistant girls basketball coaches Jeff Dienhart, foreground, and Dave Crandall watch the action as the Knights host Guerin Catholic on Jan. 30. It was the first game for Dienhart in quite a while, as he had spent the better part of the month of January in the hospital. Dienhart is set to receive stem cell treatment in the Dominican Republic to hopefully assist in his battle with cystic fibrosis. (Photo: John Terhune/Journal & Courier)

Nor were CF sufferers supposed to be able to play marathon rounds of golf.

"I would tell the doctor he played 36 holes of golf in 90-degree heat," said Dienhart's mother, Kathy Dienhart. "The doctor would tell me I made that up. My husband and I came to the conclusion that he is a fighter. Odds don't mean anything to him."

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Can stem cell therapy save a beloved coach?