Category Archives: Florida Stem Cells

Adult stem cells circulate throughout or body and are also found in large numbers in the bone marrow and fat cells. Stem cells act as natural healers and have vast potential and almost limitless capabilities. They are the repairmen of the body. Recent advancements in stem cell therapy have allowed the use of stem cells for orthopedic treatment.

Adult stem cell therapy involves the use of a patients own cells (autologous) with no possibility of the body rejecting the new tissue formed. Therefore, stem cell therapy is very safe and very effective. This treatment allows the body to take advantage of the normal healing pathways at a greatly accelerated rate.

Stem cell therapy is routinely combined with platelet rich plasma (PRP). This is a concentrate of platelets from the patients own blood. Among the effects of platelets is the release of growth factors into diseased or injured tissue. These growth factors stimulate the stem cells to regenerate new tissue. This innovative treatment can be used to regenerate articular cartilage and/or collagen in tendons and ligaments. The use of stem cells combined with concentrated platelets result in a powerful treatment for ostroarthritis, sports injuries, and spinal disorders.

Stems cells are collected by either aspirating the bone marrow from the back of the patients pelvis using a small needle, or by collecting fat cells from the abdomen. Both types of aspiration can be performed in an office setting with local anesthesia and with little or no discomfort. The aspirate is then placed in a centrifuge which spins it at high speed to separate the stem cells from the rest of the bone marrow aspirate. The concentration of stem cells, called bone marrow aspiration concentrate (BMAC), is then injected close to the injured or diseased tissue using ultrasound or x-ray guidance.

Stem cells by themselves are not capable of repairing the area. They need to be directed, and the platelets are the directors. Once activated, the stem cells are capable of addition to repairing the damage, the stem cells encourage damaged cells to repair themselves and also take part in the repair process.

Stem cell therapy is a repair process than takes several weeks to occur . Even though the repair can take 2-3 months, improvement of pain and function can be seen much earlier. An adequate environment for healing improves the results of stem cell therapy. For that reason, the use of nutritional supplements including Vitamin D3, carnosine, and green tea extract is highly recommended.

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Florida Stem Cell Treatments - Regenerative Orthopedic ...

Cardiac-Pulmonary Conditions

Led by Melvin M. Propis, M.D., South Florida Stem Cell Center is one of theleading Stem Cell Regenerative Therapy Clinics in South Florida. Dr. Propis is a seasoned M.D. and surgeon who has had solid success rates.

Stem Cell Regenerative Therapy is a breakthrough in medical science that treats and prevents conditions and diseases using stem cells. This is accomplished by harvesting cells and then concentrating those cells in a lab before precisely re-injecting them. This greatly increases your bodys own natural repair cells and promotes healing.

South Florida Stem Cell Center is made up of research scientists and experts in Stem Cell Therapy.Our passion and belief is that our treatments truly helpthose that are suffering and need our help.

Maribella MKnee Injury

I injured both of my knees. After confirming that the cartilage was still in the joint, Dr. Propis injected my knees with a mixture of stem cells and PRP 4 months ago. Today I walk comfortably, No pain in those joints. I have noticed significant improvement in my balance and no longer need a walker or narcotics for pain.

Mia HCrohn's Disease

I have had Crohns disease for most of my short life which has led me to miss out on many teenage activities. After seeing other patients improve from having stem cells injected, I (and my mother) decided to try it. It was a wonderful thing to gradually be able to discontinue giving myself Humara shots routinely. I can actually have an active social life without worrying and even married the love of my life last year. Thanking my doctor, mom, God, and the many people who believe in stem cells for my happy ending!

George BDiabetes

I flew to the US in hopes of getting help for my diabetes. Having tried medicine & diets with no results, I was ready to try stem cells. After 1 treatment (and a six month period) I am off all meds and not considered diabetic anymore. To me, life changing! Especially after a relatively simple procedure. Thank you to the office of Dr. Propis and staff.

We Specialize In Treating:

Immunological Conditions

A chronic inflammatory bowel disease that affects the lining of the digestive tract.

Widespread muscle pain and tenderness.

A chronic inflammatory disorder affecting many joints, including those in the hands and feet.

An inflammatory disease caused when the immune system attacks its own tissues.

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Neurological Conditions

A congenital disorder of movement, muscle tone, or posture.

Damage to the brain from interruption of its blood supply.

A progressive disease that destroys memory and other important mental functions.

A disease in which the immune system eats away at the protective covering of nerves.

A disorder of the central nervous system that affects movement, often including tremors.

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Degenerative Conditions

Damage to any part of the spinal cord or nerves at the end of the spinal canal.

A chronic condition that affects the way the body processes blood sugar (glucose).

Kidney Failure (Renal Failure)

A condition in which the kidneys lose the ability to remove waste and balance fluids.

A type of arthritis that occurs when flexible tissue at the ends of bones wears down.

Occurs when a man can't get or keep an erection firm enough for sexual intercourse.

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South Florida Stem Cell Center | Melvin M. Propis, M.D.

Stem cells are one of the most fascinating areas of biology today. But like many expanding fields of scientific inquiry, research on stem cells raises scientific questions as rapidly as it generates new discoveries. Although Florida has become a world-leader in stem cells research, the state is still in the clinical trial phase and therapies have not been legally approved yet. Stem Cells Transplant Institute in Costa Rica, is a great opportunity for you to access stem cells therapies for many diseases like Diabetes, COPD, Alzheimers Disease and many others, with the highest standard of quality. Apply now

Costa Rica has a unique geographic location, with beautiful pristine beaches, lush green mountains formed by past volcanic eruptions, dense rainforests, lakes, and rivers. All these help support one of the most diverse plant and animal life on the planet in addition to one of the best health care systems in the World. We want to offer our patients from Jupiter Island, Manalapan, Palm Beach, Naples, Key Biscayne, Sanibel a unique experience! Get more information about stem cells therapies in Costa Rica. Now

The World Stem Cell Summit will be held in West Palm Beach, Florida at the Palm Beach County Convention Center in 2016. The summit focuses on the latest scientific discoveries and research involving the use of stem cells. It attracts more than 250 scientists, business leaders, investors, policy-makers, patient-advocates and others.

Florida is one of the fastest growing bioscience regions in the world. With a strong base of biotechnology, medical devices and pharmaceutical companies, world-class research universities and some of the leading non-profit research institutes in the world, Florida has built a resource base to be a top bioscience destination. However stem cells therapies are not legally approved yet in Florida.

The Stem Cells Transplant Institute of Costa Rica specializes in the legal treatment of Neuropathy, Cardiovascular Disease, Myocardial infarction, Alzheimer, Parkinson, Lupus, Chronic Obstructive pulmonary disease, Diabetes, Rheumatoid Arthritis, Osteoarthritis, Knee Injury, Erectile Dysfunction and Multiple Sclerosis.

Extending life and improving the quality of ones existence are clearly part of our goals. Stem cell research and therapies vividly attest to the fact that the future is now. Floridas bioscience has a major role to play in this exciting transformation, not just regionally but nationally. You dont have to wait more to become a living-proof, at Stem Cells transplant institute we make available for you the best human resource and top technologies, to discover yourself the potential of stem cells. Get legally approved therapiesApply now

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Florida - Stem Cells Transplant Institute

A South Florida clinic that promotes controversial stem-cell treatments for a wide range of ailments is among the centers receiving a written warning that it is violating federal public health laws.

The U.S Food and Drug Administrations letter was addressed to Dr. Thomas A. Gionis, owner and chief surgeon of the Miami Stem Cell Treatment Center located in Boca Raton. Gionis also owns a stem cell treatment center in Irvine, Calif.

The letter shows that a third Gionis clinic in New York City apparently closed after FDA inspections of all three clinics was carried out from July through September 2015.

Dr. Gionis facilities are among more than 170 clinics across the country that are selling experimental stem cell procedures for dozens of diseases and conditions a mushrooming industry that has flourished despite little evidence of its safety or effectiveness.

Descriptions on the website say that Dr. Gionis and other practitioners inject or infuse a liquid that is said to contain stem cells derived from the patients own fat tissue, removed through liposuction. The clinic lists a large number of illnesses for which it says the treatments are appropriate, including: heart and lung disease, stroke, multiple sclerosis, spinal disc disease and auto-immune problems like lupus.

And his clinics are not the only ones operating in Florida. Internet search indicates this type of stem-cell treatment is available at clinics in Jacksonville, Orlando, St. Petersburg, Sunrise and a number of other sites throughout the state.

The rise of the U.S. stem cell industry illustrates how quickly fringe medicine can outpace government oversight. Over the last five years, academic stem cell researchers say they have watched in dismay as doctors treat patients with experimental techniques that they say could take years, if not decades, to become sound medicine.

"It's sort of this 21st century cutting-edge technology. But the way it's being implemented at these clinics and how it's regulated is more like the 19th century. It's a Wild West," says Dr. Paul Knoepfler, a stem cell researcher at the University of California at Davis.

The FDA letter to Dr. Gionis, dated Dec. 30, provides some insight into how the FDA is addressing the issue. In difficult-to-parse language, it says that the substance that Gionis is processing and injecting amounts to a drug that has not been approved for safety and usefulness.

The writer, Mary Malarkey, director of an office in the FDAs Center for Biologics and Research, says that if Gionis maintains his treatments are part of a clinical trial, as his website suggests, he would need to submit an Investigational New Drug (IND) application to FDA.

The FDA official says an earlier defense by the clinic that the chemical used in the mixture has been changed doesnt make it acceptable without more information.

Health News Florida was not able to reach Dr. Gionis on Monday, but left a message with his staff.

The Associated Press reported last May that entrepreneurial ventures using fat-derived stem cells have proliferated throughout the country. Scientists engaged in authorized stem-cell research said states have not stepped up to regulate the ventures and called on FDA to do so.

The FDA has scheduled a public hearing for April on draft guidelines for fat-derived stem-cell treatments that the agency released a few months ago. That led some to mistakenly think the treatments are being subjected to new regulations, said FDA spokeswoman Sarah Peddicord. She said the regulations went into effect in 2005.

The law has not changed, she said. What the agency released are guidelines that FDA hopes will help the industry and the public understand the law.

People need to understand how to implement the regulations, she said. The guidelines are just to explain the regulations.

Stem cells have long been recognized for their ability to reproduce and regenerate tissue. And while there are high hopes that they will someday be used to treat a range of debilitating diseases, critics say stem cell entrepreneurs have little more than anecdotes to support their offerings.

In 2010, there were only a handful of doctors promoting stem cell procedures in the U.S., mainly plastic surgeons promoting "stem cell facelifts" and other cosmetic procedures. But today there are clinics throughout the country promoting stem cells for dozens of conditions and diseases, including Alzheimer's, arthritis, erectile dysfunction and hair loss. The cost of these procedures is high, ranging from $5,000 to $20,000.

Many of the businesses are linked in large, for-profit chains which offer doctors the chance to join the franchise after taking a seminar and buying some equipment.

The largest of these chains is the Cell Surgical Network, co-founded in 2012 by Dr. Mark Berman, who spent 30 years as a Beverly Hills plastic surgeon before working with stem cells. His company offers stem cell procedures for more than 30 diseases and conditions, including Lou Gehrig's disease, multiple sclerosis and arthritis.

He and his partner adapted technology from Asia into a liposuction-based procedure in which fat is pumped out of patients' abdomen, processed with drugs and equipment and then injected back into the body.

Berman says this fat-based "soup," is rich in shape-shifting stem cells that have the potential to treat everything from neurological diseases to achy joints.

"I don't even know what's in the soup," says Berman. "Most of the time, if stem cells are in the soup, then the patient's got a good chance of getting better."

The clinics insist that their treatments are safe, but routinely require that patients sign waivers.

Patients of Dr. Zannos Grekos, a Florida cardiologist specializing in stem cell therapy, were also required to sign a consent form, acknowledging the procedures' risks, including death.

But families of two Grekos patients who died under his care say he downplayed the risks. Gina Adams, daughter of patient Richard Poling, says her family was told her father would be "back on the golf course the next day" after a procedure intended to treat a lung condition that made breathing difficult. The cost was $8,000.

In March 2012, Grekos harvested fat from Poling's abdomen and sent it to an off-site processing facility to isolate the stem cells. Later that afternoon, he directed an assistant to infuse the resulting mixture into the patient's bloodstream.

Poling suffered cardiac arrest and was pronounced dead after being rushed to a local hospital.

Two years earlier, in 2010, 69-year old Domenica Fitzgerald suffered a stroke after Grekos infused unfiltered bone marrow-derived stem cells into the arteries of her brain. The state report concluded "it was virtually inevitable that the procedure would clog blood vessels in the brain and cause a major and very possibly fatal stroke." Fitzgerald suffered severe brain damage and was removed from life support several days later.

Jack Fitzgerald says his wife, who used a wheel chair, had hoped that stem cells might help her walk again.

Not until 2013, after Poling's death, did the Florida Board of Medicine vote to revoke Grekos' license.

Though barred from practicing medicine in Florida, Grekos continues to treat patients in the Dominican Republican through his company Regenocyte, which promotes treatments for autism, dementia and many other diseases.

He believes the two deaths were unrelated to his care the state targeted him to discourage other doctors from working with stem cells, he says.

State actions against stem cell doctors are rare. That's led industry critics to conclude that regulation must come from the FDA, which regulates medical products on a national level.

But the FDA's authority to regulate stem cell procedures is not clearly defined and has been debated by legal experts for years.

Now, the FDA appears to be stepping up its oversight. In the last days of 2014, it released draft guidelines dealing with the popular fat-based stem cell technique. The agency said that processing fat to extract stem cells for medical use essentially creates a new drug, which cannot be sold in the U.S. without the agency's approval.

But many stem cell doctors continue to argue that they don't need FDA permission because they are not creating drugs, but performing in-office surgical procedures.

For now, Berman says he has no plans to change his business.

"How is it unethical if you're actually helping people, even if we don't have evidence-based studies to prove it?" he asks.

Carol Gentry is a special correspondent for WUSF in Tampa. Health News Florida receives support from the Corporation for Public Broadcasting.

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FDA: Florida Stem Cell Clinic Violates Law | Health News ...

Definition

A stem cell is a generic cell that can make exact copies of itself indefinitely. A stem cell has the ability to make specialized cells for various tissues in the body, such as heart muscle, brain tissue, and liver tissue. Stem cells can be saved and used later to make specialized cells, when needed.

There are two basic types of stem cells:

Regenerative medicine - stem cells

POTENTIAL USES FOR STEM CELLS

There are many areas in medicine in which stem cell research could have a significant impact. For example, there are many diseases and injuries in which a person's cells or tissues are destroyed and must be replaced by tissue or organ transplants. Stem cells may be able to make brand new tissue in these cases. They may even cure diseases for which there currently is no good therapy. Diseases that could be helped by stem cells include:

Stem cells could also be used to gain a better understanding of how genetics work in the early stages of cell development. This can help scientists understand why some cells develop abnormally and lead to medical problems, such as birth defects and cancer. In the future, scientists may be able to prevent some of these diseases.

Stem cells may also be useful in the testing and development of drugs. Because stem cells can be used to create unlimited amounts of specialized tissue, such as heart tissue, it may be possible to test how medicines react on such tissues before testing the medicines on animals and humans. Medicines could be tested for effectiveness and side effects more rapidly.

CONTROVERSY ABOUT STEM CELL RESEARCH

In August 2001, President George W. Bush approved limited federal funding for stem cell research. While stem cell research has the potential to provide major medical advances, including cures for many diseases, stem cell research is controversial.

The stem cell controversy is based on the belief by opponents that a fertilized egg is fundamentally a human being with rights and interests that need to be protected and fetuses and fertilized eggs should not be used for research. However, a team of scientists have developed a technique that was successful in generating mouse stem cells without destroying the mouse embryo. This technique has not yet been attempted on human embryonic tissue. Many other scientists are attempting to create more universally accepted forms of human embryonic stem cells, as well as other types of adult stem cells.

Supporters of stem cell research argue that the fertilized eggs are donated with consent from each couple and would be discarded anyway. Therefore, there is no potential for those fertilized eggs to become human beings. Fertilized eggs are not (at this time) being created specifically for stem cell research.

The US government released new stem cell guidelines in 2009. The new guidelines cover issues such as informed consent of donors and the wording of consent, as well as the issue of financial gain. The National Institutes of Health (NIH) maintains a register of stem cells, including human embryonic lines that are eligible for government funding.

Lawsuits challenging the use of stem cells have ruled in favor of the government.

Buzhor E, Leshansky L, Blumenthal J, et al. Cell-based therapy approaches: the hope for incurable diseases. Regen Med. 2014;9(5):649-672. PMID: 25372080 http://www.ncbi.nlm.nih.gov/pubmed/25372080.

Gepstein L, Skorecki K. Regenerative medicine, cell, and gene therapies. In: Goldman L, Schafer AI, eds. Goldman-Cecil Medicine. 25th ed. Philadelphia, PA: Elsevier Saunders; 2016:chap 44.

National Institutes of Health. National Institutes of Health guidelines on human stem cell research. 2009. Stemcell.nih.gov Web site. stemcells.nih.gov/policy/pages/2009guidelines.aspx. Accessed November 16, 2016.

Research America. Stem cell research FAQs. Researchamerica.org Web site. http://www.researchamerica.org/advocacy-action/issues-researchamerica-advocates/stem-cell-research/stem-cell-research-faqs. Accessed November 16, 2016.

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Stem cell research | UF Health, University of Florida Health

A Florida stem cell clinic has been cited by the U.S. Food and Drug Administration for what the agency describes as serious problems that could pose health risks to patients.

The agency said Monday that it has cited US Stem Cell Clinic, of Sunrise, for marketing stem cell products without FDA approval and for "significant deviations from current good manufacturing practice requirements," including some that could affect the "sterility of their products, putting patients at risk."

"Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk," FDA Commissioner Dr. Scott Gottlieb said in a news release.

The FDA said it recently inspected US Stem Cell Clinic and found that it was processing fat tissue into stem cells derived from body fat and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious health problems. Those problems included Parkinson's disease, amyotrophic lateral sclerosis (Lou Gehrig's disease), chronic obstructive pulmonary disease (COPD) and heart disease, among others.

The FDA said it hasn't approved any biological products made by US Stem Cell Clinic for any use.

During an inspection, FDA investigators also found evidence of "significant deviations from current good manufacturing practices" in the production of at least 256 lots of stem cell products. Those deviations included "failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections."

US Stem Cell Clinic also tried to hamper the FDA's investigation during a recent inspection "by refusing to allow entry except by appointment and by denying FDA investigators access to employees," the agency said.

Interfering with an FDA inspection is a violation of federal law, the agency said.

The FDA said it wants to hear from US Stem Cell Clinic within 15 working days, detailing how the problems cited in the agency warning letter will be fixed. If the problems aren't corrected, the company faces such enforcement actions as seizure, injunction or prosecutions, the agency said.

Any adverse events suffered by patients treated at US Stem Cell Clinic should be reported to the FDA's MedWatch Adverse Event Reporting program.

WebMD News from HealthDay

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FDA: Serious Problems at Florida Stem Cell Clinic - WebMD

The Food and Drug Administration is cracking down on "unscrupulous" clinics selling unproven and potentially dangerous treatments involving stem cells.

Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.

"There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb said in a statement Monday.

The FDA has taken action against clinics in California and Florida.

The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for "marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements."

The clinic is one of many around the country that claim to use stem cells derived from a person's own fat to treat a variety of conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases, the FDA says.

The Florida clinic had been previously linked to several cases of blindness caused by attempts to use fat stem cells to treat macular degeneration.

The FDA also said it has taken "decisive action" to "prevent the use of a potentially dangerous and unproven treatment" offered by StemImmune Inc. of San Diego, Calif., and administered to patients at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif.

As part of that action, the U.S. Marshals Service seized five vials of live vaccinia virus vaccine that is supposed to be reserved for people at high risk for smallpox but was being used as part of a stem-cell treatment for cancer, according to the FDA. "The unproven and potentially dangerous treatment was being injected intravenously and directly into patients' tumors," according to an FDA statement.

Smallpox essentially has been eradicated from the planet, but samples are kept in reserve in the U.S. and Russia, and vaccines are kept on hand as a result.

But Elliot Lander, medical director of the California Stem Cell Treatment Centers, denounced the FDA's actions in an interview with Shots.

"I think it's egregious," Lander says. "I think they made a mistake. I'm really baffled by this."

While his clinics do charge some patients for treatments that use stem cells derived from fat, Lander says, none of the cancer patients were charged and the treatments were administered as part of a carefully designed research study.

"Nobody was charged a single penny," Lander says. "We're just trying to move the field forward."

In a written statement, U.S. Stem Cell also defended its activities.

"The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration," according to the statement.

"We have helped thousands of patients harness their own healing potential," the statement says. "It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

But stem-cell researchers praised the FDA's actions.

"This is spectacular," says George Daley, dean of the Harvard Medical School and a leading stem-cell researcher. "This is the right thing to do."

Daley praised the FDA's promise to provide clear guidance soon for vetting legitimate stem-cell therapies while cracking down on "snake-oil salesmen" marketing unproven treatments.

Stem-cell research is "a major revolution in medicine. It's bound to ultimately deliver cures," Daley says. "But it's so early in the field," he adds. "Unfortunately, there are unscrupulous practitioners and clinics that are marketing therapies to patients, often at great expense, that haven't been proven to work and may be unsafe."

Others agreed.

"I see this is a major, positive step by the FDA," says Paul Knoepfler, a professor of cell biology at the University of of California, Davis, who has documented the proliferation of stem-cell clinics.

"I'm hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell "treatments" that may not be real treatments," Knoepfler says.

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FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments - KRCB

NICEVILLE, Fla. (AP) Jack Massey is ready to go back to school.

Only this time, the University of Florida senior will head back to campus with his mom and a new outlook on life.

Massey suffered a spinal cord injury in a pool accident in March and is paralyzed from the chest down. After months of rehab, hes eager to get back into a familiar routine.

Its definitely boring, the 21-year-old said at his parents home in Niceville. Theres not a lot to do. I want to go back to school. I still have my brain. I still have everything I need to be successful.

After the accident March 17, Massey was treated at the University of Florida Shands Hospital and then was transferred to Shepherd Center, a spinal cord and brain injury rehab center in Atlanta. At Shepherd Center he met with a peer mentor, counselors and physical therapists to help him find a new normal.

Jack has remained positive throughout the past six months.

Jack has been a fighter through all of this, said his mother, Julie. I think hes done well. I only saw him break down once.

Before the accident, Jack was a well-rounded athlete who playing baseball and basketball and ran. He was a star on the track and field team at Niceville High School in Florida, with his 4 X 800 relay winning state his senior year.

He says the biggest challenge now is not being able to do the same things he could before.

I cant get up and go, he said. It didnt really start to set in until after I got out of rehab.

Jack has had to find enjoyment in other things, like reading or playing with the dogs. His friends have learned to transfer him from his wheelchair to a car so they can take him to the movies or out to eat. When they recently took a trip to the beach, Julie said five of Jacks friends carried him out to the sand a lesson on how hard it is to navigate the world in a wheelchair.

Jack said he believes technology one day will advance enough that he wont be paralyzed forever. He also volunteered to do stem cell surgery to allow doctors to study the effects of stem cells on his spine for the next 15 years. Instead of wallowing in self-pity, hes moving forward. But hell need help.

Im appreciating everything in the now, he said.

Doctors have said Jack has adapted faster than expected, but there are still some everyday essential tasks that are out of his reach. He cannot write or cook. He can shower himself but cant dry himself or transfer himself in and out of his wheelchair. The Massey family hopes to secure a personal care attendant for Jack at school, but until then Julie will be in Gainesville to help him transition. An occupational therapy student from the university will also help Jack on a temporary basis.

Finding proper care for her son has proven to be a learning experience for Julie and her husband, Lance.

I dont know how people do it, she said. We have good health care, but then theres hidden costs. Theres travel expenses. Its kind of humbling. Nobody should have to go to GoFundMe for medical help.

Jack wants to spend his final year as an undergrad as independent as possible. After months of helping him recover, Julie said it will be hard to let her son go. Jack is the oldest of three; his brother Lance is 19 and a student at the University of Florida and his sister Alina is 14 and attends Ruckel Middle School.

Its like letting him go off to kindergarten again, she said.

As for life after college, Jack said he doesnt feel limited in career choices. One of his professors in the geology department encouraged him by saying that there were plenty of opportunities he could pursue in that field. Jack said he may also consider law school. One thing hes learned through this life-altering experience is that there are no limits to what he can achieve.

I havent done that much deep thinking. I just go with the flow, he said. But I learned I have more perseverance. Im more mentally tough than I thought I was. Im appreciative for life in general. Thats one of the big things.

Originally posted here:
Paralyzed After Pool Accident, Student Heads Back To College - News Talk Florida

(Reuters) - The U.S. Food and Drug Administration (FDA) is stepping up efforts to better regulate an emerging field of medicine that holds significant promise for curing some of the most troubling diseases by using the body's own cells.

A small number of "unscrupulous actors" have seized on the promise of regenerative medicine and stem cell therapies to mislead patients based on unproven, and in some cases, dangerously dubious products, the FDA said on Monday. (bit.ly/2iB4Xls)

Regenerative medicine makes use of human cells or tissues that are engineered or taken from donors. Health regulators have approved some types of stem cell transplants that mainly use blood and skin stem cells after clinical trials found they could treat certain types of cancer and grow skin grafts for burn victims.

But many potential therapies are still in the earliest stages of development. These therapies are sometimes advertised with the promise of a cure, but they often have scant evidence backing their efficacy or safety.

The FDA said it had taken steps to tackle the problem of some "troubling products" being marketed in Florida and California.

Federal officials on Friday seized from San Diego-based StemImmune Inc vials containing hundreds of doses of a vaccine reserved only for people at high risk for smallpox, the FDA said. (bit.ly/2wC1DMU)

The seizure followed recent FDA inspections that confirmed the vaccine was used to create an unapproved stem cell product, which was then given to cancer patients, the agency added.

The FDA also sent a warning letter to a Sunrise, Florida-based clinic for marketing stem cell products without regulatory approval and for major deviations from current good manufacturing practices. (bit.ly/2giGlx9)

The health regulator will present a new policy framework this fall that will more clearly detail the "rules of the road" for regenerative medicine, FDA Commissioner Scott Gottlieb, a cancer survivor, said in a statement.

Reporting by Natalie Grover in Bengaluru; Additional reporting by Tamara Mathias; Editing by Sai Sachin Ravikumar

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US FDA steps up scrutiny of stem cell therapies - Reuters

A SpaceX Falcon 9 rocket and Dragon cargo ship stand atop Pad 39A at NASA's Kennedy Space Center in Florida for the CRS-11 mission in June 2017. SpaceX will launch a new Dragon cargo ship to the International Space Station on the CRS-12 cargo mission for NASA on Aug. 14, 2017.

A SpaceX Falcon 9 rocket will launch the last brand-new Dragon cargo spacecraft to the International Space Station (ISS) Monday (Aug. 14), and you can watch all the action live online.

The Falcon 9 is slated to blast off from at 12:31 p.m. ET (1631 GMT) from Launch Complex 39A at NASA's Kennedy Space Center in Florida. About 10 minutes later, the rocket's first stage will separate and head back to Earth to stick an upright landing. You canwatch the launch live on Space.com here, courtesy of NASA TV's livestream. You can alsowatch SpaceX's own webcast here.

Monday's launch marks the 12th cargo resupply mission SpaceX has launched to the spacestation under the Commercial Resupply Services contract the company signed with NASA in 2008. Originally the contract called for only 12 launches, but SpaceX has since extended that agreement toinclude20 cargo missions. While this won't be the last cargo launch for SpaceX, it will be the last time the company launches a brand-new Dragon spacecraft. From now on, onlyreused Dragon spacecraftwill fly to the International Space Station, SpaceX representatives said Sunday (Aug. 13). [Gallery: Dragon, SpaceX's Private Spacecraft]

The Dragon will deliver more than 6,400 lbs. (2,900 kg) of science experiments, hardware and supplies for the Expeditions 52 and 53 crewmembers after a two-day trek through low-Earth orbit. On Wednesday (Aug. 16) at about 7 a.m. EDT (1100 GMT), NASA astronaut Jack Fischer will use the space station's robotic arm to grapple the spacecraft from inside the Cupola window. Canadarm2 will then install the Dragon on the bottom of the space station's Harmony module, where it will stay for about a month.

Opening of the hatch and unloading of the cargo isn't on the crew's schedule until Thursday, but the crew may try to get a head start to get their hands on some particularlydelicious frozen cargo ice cream. "I think the crew is aware that there are some frozen treats on this particular mission, so I wouldn't be surprised if they work long in the day and try to open the hatch and enjoy some," said Dan Hartman, deputy ISS Program manager at Johnson Space Center in Houston, at abriefing on Sunday (Aug. 13).

Supplies for the crew only make up a small portion (less than 8 percent) of the cargo packed inside the Dragon spacecraft. Nearly 75 percent of the cargo weight consists of science experiments that other equipment that will support dozens of research investigations conducted by the crews of Expeditions 52 and 53.

One notable biology experiment will researchnew treatments for Parkinson's diseaseby studying a key protein, LRRK2, in a microgravity environment. Another experiment will test strategies for growing lung tissue from stem cells, a bioengineering technique that could one day repair damaged organs and reduce organ rejection. Also aboard the Dragon will be 20 live mice, which will help scientists understand the physiological effects of long-duration spaceflight.

One investigation by the private company NanoRacks and sponsored by the U.S. Department of Defense aims to validate the concept of using microsatellites with imaging systems to support critical military operations. And outside the space station, an astrophysics observatory known as Cosmic Ray Energetics and Mass for the International Space Station (ISS-CREAM) will measure the charges of cosmic rays with a balloon-borne experiment.

Some young, aspiring scientists with Boy Scout Troop 209, based in Chicago, will also send an experiment into space on this Dragon launch. They will study how bacteria exposed to cancer-causing agents mutate in microgravity and on Earth. Their findings could have implications for future cancer research.

Because the ISS crew has a busy week ahead, SpaceX only has one shot to launch this Dragon. If Monday's launch is scrubbed, the next launch window will open no earlier than Saturday (Aug. 19), Hartman said, calling Monday's launch "a one-attempt."

Rescheduling the launch for Tuesday (Aug. 15) would put the Dragons arrival date at the same time as a Russian spacewalk on Aug. 17. Then on Aug. 18, NASA's Tracking and Data Relay Satellite will launch from Kennedy Space Center as well.

As of Sunday evening, the weather forecast is 70 percent favorable for launch. "Primary weather concerns will be cumulus clouds and flight through precipitation, although the early afternoon launch time is promising," NASA officials said.

Email Hanneke Weitering at hweitering@space.com or follow her @hannekescience. Follow us @Spacedotcom, Facebookand Google+. Original article on Space.com.

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