Category Archives: Stem Cell Therapy

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.

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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?

Beverly Hills, CA (PRWEB) February 17, 2015

The top stem cell clinic in Los Angeles and Beverly Hills is now achieving 80% success with stem cell therapy for all types of arthritis and soft tissue indications. This includes hip, knee, shoulder, elbow and ankle injections for helping patients achieve pain relief and avoid surgery. Call (310) 438-5343 for more information on the treatment options available and scheduling.

Dr. Raj, who was recently named a Super Doc Southern California for the 4th year in a row, has been performing stem cell therapy on patients for years. This includes athletes, weekend warriors, celebrities, executives, senior citizens and students as well.

There are two methods offered for the treatment, one of which is Bone Marrow derived. This includes harvesting bone marrow from the patient's hip area, and then the material is immediately processed to concentrate the stem cells and growth factors. the fluid is then injected into the problem area. An internal review at Beverly Hills Orthopedic Institute has shown that 80% of patients achieve excellent pain relief and increased functional abilities. This includes getting back to athletics, recreational activities and walking more.

The second method of treatment involves amniotic derived stem cell rich injections. The amniotic fluid is processed at an FDA regulated lab, with no fetal tissue being involved and no embryonic stem cells at all. Amniotic fluid has been used tens of thousands of times worldwide for many indications, and contains growth factors, hyaluronic acid and stem cells.

Indications for the treatment include tennis and golfer's elbow, plantar fasciitis, degenerative arthritis of the hip, knee, shoulder, elbow, ankle, ligament injuries, and tendonitis of the shoulder, knee, achilles and more.

Dr. Raj is a Double Board Certified orthopedic doctor in Los Angeles and serves as an ABC News Medical Correspondent and a WebMD expert. He is called frequently by networks for his opinion on orthopedic matters, and is on the Medical Advisory Board for R3 Stem Cell.

For more information and scheduling with the top stem cell clinic in Los Angeles and Beverly Hills, call (310) 438-5343.

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Dr. Raj at Beverly Hills Orthopedic Institute Achieving 80% Success with Stem Cell Therapy

ALAMEDA, Calif. & JERUSALEM--(BUSINESS WIRE)--BioTime, Inc. (NYSE MKT: BTX) and its subsidiary Cell Cure Neurosciences Ltd. (Cell Cure) today provided an update on Cell Cures product development and partnering activities.

On February 16, 2015, Cell Cure opened the clinical trial of OpRegen titled Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy at Hadassah University Medical Center in Jerusalem, Israel. Patient enrollment is expected to begin shortly. OpRegen consists of animal product-free retinal pigment epithelial (RPE) cells with high purity and potency.

On October 31, 2014, the United States Food and Drug Administration (FDA) cleared Cell Cure's Investigational New Drug (IND) application to initiate the clinical trial of OpRegen in patients with the severe form of age-related macular degeneration (AMD) with geographic atrophy (GA). While treatment options exist for the treatment of the wet form of AMD, it amounts to only about 10% of the disease prevalence. There is currently no FDA-approved therapy for the dry form occurring in approximately 90% of those afflicted with AMD. Cell Cure intends to transplant OpRegen as a single dose into the subretinal space of patients eyes in order to test the safety and efficacy of the product in this leading cause of blindness.

The Phase I/IIa clinical trial, will evaluate three different dose regimens of OpRegen. Following transplantation, the patients will be followed for 12 months at specified intervals, to evaluate the safety and tolerability of the product. Following the initial 12 month period, patients will continue to be monitored at longer intervals for an additional period of time. A secondary objective of the clinical trial will be to examine the ability of transplanted OpRegen to engraft, survive, and moderate disease progression in the patients. In addition to thorough characterization of visual function, a battery of ophthalmic imaging modalities will be used to quantify structural changes and rate of GA expansion.

Cell Cure also announced today that the option granted to Teva Pharmaceutical Industries Ltd. (Teva) under a Research and Exclusive Option Agreement of October 7, 2010 to license-in rights to its OpRegen product has expired without having been exercised by Teva. Cell Cure will therefore be continuing the clinical development of OpRegen on its own and pursuing discussions with other potential strategic partners, including those that have already indicated interest in participating in development and commercialization of the product.

Cell Cure also announced that US patent No. 8,956,866 relating to a proprietary method of manufacturing RPE cells (the active ingredient of OpRegen) is expected to issue on February 17, 2015. This patent combined with other patents and patent applications in the BioTime family of companies provides significant patent protection for this novel therapeutic modality for AMD.

The large markets currently associated with therapies for the wet form of AMD combined with the elegance of RPE replacement therapy for the larger unmet needs associated with the dry form, highlights why Cell Cure has prioritized the development of this product, said Dr. Charles Irving, CEO of Cell Cure. We look forward to initiation of the trials and providing updates in the coming months.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is one of the major diseases of aging and is the leading eye disease responsible for visual impairment of older persons in the US, Europe and Australia. AMD affects the macula, which is the part of the retina responsible for sharp, central vision that is important for facial recognition, reading and driving. There are two forms of AMD. The dry form (dry-AMD) advances slowly and painlessly but may progress to geographic atrophy (GA) in which RPE cells and photoreceptors degenerate and are lost. Once the atrophy involves the fovea (the center of the macula), patients lose their central vision and may develop legal blindness. There are about 1.6 million new cases of dry-AMD in the US annually, and as yet there is no effective treatment for this condition. About 10% of patients with dry-AMD develop wet (or neovascular) AMD, the second main form of this disease, which usually manifests acutely and can lead to severe visual loss in a matter of weeks. Wet-AMD can be treated with currently-marketed VEGF inhibitors. However, such products typically require frequent repeated injections in the eye, and patients often continue to suffer from continued progression of the underlying dry-AMD disease process. Current estimated annual sales of VEGF inhibitors for the treatment of the wet form of AMD are estimated to be in excess of $5 billion worldwide. The root cause of the larger problem of dry-AMD is believed to be the dysfunction of RPE cells. One of the most exciting therapeutic approaches to dry-AMD is the transplantation of healthy, young RPE cells to support and replace the patients old degenerating RPE cells, which may prevent progression of the atrophy as well as the development of wet-AMD. Pluripotent stem cells, such as hESCs, can provide an unlimited source for the derivation of such healthy RPE cells for transplantation.

About OpRegen

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Cell Cure Neurosciences Ltd. Provides Update on its Product Development and Partnering Activities

FAQ Part 3: MEsenchymal Stem cell therapy for CAnadian MS patients (MESCAMS)
The Multiple Sclerosis Society of Canada and the Multiple Sclerosis Scientific Research Foundation have announced a $4.2 million grant in support of the MEse...

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FAQ Part 3: MEsenchymal Stem cell therapy for CAnadian MS patients (MESCAMS) - Video