Category Archives: Cell Therapy

VetStem constructed and validated a state-of-the-art GMP stem cell manufacturing plant at its headquarters laboratory in Poway, California

Poway,CA (PRWEB)- VetStem Biopharma, Inc., announced the opening of its GMP cell therapy manufacturing facility at its headquarters laboratory in Poway, California. Based upon 12 years of knowledge gained by following GTP laboratory guidelines and utilizing the experience of both in-house personnel and consultants, VetStem constructed and validated a state-of-the-art GMP stem cell manufacturing plant. This clean room facility has already produced three registration batches of stem cell product and those batches have been officially released for use in pivotal FDA studies of safety and efficacy.

Carolyn Wrightson, Ph.D., VP of Operations, stated, This facility is the culmination of six years of planning and research, supported by over 12 years of commercial stem cell laboratory operations by VetStems experienced cell therapy team. We believe this is the first dedicated veterinary-specific cell therapy facility in the United States. It will provide all the stem cell products for use in VetStem FDA product development programs. The facility operates under FDA GMP guidelines and is designed to produce commercial products, once approved by the FDA.

Quality is a critical element necessary to bring stem cell therapy into mainstream veterinary practice. VetStem has been committed to quality since its founding and has worked directly with the FDA Center for Veterinary Medicine since 2003 to assure our products and services adhere to the strictest guidelines for safety and efficacy, saidBob Harman, DVM, MPVM, CEOof VetStem. VetStem offers tours of this unique facility via large viewing windows in an exterior corridor and veterinarians are amazed at the high tech approach to veterinary cell therapy including the specialized approach to donor selection, disease screening, clean room cell culture and final packaging of the product in specialized cell product vials.

Stem cell therapy is a truly novel and natural approach to treatment of acute and chronic diseases in animals that have few or less efficacious therapeutic options. Using donor derived allogeneic stem cells provides cell therapy in a ready to use format without the need for tissue collection, or processing thus expanding the availability to more animals. VetStem is dedicated to providing affordable stem cell therapy for diseases of dogs, cats and horses, especially in areas of unmet needs, according to Harman.

About VetStem Biopharma VetStem Biopharma is a veterinarian-lead company that was formed in 2002 to bring regenerative medicine to the profession. This privately held biopharmaceutical enterprise, based near San Diego (California), currently offers veterinarians an autologous stem cell processing service (from patients own fat tissue) among other regenerative modalities. With a unique expertise acquired over the past 14 years and 12,000 patients treated by veterinarians for joint, tendon or ligament issues, VetStem has made regenerative medicine applications a therapeutic reality beyond the realm of research. The VetStem team is focused on developing new clinically practical and affordable veterinary solutions that leverage the natural restorative abilities present in all living creatures. The companys stated mission is to extend and enhance the lives of animals by improving the quality of recovery in acute conditions, but also by unlocking ways to slow, stop and ultimately revert the course of chronic diseases. In addition to its own portfolio of patents, VetStem holds exclusive global veterinary licenses to a portfolio of over 70 issued patents in the field of regenerative medicine.

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VetStem Biopharma, Inc., Announces The Opening Of Its GMP Cell Therapy Manufacturing Facility - Laboratory Network

Humans have about 15,000 inner ear-hair cells, each one picking up sound vibrations, converting them to electric signals and sending them to the brain for processing.

Over time, loud noise, medications and old age combine to kill these cells and their microscopic hairs called stereocilia which leads to hearing loss. Unlike other animals, however, humans and mammals can't regrow them. But a group of scientists based in Boston say they've figured out a way to switch on the body's cellular factories and possibly reverse hearing loss.

"The biology is there, we just need to awaken it," said Jeffrey Karp, associate professor at Brigham and Women's Hospital, Harvard Medical School and an author on the new study appearing Tuesday in the journal Cell Reports. "For some reason there are brakes that we need to release for a short period of time to allow new hair cells to be produced."

RELATED: Can We Reverse Hearing Damage?

Karp and colleagues were able to regrow the hair cells by activating a stem cell in the cochlea called Lgr5 with a small molecule drug treatment. A similar stem cell is found in the human intestine and allows the body to regrow the exterior lining of the organ every five days.

The team also obtained a human cochlea from a patient who suffered from cancer and were able to regrow hair cells with their drug treatment.

"We don't want to provide false hope, but we are highly encouraged by this work. And our ability to produce bona fide functional hair cells is very compelling," Karp said.

The next step is taking the experimental data and starting a human clinical trial. Karp and Robert Langer of MIT are co-founders in a small startup firm, Frequency Therapeutics, that's working toward a phase I trial in the next 18 months, according to Karp.

A possible drug treatment for hearing loss could help the 360 million people worldwide who suffer from the condition.

RELATED: Why Does Loud Music Cause Hearing Loss?

"Their proposal is very novel and essentially by activating these supporting cells, a natural process will take over and a certain percentage would become hair cells capable of playing a role in the encoding of sound," said Nicolas Reed, an instructor in otolaryngology at the Johns Hopkins School of Medicine. "I don't see any obvious negative indications right now."

Hearing loss can lead to big problems as we age, including the onset of Alzheimer's disease, falls and social isolation, according to Larry Medwetsky, chairman of our Department of Hearing, Speech and Language Sciences at Gallaudet University.

"It is not a minor matter," Medwetsky said. "Hearing loss can affect you mentally and emotionally. If you can prevent or remediate it than you can also you can restore quality of life and avoid some of these issues."

WATCH: How Did Human Hearing Evolve?

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Stem Cell Therapy Could Reverse Hearing Loss - Seeker

Osteoarthritis is the most common form of arthritis in the US, affecting nearly twenty-seven million adults. It is currently an incurable disease in which the joints deteriorate. Now, a therapy that has been used in eye surgery and to heal the skin of burn victims is being used for the first time in knees and this new form of treatment involves stem cells from amniotic fluid.

As a professional photographer, climbing up step ladders and walking down stairs are part of the daily grind for 65-year-old Linda Schwartz.

"Theres constant activity; youre moving the whole time, really," said Schwartz.

But the pain of osteoarthritis in both of her knees was making all that activity a little harder.

"Tried cortisone shots. I had, um, something called Euflexxa. I was sent to physical therapy twice. I mean, I did try acupuncture in my knees. But it didnt really seem to make a difference," said Schwartz.

"Its like the rubber on the tire. So as you start to lose the rubber in your tire and the rim hits the road, thats what happens when you have bone on bone arthritis and youve lost all the cartilage in your knee," said dr. Adam Yanke, an orthopedic surgeon at rush university medical center.

Orthopedic surgeon Adam Yanke enrolled Schwartz in an experimental new therapy that involved injecting amniotic fluid that contained stem cells donated by healthy mothers into the knees of osteoarthritis patients.

"Between the two of those theyre a potent anti-inflammatory and they also have growth factors that help promote healing or healthy growth of tissue," said Dr. Yanke.

It was by far the most effective pain treatment that Schwartz has tried and, unlike cortisone shots, there are no side effects. The pain relief has so far lasted up to a year.

"It was a very gradual feeling of its a little bit better, its a little bit better, and then realizing, wow, its really pretty good," said Schwartz.

The one drawback is this therapy is not for patients whose arthritis is so bad it requires knee replacement surgery. Even though its still in the experimental stage, Dr. Yanke offers the stem cell treatment to his patients, but at a cost of 2200 dollars a shot, it is not yet covered by insurance.

TOPIC: Heart Attack: Slashing Door-To-Balloon Times REPORT: MB #4218

BACKGROUND: A heart attack is an event that occurs when the blood flow that transmits oxygen to the heart is severely reduced or stopped completely. One reason for this blood flow to become reduced is because of the blockage of an artery due to fat, cholesterol or plaque. About every 43 seconds, a person in America suffers from a heart attack. The most common symptoms of a heart attack are the following: * Chest discomfort, including uncomfortable pressure, squeezing or pain in the chest that lasts more than a few minutes, or that goes away and later comes back. * Discomfort in other areas of the body, including pain in the arms, back, neck, jaw or stomach. * Shortness of breath. * Cold sweat, nausea and lightheadedness The most common symptom in men is chest pain, whereas women are more likely to experience shortness of breath, vomiting and pain in other parts of the body.

(Source: http://www.heart.org/HEARTORG/Conditions/HeartAttack/AboutHeartAttacks/About-Heart-Attacks_UCM_002038_Article.jsp)

ACTING FAST: Heart attacks are very delicate events, and in order to overcome them it is important to act fast. If you think you are suffering from a heart attack it is important to call 911 immediately in order to be treated as soon as possible in a hospital with treatments like balloon angioplasty, clot-dissolving drugs, surgery and/or a combination of all of the above.

(Source: http://www.heart.org/HEARTORG/Conditions/HeartAttack/TreatmentofaHeartAttack/Treatment-of-a-Heart-Attack_UCM_002042_Article.jsp)

DOOR-TO-BALLOON: In order to save lives it is not only important that the patient acts fast, but the hospital does as well; every minute matters. Normally, severe heart attacks like a STEMI are treated with a door-to-balloon protocol. Door-to-balloon is the time that elapses from when a patient enters the door of the hospital to the time blood flow is circulating to heart again. The American College of Cardiology suggests that this time should be 90 minutes or less. In order for these times to be achieved it is important that everyone involved is working consistently and together; this includes doctors, nurses, paramedics, and pharmacists. There is a checklist these professionals have to follow and the data of each patient is posted daily. The Cleveland Clinic has been able to cut the door-to-balloon time almost in half. Thirty-five percent of their patients have had door-to-balloon times of 45 minutes or less and others were able to be treated in only 21 minutes. Researchers will soon publish the results of how their protocol reduces the overall time and how it is specifically impacting death rates.

(Source: Dr. Travis Gullet & https://consultqd.clevelandclinic.org/2016/05/streamlined-stemi-protocol-slashes-door-balloon-times/)

FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT: Andrea Pacetti pacetta@ccf.org

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Stem cell therapy being used for osteoarthritis - WNDU 16 - WNDU-TV

Opinion: Oregon patients should beware of stem cell therapy fraud Portland Business Journal Patients in Oregon seeking accurate information about stem cell therapy have few reliable sources to guide them. It can be hard to separate scientific facts from science fiction. Query Dr. Google and you'll find a slew of clinics and a broad range of ...

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Opinion: Oregon patients should beware of stem cell therapy fraud - Portland Business Journal

COLUMBUS For the past year, Dr. Todd Paczosa has been practicing what he calls the future of medicine.

The veterinarian treats his four-legged patients through stem cell therapy.

Im not anti-antibiotic, anti-medicine. I just believe that even in the future of cancer treatment that it is going to come down to your body healing itself, Paczosa said.

The process involves removing fatty tissue from a patient, extracting stem cells, then injecting the cells back into the animal's joints to promote healing.

Paczosa said he researched the treatment for about a decade before deciding to offer it at Redstone Veterinary Hospital in Columbus.

Our body is full of cells that heal. You get cut, your body heals. What we are doing is taking those cells, waking them up and saying, Hey, lets go to work, he said.

Since he started offering stem cell therapy last March, 17 dogs, horses and cattle have used the treatment. One of those patients is Butch, a 9-year-old schnauzer owned by Marge Biester of Columbus that was suffering from a strained ligament and achy joints.

He was really hurting. I had to do something for him, Biester said, adding that Butch wasnt putting much weight on his back leg when he walked.

The treatment was done in January. Butch was put under anesthesia to retrieve the fat tissue. Using equipment in-house, the stem cells were extracted and injected back into the dog that same day.

Paczosa, who has been a veterinarian for 23 years, said the entire process can be done in a day.

Biester noticed results in about two weeks.Butch wasnt doing his three-legged walk anymore and began acting like a more-active, younger version of himself.

Im amazed at how quickly he recovered, she said.

Paczosa said all of the animals he has treated so far have shown improvement.

One of these days, we will have one that doesnt work. Thats just medicine, but we havent had one yet, he said.

The possibility of the stem cell therapy not working can be a turnoff for some pet owners who might find it difficult to spend $1,900 to $2,400 for the treatment at Redstone. If it does work, Paczosa said the therapy is less expensive in the long run than putting an animal on medication for extended periods of time to ease the pain from arthritis.

Other pluses, he said, are that the regenerative therapy isnt as invasive as surgery and anti-rejection drugs don't have to be used since the cells come from the same animal.More than one joint can also be treated at a time and it can eliminate the use of non-steroidal anti-inflammatory drugs.

The biggest risks are putting the animal under anesthesia and infection of the surgical site where the fatty tissue is removed, typically from the shoulder area or abdomen.

Stem cell therapy is practiced at a few hundred veterinary clinics in the country. Redstone works with the animal stem cell company MediVet Biologics and uses that companys in-house technology.

Paczosa said owners have come from other states to use the therapy at his Columbus clinic.

Initial results from the procedure lasts about two years. An option to bank stem cells from a pet is available. A portion of what is taken can be stored in a lab and used again in the future.

For Paczosa's patients, results have been quick and ongoing.

Most owners have seen a dramatic improvement in two weeks. Our first patient is still seeing improvements, he said.

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Stem cell therapy adds pep to pets - Liberty Tribune

TAMPA, Fla., Feb. 20, 2017 /PRNewswire/ -- StemedixInc., a U.S. based stem cell therapy group that specializesin the use of stem cells to treat patients with degenerative conditions, announced today that they are offering their patients a powerful treatment combination; Hyperbaric Oxygen Therapy (HBOT) and Stem Cell Therapy. According to research, the benefit of having HBOT treatments in conjunction with stem cell therapy is increasing the synthesis of nitric oxide, which signals the release of stem cells.

A recentstudyby researchers fromNeural Regeneration Researchfound results showing test subjects that underwent bothmesenchymalstem cell transplantation and HBOT had better neurological outcomes and better cognitive performance scores than subjects that endured only one type of treatment. Anotherstudyat the University of Pennsylvania School of Medicine, led by researcher StephenThom, MD, PhD, found that HBOT increases stem cell activity. After one treatment, the stem cell concentration doubled and after 20 treatments, they increasedeightfold.

Based on the growing interest and success, Fred Palmer, director of operations, at Stemedixsaid, "We are very proud to be working with the most recent and advanced technologies in the industry today. This combination of hyperbaric oxygen and stem cell therapies is progressively becoming the recommended treatment from our physicians and the selected treatment of our patients. Studies coupled with our own results we have seen thus far have been very impressive and supportive to our decision to offer this adjoining treatment."

Stemedix is now combining their stem cell therapy treatments with HBOT which allows for healing to occur that enables fibroblasts (tissue cells), capillaries (circulatory), osteoblasts (bone cells) andstem cellsto be stimulated. Without appropriate levels of oxygen in the tissue, healing cannot take place. With HBOT, oxygen is dissolved into all of the body's fluids, plasma, central nervous system fluids, lymph, and bone. In addition, the areas of the body that are lacking oxygen will begin to receive oxygen again.

To learn more about StemedixHBOT and stem cell therapy, contact Stemedixat 800-531-0831.

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SOURCE Stemedix, Inc.

http://stemedix.com

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Stem Cell Company Combining Stem Cell Therapy with Hyperbaric Oxygen Treatment - PR Newswire (press release)

TiGenix is using Lonza as a US CMO and Takeda as an ex-US commercialization partner to launch and trial its off-the-shelf stem cell therapy for a complication of Crohns disease.

TiGenix NV is a Belgian biotech developing a Phase III cell therapy Cx601 for a complication of Crohns Disease which has been licensed ex-US to Takeda Pharmaceutical Company Ltd.

Cx601 is based on stem cells taken from donor adipose tissue, as an allogenic off-the-shelf cell therapy product for the treatment of complex perianal fistulas in patients with Crohns disease patients who do not otherwise respond to standard therapies.

According to new data released today from thepivotal Phase III trial , Cx601 has reached its primary endpoint: long term remission ofperianal fistulas in patients with Crohns disease.

Wilfried Dalemans, CTO of TiGenix, told Biopharma-Reporter that TiGenix is also working with Lonza to facilitate a new trial for registering Cx601 in the states.

[Lonza] is now introducing our manufacturing process into their facilities in the US. Once the tech transfer is completed, they will produce clinical material,he told us.

TiGenix is developing Cx601 in the States after an agreement with the US FDA based on a special protocol assessment procedure (SPA) in 2015. Dalemans added:This is the first time we're working with a CMO in the US.

For the pivotal Phase III trial for Cx601 in the US, TiGenix will use the services of a US-based contract manufacturing organization, Lonza. This trial is expected to begin in the first half of 2017, and the firm has already begun the process of transferring our technology to them for the purpose to this trial.

Manufacturing Cx601

The Cx601 therapies are manufactured in a 2-dimensional cell culture in CF5, and according to Dalemans, do not yet need more sophisticated reactors.

To meet the manufacturing capacity for the European launch of Cx601, the current GMP facilities in Madrid are currently being expanded with the 50-50 financial support of Takeda.

Dalemans told us:We're using local service providers for the engineering of the facility extension. For the equipment, we are at this stage still selecting who we will use to supply instruments like incubators and laminar flows etc.

From the manufacturing site, the products arepackaged in special containers to maintain a temperature between 15 25 degrees centigrade for transport to the clinical site.

Cx601 is a living product - a suspension of living cells kept at room temperature. Because its not a frozen product, we do indeed need a cold chain supplier,he explained.

Takedas advice

Last July last year TiGenix partnered with Takeda to give the big pharma firm exclusive rights to commercialize Cx601 for complex perianal fistulas outside the US.

Luke Willats, a spokesperson for Takeda, told us:Takeda is a global leader in gastroenterology, [so] the acquisition of Cx601 is just a dedication and commitment to GI - and the related complications.

For these reasons, Takeda and TiGenix are working very closely in anticipation of the EMA approval, expected in the second half of 2017.

Dalemans explained: We're expanding our current Madrid facility to meet the capacity that will be needed once Takeda begins to commercialise Cx601 - we're also working closely with Takeda for even further extension of the capacity.

Willats told us that once authorization by the European regulators is obtained, Takeda will assume commercialization for Cx601 outside of the US.

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TiGenix hires Lonza to make cell therapy for Crohn's complications - BioPharma-Reporter.com

TAMPA, Fla., Feb. 20, 2017 /PRNewswire/ -- StemedixInc., a U.S. based stem cell therapy group that specializesin the use of stem cells to treat patients with degenerative conditions, announced today that they are offering their patients a powerful treatment combination; Hyperbaric Oxygen Therapy (HBOT) and Stem Cell Therapy. According to research, the benefit of having HBOT treatments in conjunction with stem cell therapy is increasing the synthesis of nitric oxide, which signals the release of stem cells.

A recentstudyby researchers fromNeural Regeneration Researchfound results showing test subjects that underwent bothmesenchymalstem cell transplantation and HBOT had better neurological outcomes and better cognitive performance scores than subjects that endured only one type of treatment. Anotherstudyat the University of Pennsylvania School of Medicine, led by researcher StephenThom, MD, PhD, found that HBOT increases stem cell activity. After one treatment, the stem cell concentration doubled and after 20 treatments, they increasedeightfold.

Based on the growing interest and success, Fred Palmer, director of operations, at Stemedixsaid, "We are very proud to be working with the most recent and advanced technologies in the industry today. This combination of hyperbaric oxygen and stem cell therapies is progressively becoming the recommended treatment from our physicians and the selected treatment of our patients. Studies coupled with our own results we have seen thus far have been very impressive and supportive to our decision to offer this adjoining treatment."

Stemedix is now combining their stem cell therapy treatments with HBOT which allows for healing to occur that enables fibroblasts (tissue cells), capillaries (circulatory), osteoblasts (bone cells) andstem cellsto be stimulated. Without appropriate levels of oxygen in the tissue, healing cannot take place. With HBOT, oxygen is dissolved into all of the body's fluids, plasma, central nervous system fluids, lymph, and bone. In addition, the areas of the body that are lacking oxygen will begin to receive oxygen again.

To learn more about StemedixHBOT and stem cell therapy, contact Stemedixat 800-531-0831.

References:

Related Images

image1.jpg

image2.png

image3.jpg

image4.jpg

Related Links

Stem Cell Therapy Results Videos

Stemedix

Related Video

This content was issued through the press release distribution service at Newswire.com. For more info visit: http://www.newswire.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/stem-cell-company-combining-stem-cell-therapy-with-hyperbaric-oxygen-treatment-300410046.html

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Stem Cell Company Combining Stem Cell Therapy with Hyperbaric Oxygen Treatment - Yahoo Finance

USA TODAY

AJ Foyt planning to undergo stem cell therapy USA TODAY Foyt, 82, told IndyCar.com Saturday during a Verizon IndyCar Series test at Phoenix International Raceway that he plans to undergo stem cell therapy, likely in Cancun, Mexico, with injections into both ankles and shoulders as well as his blood. Foyt ... Local Physician Offers Latest in Stem Cell TherapyPR Leap (press release) New Nanofiber Stem Cell Therapy Developed By Kyoto UniversityUniversity Herald Stem Cell Therapy Market Is Expected to Reach USD 60.94 Billion by 2022Satellite PR News (press release) Digital Journal all 12 news articles »

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AJ Foyt planning to undergo stem cell therapy - USA TODAY

TARPON SPRINGS, Fla. - Cosby just doesnt get around like he used to.

We have six dogs and hes always the one thats the last to get up. The last to get out, said his owner Brian Cirillo.

And for Cirillo, its sad to see.

I hate it. Its always like he always on his tippy topes on his back legs. So its heartbreaking.

But a new trial study that is about to start at the St. Francis Pet Care Center in Tarpon Springs, could be just what Cosby needs.

Veterinarian Mike Amsberry is offering stem cell therapy for dogs.

They are seeing that its very, very safe. And very effective.

This study is focused specifically on four-legged friends with arthritis.

But in the past hes seen stem cell treatments work wonders for other ailments.

Its cells treating the body, rather than then some foreign substance. Some medication.

In this trial, the stem cells come from umbilical cords of donor dogs.

Not only can qualified pets get the treatment for free, but owners are paid too.

Cosby seems like the perfect candidate.

I think thats where everything seems to be going with regard to medicine. So to be on the leading edge of that to potential help him without having to put him on a bunch of medicine is definitely a plus, said Cirillo.

The hope is one day Cosby will be able to keep up with the rest.

And lead the way to help thousands of other dogs.

For more information on the trial study go to petstemcells.org.

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Local vet taking part in stem cell therapy study for dogs - Story ... - ABC Action News