Category Archives: Stem Cell Clinic

Duluth Woman Meets, Finds Similarities with Stem Cell Donor – WDIO-TV

So how did they come together? It was less than 3 years ago that Edwards received the toughest news anyone can receive from a doctor.

"I was then diagnosed with leukemia, a rare form of leukemia," said Edwards.

The treatment for this rare form of blood cancer included multiple rounds of chemotherapy and radiation.

"All in all, it was enough toxins to kill a person if you ask me," said Edwards.

Edwards was also hoping to find help from someone else's blood.

"We started the search through Delete Blood Cancer and found a match," said Edwards.

The goal was to find a donor with a similar genetic makeup who could give Edwards their stem cells.

"We tried to match my brother and sister, but unfortunately there were not. So, we kept the search until we could find a match. It was a little nerve-racking, said Edwards.

That's where Halfkann comes in.

"I got a letter that I can be a stem cell donor, and I must go to the clinic in Cologne," said Halfkann.

Halfkann was already previously registered having signed up after one of her coworkers became ill. Although no successful matches were found back in Germany, in Minnesota, Halfkann was exactly who Merissa was looking for.

"Daniela is the only match in the world," said Edwards.

The news that Halfkann could save a stranger's life in the United States delighted the soft-spoken German.

"I'm so happy. I'm grateful," said Halfkann.

The stem cell procedure was pretty simple. Daniela donated blood. The stem cells were filtered out, then sent to Merissa in Minnesota where they were injected.

"There's a lot of complications after the stem cell transplant that could've gone wrong. Fortunately it didn't, which made Daniela an even more perfect match than she already is," said Edwards.

When Edwards heard about the woman who extended her life, she connected with Halfkann online.

"At first we wrote email, and then we connected on Facebook," said Halfkann.

After just a few notes, it was quickly discovered that the two have more in common than the blood running through their veins.

"We like a lot of the same things. Both have 2 children. Both of our husbands are firefighters," said Edwards.

And Edwards continues to successfully battle cancer.

"Right now I am in remission. That doesn't mean that I'll necessarily be cancer-free, but knock on wood...that's the goal...that the cancer will never come back," said Edwards.

There was only one thing left for Edwards to do; meet the woman and family that saved her life. So just a few weeks ago, the pair met for the very first time at Duluth International Airport.

"She is so nice. She is so lovely. I'm so happy we can be here," said Halfkann.

In the ten days together, they and their families created many memories. Halfkann got a glimpse of the life Edwards is now able to hold on to, and it wasn't long before the pair found more in common.

"We seem to like the same things...fruity tea, crafting, sewing, just similar interests in hobbies. Another common interest, shoes," said Edwards.

Both husbands also enjoyed their time together. At the firehouse, Merissa's husband, Dennis, giving Daniela's husband, Stefan, a tour of some of the American rigs and a ride along during an emergency call.

Back at headquarters, the crew made a home-cooked dinner for Halfkann's family and someone else who helped make all of this happen: Amanda Schamper, a representative of DKMS, the registry that matched Edwards and Halfkann.

"What we try to do is to raise awareness in all communities that this is a problem out there. People are searching for their donor match and can't find one," Schamper.

Schamper also showed everyone just how easy it is to sign up to be a bone marrow and stem cell donor.

"We do have a statistic that nearly 14,000 patients are told that they needed a transplant each year, and less than half can't get one because they can't find a donor match on the registry, said Schamper.

During the visit, Edward's extended family threw a get-together in honor of Halfkann. Edward's sister-in-law Kris Hansen is just as grateful.

"Just to know that she's here and they've met each other, and that she can save a life...it's incredible. It's nice to be able to see her and her family and her two adorable daughters," said Hansen.

Through the countless hugs at the party, family members repeated one phrase that transcends all languages.

"I guess the biggest thing we have to say is Danka Daniella!" said Hansen.

"Thank you for saving my life. Thank you for letting me be a Mom. Thank you for coming here so I can meet you and meet your beautiful children and your husband," Edwards said to Halfkann.

And with thanks, comes gratitude.

"I'll forever be grateful to you. You will always be a part of my family." said Edwards.

And this bond that will last a lifetime.

"We're forever connected," said Edwards.

"Yes. Forever," said Halfkann.

Edwards says she and her family are making plans to visit the Halfkann's in Germany.

If you're interested in signing up to become a bone marrow or stem cell donor, it's free and only takes a few moments. A link to that website can be found here.

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Duluth Woman Meets, Finds Similarities with Stem Cell Donor - WDIO-TV

Scientists Want to Grow Your Music-Blasted Ears Some New Parts – Gizmodo

Ear organoid with hair cells in blue. Image: Indiana University School of Medicine

Hearing loss can be inevitable for some older folks, as well as for their music blasting, phone screen-staring grandchildren. Naturally, many of those whove lost their hearing are keen on getting it back, somehow, with things like hearing aids and cochlear implants.

But what if your doctor could just turn some of your own bodys cells back into sound-sensing hair cells, and transplant them right back into your head?

A team of scientists at Indiana University might be getting closer to that future, using pluripotent stem cells, cells from the body that can be turned back into blank slate cells. The researchers were able to use these cells to create functioning pieces of the inner ear, chock full of hair cells and neurons. True stem cell hearing loss treatment is a long way off, but the result is, as far as they can tell, the first time anyones created hair cells from human pluripotent stem cells. So, a step in that direction.

Its exciting, study co-authors Jeffrey Holttold Gizmodo If were going to use these approaches in the clinic well want to start with human stem cell tissue.

Hearing loss can come from damage to elongated hair cells inside the ear that help with detecting sounds and relaying them to your brain. While some animals regenerate them, humans dont, and we can damage them from loud noises and aging.Scientists have been looking for methods like stem cells and gene therapies to repair them.

For their new study, the researchers started with human stem cells, arranged them in a sort of organic gel matrix like chunks of fruit in Jell-O, and tagged them with a fluorescent gene that would produce a glowing signature if theyd successfully produced certain cell types. They turned the stem cells into little pieces of inner ear by applying proteins at just the right time in a step-by-step process, and after a few weeks of tending to their cellular masses, were able to demonstrate that the little globs had developed into part of an ear. That included hair cells that both looked and acted properly, as well as neurons that send sound signals to the brain, according to results published yesterday in the journal Nature Biotechnology.

If you apply these signals at the wrong time you can potentially generate a brain instead of an inner ear, study author Karl Koehler told Gizmodo. The real breakthrough is that we figured out the exact timing to do each one of these [protein] treatments.

The researchers didnt implant the cells into a human patient or anything, but they still took a hugely important step. The idea, to be able to one day take a tube of blood and make your hair cells and implant is really exciting. I think its the future, Eric Topol, Founder and Director of the Scripps Translational Science Institute in California who was not involved in the study, told Gizmodo. Its a biological remedy to hearing loss.

It will take a long time to actually get to the transplanting stage, warned Holt and Koehler, and its been slow going. Other studies have used mouse cells or have been very preliminary, said Koehler. Its difficult to say whether or not well be able to use stem cell-derived cells to rebuild the inner ear.

Plus, these kinds of discussions always come along with ethical concerns. The World Health Organization suggests that over half of the worlds cases of deafness are preventable. Still, theres an entire American Deaf culture and identity that could be forgotten when we do research like this. Not all deaf people want to regain their hearing, according to reporting done by The Atlantic. I reached out to the National Association of the Deaf whose bioethics committee is looking at the paper, but does not have a response at this time.

Even if treatments like this are a long way off, growing these cells could be important for research, says Holtmainly to continue doing experiments. Its hard to get human inner ear hair cells otherwise. We cant get them from the patients and most people dont want to give up an ear for our experiments.

[Nature Biotechnology]

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Scientists Want to Grow Your Music-Blasted Ears Some New Parts - Gizmodo

The Anabolic Era of Orthopaedics: Stem Cells which ones to use? – Huffington Post

Orthopaedic Tissues transplanted into humans are dead.

Thats right: Other than hearts, livers and kidneys for that must be kept alive for immediate transplantation, any tissue that is removed from a donor or a cadaver, frozen, washed, sterilized and finally delivered to a surgeon is dead. From there it may be used in new ACL grafts, meniscus replacements, rotator cuff patches, tendons for the hands and feet the list goes on.

The surgeon relies on the patients healing ability to recognize and revive the dead donor graft. The body does this by sending scavenger cells that open up pores for the new blood vessels to bore into, lacing new blood vessels into the tissue, and finally sending specialized cells that lay down new collagen and restore the graft to life. In ligaments, this wonderful tissue regeneration process is called ligamentization; in other tissues, remodeling.

But the process of remodeling takes time, and during that period of restoration the tissue is at its weakest stage. A new injury doesnt need to be very forceful to tear the healing tissue. And any illness might slow down the process. An early return to sports might put too much stress on the graft, leading to stretchingor, in the worst case, a complete failure to remodel.

But why, in the 21st century, do we rely on nature alone to heal our repaired and replaced tissues? Fortunately, the entire field of tissue regeneration is changing rapidlyand the Stone Research Foundation is at the forefront of this research.

We are now in what I call the Anabolic Era of orthopedics, where we add stem cells, growth factors, electrical stimulation and other factors to juice up the healing process. But stem cell science is advancing so rapidly that we now have off-the-shelf products with the highest desirable concentrations of stem cells and growth factors for every application.

Stem cells are pluripotent cells that produce a wide range of healing growth factors, along with anti-inflammatory, anti-scarring, and antimicrobial agents. A 50-year-old person has 1/4 the stem cells of a teenager.

Over the last few years, in the Stone Clinic, we concentrated and combined patients own stem cells and growth factors with donor tissues before using them to rebuild ACLs and meniscus tissue. This year, we have off-the-shelf amniotic tissue with validated live cells and 2 to 50 times the growth factor concentrations that we can obtain from the patients own blood. These tissues also contain millions of cellsmany times more than the few found in older peoples bone and fat. These off-the-shelf cells are immunoprivileged, meaning they are not rejected (for the same reason a mother does not reject the baby she carries) and do not form tumors.

Here is a short table of the stem cell sources today:

Pros: very vascular with many cells

Cons: Requires a surgical procedure; cell numbers decline with age.

Pros: Marrow cells are more similar to cartilage and bone

Cons: Painful bone marrow biopsy procedure; cell numbers decline with age

Pros: easy access with a needle puncture. Less expensive. Growth factors 2-5x normal

Cons: Very few stem cells.

Amniotic Fluid and Membranes:

Pros: 2-50x growth factor concentration. Very high concentration of stem cells. No second surgery.

Cons: Cost. Many preparations have dead cells. Quality control essential. If irradiated then low activity of growth factors.

Today, tissues transplanted in our clinic are pre-loaded with these amniotic growth factors and stem cells. We must now do the basic science to determine the optimal concentrations of these factors when infused into tissues and the clinical science to demonstrate if, and how much faster, the body heals with the use of these tissues.and if effective enough the application of stem cells and growth factors may quickly become widespread, leading to accelerated tissue repair.

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The Anabolic Era of Orthopaedics: Stem Cells which ones to use? - Huffington Post

World’s 1st Stem Cell Transplant from Donor to Man’s Eye Shows Promise of Restoring Sight – EnviroNews (registration) (blog)

(EnviroNews World News) Kobe, Japan For more than two million Americans, straight lines may look wavy and the vision in the center of their eye may slowly disappear. Its called age-related macular degeneration (AMD), and there is no cure. But that may change soon.

A surgical team at Kobe City Medical Center General Hospital in Japan recently injected 250,000 retinal pigment epithelial (RPE) cells into the right eye of a man in his 60s. The cells were derived from donor stem cells stored at Kyoto University. It marked the first time that retinal cells derived from a donors skin have been implanted in a patients eye. The skin cells had been reprogrammed into induced pluripotent stem cells (iPS), which can be grown into most cell types in the body.

The procedure is part of a safety study authorized by Japans Ministry of Health that will involve five patients. Each will be followed closely for one year and continue to receive follow-up exams for three additional years. Project leader Dr. Masayo Takahashi at Riken, a research institution that is part of the study, told the Japan Times, A key challenge in this case is to control rejection. We need to carefully continue treatment.

A previous procedure on a different patient in 2014 used stem cells from the individuals own skin. Two years later, the patient reported showing some improvement in eyesight. But the procedure cost $900,000, leading the study team to move forward using donor cells. They expect the costs to come down to less than $200,000.

Among people over 50 in developed countries, AMD is the leading cause of vision loss. According to the National Eye Institute, 14 percent of white Americans age 80 or older will suffer some form of AMD. The condition is almost three times more common among white adults than among people of color. Women of all races comprise 65 percent of AMD cases.

The lack of a cure has led some to try unproven treatments. Three elderly women lost their sight after paying $5,000 each for a stem cell procedure at a private clinic in Florida. Clinic staff used liposuction to remove fat from the womens bellies. They then extracted stem cells from the fat, which were injected into both eyes of each patient in the same procedure, resulting in vision loss in both eyes. Two of the three victims agreed to a lawsuit settlement with the company that owned the clinic.

Stem cell therapy is still at an early stage. As of January 2016, 10 clinical uses have been approved around the world, all using adult stem cells. These include some forms of leukemia and bone marrow disease, Hodgkin and non-Hodgkin lymphoma and some rare inherited disorders including sickle cell anemia. Stem cell transplants are now often used to treat multiple myeloma, which strikes more than 24,000 people a year in the U.S.

Clinical trials to treat type 1 diabetes, Parkinsons disease, stroke, brain tumors and other conditions are being conducted. The first patient in a nationwide clinical study to receive stem cell therapy for heart failure recently underwent the procedure at the University of Wisconsin School of Medicine and Public Health. An experimental treatment at Keck Medical Center of USC last year on a paralyzed patient restored the 21-year-old mans use of his arms and hands. Harvard scientists see stem cell biology as a path to counter aging and extend human lifespans. But the International Society for Stem Cell Research warns that there are many challenges ahead before these treatments are proven safe and effective.

The U.S. Food and Drug Administration (FDA) regulates stem cells to ensure that they are safe and effective for their intended use. But, that doesnt stop some clinics from preying on worried patients. The FDA warns on its website that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.

While there is yet no magic cure for AMD, the Japan study and others may one day lead there. The Harvard Stem Cell Institute (HSCI) in Boston is currently researching retina stem cell transplants. One approach uses gene therapy to generate a molecule that preserves healthy vision. Another involves Muller cells, which give fish the ability to repair an injured retina.

But these therapies are far off. We are at about the halfway mark, but there is still a precipitous path ahead of us, Takahashi said.

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World's 1st Stem Cell Transplant from Donor to Man's Eye Shows Promise of Restoring Sight - EnviroNews (registration) (blog)

Cellular Dynamics Adds to Stem Cell Work With Harvard Institute … – Xconomy

Xconomy Wisconsin

Cellular Dynamics International, a Madison, WI-based manufacturer of human cells, recently signed a collaboration agreement with the Harvard Stem Cell Institute thats aimed at making greater quantities of stem cells available to researchers at the institute and its affiliates.

CDI concentrates in part on developing and commercializing therapiesusing induced pluripotent stem (iPS) cells, which can be differentiated into any type of cell found in the human body. These cells in turn have a wide array of applications in regenerative medicine; for example, they could be used to make photoreceptor cellsalso known as rods and conesor even to create whole retinas.

The company said that its goal in working with the HSCI is to make iPS cells and technology more accessible to the institutes network of researchers, who are scattered across hospitals and biomedical businesses based in the Boston area, as well as Harvard Universitys various schools.

Our intention is to partner with both pre-commercial and post-commercial partners and affiliates of HSCI to move these technologies to a higher scale and further toward technology productization, said Bruce Novich, executive vice president and general manager at CDI, in an e-mail to Xconomy.

CDI will design, develop, and manufacture new cell lines for HSCI-affiliated researchers, and provide them with on-site training and support, Novich said.

During the past couple years, CDI has collaborated with several of the HSCIs 200-plus faculty members, Novich said. The announcement of a more formal and extensive collaboration came last week.

Affiliates of the institute, which is funded exclusively by private philanthropy, include Massachusetts General Hospital, Beth Israel Deaconess Medical Center, and the Dana Farber Cancer Institute.

Novich said that the HSCIs distribution of cells today involves delivering starting materials, known as stem cell cores, to its partners and affiliates. CDI is entering the picture to offer scalable solutions to [researchers] to take [their] results to the next level, he said.

CDI, which has about 160 employees and plans to move into a new manufacturing facility in the next couple years, operates as a subsidiary of Tokyo-based Fujifilm. That company acquired CDI in 2015 for $307 million.

Novich, who is also a division president at Fujifilm North America, said that the companys investment in CDI has allowed it to significantly scale up cell production. Together, the two firmshave the ability to support and facilitate lab-to-clinic iPS cell-based programs, a category that Novich said includes some of the technologies being developed at the Harvard institute.

Jeff Buchanan is the editor of Xconomy Wisconsin. Email: jbuchanan@xconomy.com

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Cellular Dynamics Adds to Stem Cell Work With Harvard Institute ... - Xconomy

Stem cell clinics accused of promising more than they can deliver, and worse – Genetic Literacy Project

Its a nightmare story: Three women pay tens of thousands of dollars to a South Florida clinic for unproven stem cell therapy, only to end up blindcritics warn that theres a large and growing problem with patients being promised revolutionary stem cell therapy, only to find theyve wasted their moneyor worse.

Yet clinics around the world offer unregulated procedures, typically using fat cells that are removed from the patients body, treated, and injected back into itthe process that blinded the three women in South Florida.

And indeed, the confusion over what we actually can do with stem cells led the International Society for Stem Cell Research (ISSCR) last year to issue guidelines cautioning researchers against letting their work be misrepresented in the public eye.

Intertwined with that issue, though, is the lack of regulation that allows clinics to exploit patients ignoranceBecause the procedure extracts cells from the patients own body and only puts them through minimal treatment before reinjecting them somewhere else, the FDA does not consider it a drug treatment. Its outside the agencys purview.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Stem Cell Clinics Are Ruining Peoples Lives

For more background on the Genetic Literacy Project, read GLP on Wikipedia

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Stem cell clinics accused of promising more than they can deliver, and worse - Genetic Literacy Project

Oz: Hard work, exercise and diet can control diabetes – Pueblo Chieftain

Q: I hear there's a clinic in Canada that can medically cure type 2 diabetes without bariatric surgery. I was diagnosed two years ago. Is this true? -- William T., Bozeman, Mont.

A: It's almost true. Because type 2 is a chronic disease, when you have the disease down and out for the count, it's referred to as being in remission, not cured; the reasoning is, it could come back.

That said, a group of researchers from McMaster University in Ontario, Canada, achieved a three-month remission of type 2 diabetes for 40 percent of the people in one of their trial groups.

For the trial, 83 volunteers with type 2 diabetes were divided into three groups: For 16 weeks, members of one group received intense, personalized intervention, including an individual exercise routine, a meal plan cutting food intake by 500-750 calories daily and treatment with metformin, acarbose (an oral alpha-glucosidase inhibitor that lowers blood glucose) and insulin glargine. They also saw a nurse and dietitian regularly.

The second group received the same treatment for eight weeks.

And the third (control) group received standard blood-sugar management and health advice.

At the end of the trial, participants in the two intensive-treatment groups discontinued their medications. In the 16-week intervention group, 11 of 27 participants showed complete- or partial-remission three months later. In the eight-week intervention group, six of 28 saw those results. But remember, this is a trial, not an accepted therapeutic approach.

There are solutions, however. Regular physical activity, avoiding the five food felons, losing 5 to 10 percent of your body weight and taking prescribed medications can reverse type 2 diabetes in over half of participants with early type 2 diabetes or prediabetes. This Canadian study also demonstrates that with hard work, William, you can defeat your diabetes. We hope you're successful.

Q: I've developed age-related macular degeneration. Are stem cell treatments a viable option? -- Gladys G., Miami

A: Stem cell treatments for age-related macular degeneration (AMD) are not ready for prime time.

In 2014, a small study looked at using pluripotent stem cell therapy for dry AMD and found that it might be viable. The first stem cell clinical trial for wet macular degeneration was launched in 2015. A 2016 study in Investigative Ophthalmology & Visual Science concluded: "stem cell-based therapies for non-neovascular AMD are emerging and several clinical trials are in progress. However, there are major regulatory, safety and technical challenges that remain."

Why should you be wary? The New England Journal of Medicine reports on three women who received stem cell therapy for AMD at a clinic in Florida. Two of them checked listings of clinical trials on the website clinicaltrial.gov. They "enrolled" in the Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration. The sponsor was one of hundreds of unregulated for-profit stem cell therapy centers in the U.S. The third woman went directly to the company for treatment.

Their outcomes were horrifying.

The facility charged each woman $5,000. (Red flag: Legitimate clinical trials never ask for payment!) The company's staff then injected stem cells made from each woman's fat cells into her eyes. One woman went completely blind and two are virtually blind.

How do you know if a clinical trial is legit? It should be conducted by a reputable nonprofit research center or hospital/medical center and be free.

How do you know if a stem cell treatment is legit? Ask centers of medical excellence, like the Cleveland Clinic's Cole Eye Institute or The Harkness Eye Institute/CUMC, if they offer such treatments. If they don't, you shouldn't get them elsewhere.

Even some stem cell treatment businesses know they're unreliable. Here's a disclaimer we found on the Internet: "All claims made regarding the efficacy of ... treatments ... are based solely on anecdotal support collected by [the company]." In other words, no scientific evidence backs up their claims.

Mehmet Oz, M.D. is host of "The Dr. Oz Show," and Mike Roizen, M.D. is Chief Medical Officer at the Cleveland Clinic Wellness Institute. Submit your health questions at http://www.youdocsdaily@sharecare.com.

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Oz: Hard work, exercise and diet can control diabetes - Pueblo Chieftain

General American Capital Partners Invests up to $5 Million in U.S. Stem Cell, Inc. – Yahoo Finance

SUNRISE, FL / ACCESSWIRE / April 13, 2017 / U.S. Stem Cell, Inc. (USRM), a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, has received a commitment to invest up to $5,000,000 from private equity firm General American Capital Partners LLC (GACP) in exchange for up to 63,873,275 shares of common stock.

"We see exponential growth in the stem cell industry, estimated to grow to $170 billion by 2020," said Joseph DaGrosa, Jr., a Principal with General American Capital Partners. "We are very pleased to join forces with U.S. Stem Cell, Inc., a leader in regenerative medicine solutions, to help expand our role in this important market."

The 21st Century Cures Act, signed into effect in December of 2016, builds on the FDA's ongoing efforts to advance medical product innovation and ensure that patients get access to treatments as quickly as possible, with continued assurance from high quality evidence that they are safe and effective.

"Patient demand for regenerative medicine procedures as a viable alternative to surgery, as well as the transformative capacity of stem cell therapies, are leading the way to increased acceptance by both the medical and regulatory communities," said Mike Tomas, President and CEO of U.S. Stem Cell, Inc.

About U.S. Stem Cell, Inc.

US Stem Cell, Inc. (formerly Bioheart, Inc.) is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development, and commercialization of cell based therapeutics that prevent, treat, or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases, ultimately, we contend, lessening patient burdens, as well as reducing the associated economic impact disease imposes upon modern society.

Our business, which includes three operating divisions (US Stem Cell Training, Vetbiologics, and US Stem Cell Clinic) includes the development of proprietary cell therapy products, as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities, as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.

Forward-Looking Statements:

Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue," or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.

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U.S. Stem Cell, Inc. 13794 NW 4th Street, Suite 212 Sunrise, Fl 33325 Phone: 954.835.1500 Email: usstemcell@us-stemcell.com

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General American Capital Partners Invests up to $5 Million in U.S. Stem Cell, Inc. - Yahoo Finance

First Clinic-Ready Stem Cell Repository – The Scientist


The Scientist
First Clinic-Ready Stem Cell Repository
The Scientist
WELLCOME IMAGES, ANNIE CAVANAGHIn an effort to make it easier for researchers to develop stem cellbased therapies, the UK Stem Cell Bank is offering several ready-to-go human embryonic stem cell (hESC) lines derived from donated tissue that ...
Can Stem Cell 'Patch' Help Heart Failure?WebMD
Island Animal Hospital Offers Stem Cell TherapyBeachside Resident
Experimental muscle-cell 'patches' may hold promise for failing heartsReuters

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First Clinic-Ready Stem Cell Repository - The Scientist

Study points to dangers in unproven stem cell treatments in local clinics – Miami’s Community Newspapers

Three South Florida women suffered serious loss of vision soon after receiving stem cell treatments for age-related macular degeneration (AMD) at a Broward clinic in 2015, according to a study published today recently in the New England Journal of Medicine.

The retinal detachments, bleeding in the eyes and other blinding complications in these three patients raise concerns about stem cell clinics that charge patients for their services and that lack clinical data to support their practices, said Thomas Albini, MD, associate professor of clinical ophthalmology at Bascom Palmer Eye Institute and co-author of the study.

Albini said the three patients ages 72, 78 and 88 were concerned about losing their independence, including the ability to drive, due to AMD, a disorder that involves the gradual loss of the eyes photoreceptor cells and the leading cause of vision loss among elderly patients in the United States.

Patients seeking stem cell treatments for medical problems should only consider a carefully controlled clinical trial at an academic medical center, Albini said. Paying thousands of dollars to a local clinic for an unproven stem cell treatment as these patients did is extremely risky with a low probability of a successful outcome.

Five other Bascom Palmer physicians were co-authors of the study, Vision Loss after Intravitreal Injection of Autologous Stem Cells for AMD, in the journal: Ajay E. Kuriyan, MD; Justin H. Townsend, MD; Marianeli Rodriguez, MD, PhD; Philip J. Rosenfeld, MD, PhD; and Harry W. Flynn Jr., MD. Other co-authors were faculty members from the University of Rochester Medical Center; Dean McGee Eye Institute, University of Oklahoma; Center for Sight, Sarasota, and Byers Eye Institute, Stanford University.

In the study, the Bascom Palmer ophthalmologists discussed how the Broward clinic (its name was not disclosed) first harvested stem cells from the adipose fat tissues of the three patients and then injected the cells into both eyes of each patient.

Within 36 hours of their treatment at the Broward clinic, two of the three patients sought emergency care at Bascom Palmer for serious blinding conditions including ocular hypertension, vitreous hemorrhage, retinal detachment, and/or lens dislocation. Although the patients had suffered only moderate vision loss prior to their treatment, a year later their visual acuities ranged from 20/200 to total blindness.

While numerous stem cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem cell clinics are treating patients without that oversight and with potentially little concern for patient safety, Albin isaid. In this instance, these patients paid $5,000 each for a procedure that had never been studied in a clinical trial for possible improvement of vision.

Albini said the patients might have developed vision loss from retinal or optic nerve toxicity from the injected stem cells, enzymes or other materials, or from elevated intraocular pressure (IOP), which damages the optic nerve.

Several cellular therapy approaches are now being investigated by U.S. Food and Drug Administration (FDA) registered and Institutional Review Board (IRB) approved clinical trials, according to the study.

As of Nov. 2, 2016, at least 13 trials were registered on ClinicalTrials.gov studying the role of intravitreal injections of various stem cell populations. However, Albini cautioned that not every trial registered on the site has been approved by an IRB or the FDA.

Some clinics are claiming that treatments using the patients own stem cells dont require FDA oversight or clinical trials, even though there is no evidence the treatments are safe or effective, he said. Almost all legitimate research is funded by an institution or company with an established protocol, lots of pre-clinical data and extensive pre-trial and post-trial evaluations.

For information on Bascom Palmer Eye Institute, contact Marla Bercuson at 305-326-6190 or send email to mbercuson@med.miami.edu, or visit http://www.bascompalmer.org.

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Study points to dangers in unproven stem cell treatments in local clinics - Miami's Community Newspapers