FDA Cracks Down on ‘Unscrupulous’ Stem Cell Clinics – New York Times

On Friday, the agency said, federal marshals seized 500 doses of live Vaccinia virus vaccine for smallpox belonging to StemImmune Inc., a San Diego firm that develops stem cell-based immunotherapies for cancer. The raid came after the F.D.A. learned that the vaccine was being used to create an unapproved stem cell product, a combination of excess amounts of vaccine and stem cells derived from body fat, which was then administered to cancer patients with potentially compromised immune systems.

The F.D.A. said patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif., received the treatment made with the smallpox vaccine. It also said it had serious concerns about how StemImmune obtained the vaccine for use in an unapproved and potentially dangerous treatment.

StemImmune obtained at least some of the vaccine from the Centers for Disease Control and Prevention, according to Thomas Skinner, a C.D.C. spokesman. In its request, the company said it was conducting cancer research involving the vaccinia virus, and needed to vaccinate researchers a seemingly legitimate reason. The company did not tell the C.D.C. that it was going to inject the vaccine into patients, he said.

A statement from StemImmune said the company had lawfully obtained the drug.

The F.D.A. also issued a warning letter to U.S. Stem Cell, a private clinic in Sunrise, Fla. The company was the subject of a March report in The New England Journal of Medicine, describing how one woman went blind and two others suffered severe, permanent eye damage after being given shots of stem cells, extracted from fat, into their eyes.

The warning letter accused the company of impairing the F.D.A.s ability to conduct its inspection by refusing to allow inspectors in, and denying them access to employees. It also said that U.S. Stem Cell had failed to establish proper quality control and sanitary standards.

In a statement Monday afternoon, U.S. Stem Cell denied ever restricting access to F.D.A. inspectors, or having sterility problems. 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, it said.

Noting that the F.D.A. has asked patients with concerns to come forward, the company said it had asked patients who have had positive experiences with their stem cell treatments to notify the agency.

But in the warning letter, the F.D.A. noted that U.S. Stem Cell had claimed its work was not subject to agency regulation. The F.D.A. disagreed, saying that the cells extracted by the company met the definition of both a drug and a biological product, both of which come under the agencys jurisdiction. In its statement, U.S. Stem Cell said it would abide by the new rules the agency is developing for the field.

Dr. Gottlieb said it was imperative to shut down fraudulent and unsafe players in the field in order to take advantage of the promise of stem cell therapies and to increase innovation in the regenerative medicine field, a program authorized by Congress in the 21st Century Cures Act.

Those enterprises put the entire field at risk, Dr. Gottlieb said. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.

The California Stem Cell Treatment Centers were founded in 2010 by Dr. Mark Berman, a plastic surgeon, and Dr. Elliot Lander, a urologist. Dr. Berman defended the company, and said that the F.D.A. had not accurately interpreted its cancer pilot study with StemImmune. Dr. Berman, who is also a director of StemImmune, also said that none of the patients had experienced serious adverse effects or died as a result of the treatment involving the vaccine, which he noted, was free.

Dr. Berman and Dr. Lander also train other physicians to perform liposuction, extract stem cells from the fat and inject the cells to treat many ailments, including heart disease, back and knee pain, asthma and neurological disorders.

After training, the physicians can become affiliates of the Cell Surgical Network, which has more than 60 members around the country. Patients are charged $8,900 per procedure, Dr. Berman said in a previous interview. He said affiliates purchase a centrifuge and incubator from the network for about $29,000, and pay the network $1,000 for the disposable liposuction equipment needed for each procedure.

A Florida woman, Doris Tyler, 77, lost her sight after being treated last September at an affiliate of the Cell Surgical Network, the Ageless Wellness Center in Peachtree City, Ga. Cells from her fat were injected into both eyes.

Before the treatment, Mrs. Tylers sight had deteriorated because of age-related macular degeneration. But she said she could still see well enough to get around, cook and read.

Within a month of the injections, Mrs. Tyler had a retinal detachment and lost the sight in her left eye. A few weeks later, the same thing happened to her right eye.

She consulted Dr. Thomas Albini, an eye surgeon at the Bascom-Palmer Eye Institute at the University of Miami, who had also examined the three women who went blind after similar treatment at the U.S. Stem Cell Clinic.

In an interview, Dr. Albini said Mrs. Tylers case resembled the others. The stem cells apparently formed a membrane that pulled the retina off the back of the eye, causing blindness. Attempts to reattach the retinas surgically could not restore Mrs. Tylers sight. She was permanently blinded.

Calls to the clinic in Peachtree City were not returned.

Dr. Berman said that because of her case, affiliates of the Cell Surgical Network were being advised to avoid giving injections directly into the eyes.

We made a bad decision to have this done, Mrs. Tylers husband said.

Dr. Gottlieb said the F.D.A. would soon publish documents detailing which new treatments and products are subject to agency regulation, and which are not, and giving details on a new, expedited path for companies with legitimate products, seeking premarket approval.

Some industry representatives applauded the move.

The F.D.A.s proposal is clear evidence of the fact that the regenerative medicine sector has matured and has moved from just a research sector to a development of market ready products, said Michael Werner, a partner in the law firm of Holland & Knight and the executive director of the Alliance for Regenerative Medicine. Hes clearly distinguishing unscrupulous actors who are playing upon hype and taking advantage of patients and product developers who are actually going to treat diseases.

He is trying to balance patient safety and a regulatory pathway that is as least burdensome as possible, Mr. Werner said.

Public health advocates praised the F.D.A. for moving against the companies, but said it should have happened sooner, given the widespread knowledge of public harm.

We certainly welcome this type of action, although it comes belatedly, said Dr. Michael Carome, director of Public Citizens Health Research Group. The agency has known about these unscrupulous actors for years.

Because of an editing error, an article on Tuesday about a Food and Drug Administration crackdown on stem cell clinics omitted comments from two of the companies cited StemImmune in San Diego and California Stem Cell Treatment Centers in Rancho Mirage, Calif., and Beverly Hills. It is not the case that the companies did not respond to requests for comment. The article reported that the F.D.A. had serious concerns about how StemImmune obtained hundreds of doses of small pox vaccine containing live Vaccinia virus for use in an unapproved and potentially dangerous stem cell treatment. A statement from StemImmune said the company had lawfully obtained the drug. The article also reported that patients at the California Stem Cell Treatment Centers received the treatment made with the smallpox vaccine. In response, Dr. Mark Berman, one of the founders of the centers, said that the F.D.A. had not accurately interpreted a cancer pilot study that the centers conducted with StemImmune. Dr. Berman, who is also a director of StemImmune, said that none of the patients had experienced serious adverse effects or died as a result of the treatment, which he noted was free.

A version of this article appears in print on August 29, 2017, on Page A17 of the New York edition with the headline: F.D.A. Cracks Down On Stem Cell Clinics It Calls Unscrupulous.

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FDA Cracks Down on 'Unscrupulous' Stem Cell Clinics - New York Times

Creative Medical Technology Holdings Achieves 100% Patient … – Markets Insider

PHOENIX, Aug. 28, 2017 /PRNewswire/ -- Creative Medical Technology Holdings Inc. (OTCQB ticker symbol CELZ) announced today completion of enrollment in the Company's clinical trial assessing safety and efficacy of its CaverstemTM procedure to treat erectile dysfunction in patients who do not respond to currently available treatments.Approximately 30% of the 30,000,000 patients suffering from erectile dysfunction do not respond to drugs like Viagra, Cialis and Levitra, in part due to an underlying degeneration of the biological machinery needed to achieve erections.

"The CaverstemTM procedure, which uses the patient's own bone marrow derived stem cells to induce arterial and venous regeneration, is an outpatient procedure able to be conducted by Urologists in their medical facilities. We are using a patient's own cells and we do not manipulate the stem cells through the use of chemicals, growth factors or expansion and have experienced no procedure-related safety issues," said Dr. Thomas Ichim Co-Founder and Chief Scientific Officer of Creative Medical Technology Holdings, Inc.

The clinical trial covering patients ages 18 to 80 received Institutional Review Board (IRB) approval in December 2016. The trial is sponsored by us based on our patented technology and is conducted by Dr. Jacob Rajfer, Principal Investigator and Los Angeles Biomedical Institute at Harbor UCLA Hospital in Torrance, CA.

"I am pleased with the expedience and efficiency at which enrollment was reached. As someone who regularly sees patients suffering from treatment non-responsive erectile dysfunction, I am excited to see the development of a novel approach to treating this condition using the patient's own natural regenerative processes," said Dr. Alexander Gershman, member of the Company's Scientific Advisory Board and Director of Institute of Advanced Urology at the Cedars-Sinai Medical Tower; Director of Urologic Laparoscopy in the Division of Urology, Harbor-UCLA Medical Center."

"We are very fortunate to work with the expert team at Los Angeles Biomedical Institute - UCLA/Harbor Hospital who have done an outstanding job with subject recruitment, screening, treatment and follow-up.We firmly believe that we are on schedule for commercialization of the Caverstem TM procedure through publication and presentation of trial results, marketing, licensing, training and sales in 2018," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings Inc.

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a clinical stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to http://www.creativemedicaltechnology.com. For more information on our CaverstemTM procedure please go to http://www.caverstem.com.

Forward-Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at http://www.sec.gov.

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BACK IN ACTION: Stem Cell Knee Procedure Gets Middle Aged Athlete Back On Slopes, Court – SpaceCoastDaily.com

REGENERATIVE MEDICINE STEM CELL THERAPY

DR. JOHN HERMANDORFER, above left, harvested cells from Giles Malones left tibia, and injected these into Malones left knee. As Giles Malone, above on the ski slopes of Utah in January, sprinted into his 50s, he began noticing that his knees were getting sore with his active lifestyle. Unfortunately, the years finally decided it was payback time for all that stress on his knees.

BREVARD COUNTY, FLORIDA As Giles Malone sprinted into his 50s, he began noticing that his knees werent keeping up with his active lifestyle.

Malone, a partner/owner with Maverick Multimedia and Brevard Productions, is an avid weekend make it weekday warrior who cant get enough of skiing, tennis and golf and working out at the gym.

The avid athlete played soccer for Bristol City youth in England and at the University of Louisiana.

He was an intergral part of the coaching staff with Florida Techs soccer team, which won two NCAA championships. Unfortunately, the years finally decided it was payback time for all that soccer on his knees.

My left knee would be sore after working out several days in a row, said Malone. I have lots of mileage on that knee.

Giles Malone, (#8) was an avid athlete playing soccer for Bristol City youth in England, Cocoa Beach High School and at the NCAA Div. 1 University of Louisiana. He helped coach Florida Techs soccer team to two NCAA championships. Unfortunately, the years finally decided it was payback time for all that stress on his knees.

His 85-year-old father has had both knees replaced, and his 61-year-old brother has gone through the procedure once. Malone wanted to stave off, or possibly nix altogether, the possibility of a knee replacement, so he turned to treatment that is less invasive and much more holistic.

Being familiar with the success stories from the many people who have received treatment from Dr. Hermansdorfer, I opted to go the route of stem cell therapy, said Malone. This could save my knees later in life.

Malone was also impressed that Dr. John Hermansdorfer, who has a well-deserved reputation of excellence in traditional orthopedic procedures, would be handling his case.

The fact that these physicians with stellar reputations believe in stem cell therapy, tells me that this is a really viable option, said Malone.

Hermansdorfer has done extensive research on regenerative medicine.

Hermansdorfer, a 1982 graduate of the University of Kentucky Medical School, completed his residency in orthopedic surgery at the University of Florida and received fellowship training in hand surgery at the Indiana Center for Surgery and Rehabilitation of the Hand in Indianapolis.

DR. JOHN HERMANSDORFERs treatment was performed in conjunction with a knee arthroscopy, a surgical procedure that allows doctors to treat the joint without the need for a large incision. Hermansdorfer debrided damaged cartilage from the patients knee using miniature surgical instruments, at left, inserted through an arthroscope, an instrument about the diameter of a soda straw and fitted with a miniature camera, a light source and precision instruments at the end of flexible tubes.

HIGH OCTANE AMNION CELLS

Recently, Malone underwent the elective procedure, which harvested cells from his tibia, and injected these into his knee.

The treatment was performed in conjunction with a knee arthroscopy, a surgical procedure that allows doctors to treat the joint without the need for a large incision.

Hermansdorfer debrided damaged cartilage from Malones knee using miniature surgical instruments inserted through an arthroscope, an instrument about the diameter of a soda straw and fitted with a miniature camera, a light source and precision instruments at the end of flexible tubes.

It was not just one procedure, but a combination of procedures to obtain optimal results, said Hermansdorfer.

Malone was the perfect candidate for the stem cell procedure in strong physical condition, with the knee in solid shape just lots of mileage.

He is the typical middle-aged athlete, said Hermansdorfer. When they get older, these individuals start to pay the price.

Before the advent of stem cell therapy, options for Malone would have been minimal.

This is a much better option than pills or cortisone shots, which can have a damaging effect over time, said Hermansdorfer.

Malone is not alone in his pain. Joint and spinal pain are a common complaint, and invasive surgery for these issues requires significant downtime with true success often elusive.

BioCellular Therapies regenerative cell treatment, on the other hand, is a kinder, gentler and definitely viable alternative for individuals suffering from osteoarthritis, degenerative disc disease or sports injuries.

Regenerative cells repair muscle, tendon, ligament and cartilage and they do it quickly.

There is no question it works, said Hermansdorfer. Research shows good results. It enhances cartilage growth, which allows us to move our joints without pain.

Interest in this type of treatment is so high that individuals from outside the United States have scheduled treatment with BioCellular Therapies, located in Melbourne.

We have had patients from their teens to their 80s, said Hermansdorfer. Its so simple, its so safe.

However, not everyone is an appropriate a candidate as Malone was.

Age of the patient is not an issue, but rather the severity of the problem, said

Hermansdorfer, recounting an 80-plus-year-old patient who was also a perfect candidate because the cartilage in her knee had not yet been worn down beyond repair.

We have to have a reasonable amount of cartilage left.

SPACE COAST DAILY TV MEDICAL SEMINAR SERIES:Dr. Mark Pinsky and Jim Eaker,experts at BioCellular Therapies in Melbourne, Florida, talk with Giles Malone about the revolution in contouring and tightening your face, neck and body; and body rejuvenation, including the Vampire Facelift and Breastlift, and the O-Shot.The pursuit of youth and beauty has become an easier journey along the Space Coast with the introduction recentlyby BioCellular Therapies of the Vivace RF microneedling system, used in conjunction with amnion-based gels and creams for optimum performance in promoting the development of collagen for easing fine lines, wrinkles and uneven skin.

RAPID RECOVERY, LITTLE PAIN

For the arthroscopy and stem cell therapy, Malone arrived at Atlantic Orthopedic Surgery at 9 a.m. By noon, he was home. Afterwards, he needed no pain killers other than Tylenol. Although he used a cane for a couple of days, he soon ditched it.

There was little down time, he said.

Because of the arthroscopy component, Malone opted for general anesthesia, but stem cell treatments can be performed in an office setting under a local block.

Six weeks after the procedure, Malone should be back to participating in the sports he loves. The two small incisions required for the arthroscopy already are now invisible. Another of Hermansdorfers patients, a marathon runner, returned to marathons six weeks after receiving the stem cells.

Compare Malones experience with that of a patient undergoing knee replacement surgery. The individual is expected to be on crutches for six weeks. Pain can be significant, too.

Not only is downtime for stem cell therapy almost non-existent, but it is also a quick and painless endeavor. Harvesting and mixing the cells requires minimal time.

It just takes five minutes, said Hermansdorfer.

The cells are reinserted into the patients body through micro-fracturing.

They do tiny holes in the bone so it better accepts the stem cells, explained Malone. I compare it to turning up the soil to better grow plants.

Using the super cells found in the patients own bone marrow optimizes healing and reduces risk. This is so much more natural medicine, said Hermansdorfer.

BioCellular Therapies is at 2290 W. Eau Gallie Blvd., Suite 210, Melbourne. For more information on the practices hair restoration services, call 321-435-1505 or visit BiocellularTherapies.com

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BACK IN ACTION: Stem Cell Knee Procedure Gets Middle Aged Athlete Back On Slopes, Court - SpaceCoastDaily.com

Bait and Switch – Stem Cell Treatments and Insurance …

I was astonished when I saw a press release from a new medical provider in California that trumpeted their orthopedic stem cell and platelet procedures were covered by Medicare and most PPO insurance companies. To the best of my knowledge, all platelet and stem cell procedures done on an outpatient basis are not covered by any health insurance company, and especially not by Medicare. So I went back to my billing folks and asked them if anything had changed regarding coverage for the procedures. When they said no, I then researched it myself to be certain that my people were giving me accurate information, which re-affirmed that my assumptions were true.

So, being the curious guy I am, I called the operation who was advertising on the web and in the press release and was told that the procedure was in fact covered by many insurance companies, however they could only confirm coverage after reviewing the benefits of my plan. I explained that I had Medicare with a supplemental and was told that they would have to look into the coverage details of my secondary supplemental benefits. In any case, I would have to pay out of pocket for the kit that would be used for the marrow draw to obtain my stem cells, but the actual injection may be covered. The young lady suggested that I make an appointment for a consultation with the doctor and they would then advise me what was covered and what was not.

It is apparent to me that either this operation is billing fraudulently or is running a bait and switch with patients. The old used car sales philosophy of get them in the door and we will get as much as we can from the client seems to be their method of operation. This is very upsetting to me as we have had several candidates wanting to undergo our procedures insist that it was covered by their insurance.

I want to assure our patients that we will accurately and ethically bill Medicare and other insurance carriers for all procedures that are covered by their policies. We also continuously monitor all changes, especially of procedures that are currently considered experimental or investigational and are not covered. It is unfortunate that some physicians participate in insurance fraud as it reflects poorly on the entire medical profession. Health Link Medical Center and Regenexx maintains the highest standard of patient care and integrity. We are here to serve our patients with the worlds most advanced biological cellular therapies for orthopedic conditions.

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Bait and Switch - Stem Cell Treatments and Insurance ...

2 patients contract Legionnaires’ Disease at UW Medical Center – KING5.com

Two people contracted a serious type of pneumonia while being treated at UW Medical Center. One of them, a woman in her 20's, died this morning, though health officials say she also had underlying conditions.

Travis Pittman and Heather Graf, KING 12:47 AM. PDT August 26, 2017

Two people contracted Legionnaires' disease at University of Washington Medical Center, King County Public Health announced Friday. One of them died, but officials say it's too early to tell if Legionnaires' was the cause of death.

A man his 40s was reported to have Legionnaires' on Wednesday and is now in the process of being discharged.

A woman in her 20s was reported to have the disease on Thursday and died Friday morning. King County Public Health said the woman was very ill, had multiple underlying conditions. It's not yet known if Legionnaires was a cause of death.

A third UWMC patient, a man his 60s, was also reported on Thursday to have Legionella pneumonia. It's believed he acquired it outside of the hospital.

King County Public Health says there's no evidence to suggest the public is at risk. The department is investigating to see if other patients were affected and the possible source of the infection.

But that's doing little to ease the concerns of patients and their families.

"It's very scary. I'm frightened that I have to keep my child here. But I don't have an option to bring him home, because he's too sick. They need to be a little more urgent in protecting him," said Tammee Ryan.

Ryan's 22-year-old son is a UWMC patient. She says he went through chemotherapy first, followed by a stem cell transplant that left him with a weakened immune system. That's why's she's so worried about Legionnaires'.

"The patients on his floor in the Cascade Tower are very susceptible to any type of illness, due to the fact that they're getting chemo to suppress their immune systems," she said. "He's susceptible to anything."It's a concern the staff atUWMC knows all too well.

After five people were confirmed to have Legionnaire's Disease at the hospital last year, UW Medical Center said it began a "robust Water Management Plan" to prevent future cases. UWMC says, as of July, water samples tested at the hospital did not show any issues in the water system related to Legionella bacteria.

*Installing special water filters in the Cascade Tower, where the patients were being treated

*Temporarily limiting water use on all inpatient units of the Cascade Tower until the filters are installed

*Performing environmental tests

*Additional monitoring and testing of patients

Hospital staff said 150 water filters were installed on Friday in rooms belonging to high-risk patients. More filters are expected to be installed over the weekend.

The CDC says Legionella is found naturally in freshwater environments, like lakes and streams, but it can grow and spread in man-made water systems including hot water tanks and heaters, large plumbing systems, cooling towers used for air conditioning in large buildings, and decorative fountains.

Health officials say one of the biggest challenges is that the bacteria can be difficult to eradicate from water systems.

Symptoms of Legionnaires disease include

*Cough

*Shortness of breath

*Fever

*Muscle aches

*Headaches

2017 KING-TV

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2 patients contract Legionnaires' Disease at UW Medical Center - KING5.com

Twin Falls multiple sclerosis patients are traveling to get new treatment – Coeur d’Alene Press

TWIN FALLS Over 30 years, Judy Fisher has been left with very few options for treating her multiple sclerosis.

But for the Twin Falls resident, who has the primary progressive form of the disease, theres finally an approved medication she can try.

The Food and Drug Administration approved Ocrevus in March after a large study found it slowed progression of the neurological disease and reduced symptoms. Its approved for both patients who have relapsing and primary progressive forms of MS.

This medicine is really promising, Fisher said.

Its the first FDA-approved medication shown to be effective in treating primary progressive MS. But for months, Magic Valley residents whove wanted to try the new treatment which is delivered intravenously have been forced to travel elsewhere.

Every time theres a new drug on the market, health systems decide whether to add it to its formulary, and that determines whether it will be available to patients.

Dr. John Steffens, a neurologist at St. Lukes Magic Valley Medical Center, told the Times-News on Thursday he received confirmation Ocrevus will be offered at St. Lukes infusion centers soon.

He has about a dozen MS patients who are receiving the new treatment. Most of them have primary progressive MS, but a few have relapsing form of the disease and havent seen results with other medications.

Theyve been traveling to other health care facilities such as Cassia Regional Hospital, Saint Alphonsus Regional Medical Center in Boise, Portneuf Medical Center in Pocatello and University of Utah Hospital in Salt Lake City.

Since 1993, 14 drugs have been approved to slow the most common form of MS, but everything tested against primary progressive MS failed until now. An estimated 15 percent of MS patients have the primary progressive form of the disease, Steffens said.

In primary progressive MS, the diseases course varies among patients, but symptoms gradually worsen from the start and there usually are no periods when symptoms subside.

Symptoms are caused by the immune system attacking the fatty coverings on nerves in the brain and spinal cord that protect them, much like insulation on electrical wiring.

As the coverings deteriorate, nerve messages arent properly transmitted, disrupting movement and muscle control.

For years for people who have primary progressive MS, doctors were left to treat symptoms and cross their fingers hoping a new medication would be developed, Steffens said.

Hed also have patients try other MS medications to see if theyd work, but they often didnt.

Fisher was diagnosed with MS in 1988 when she was in her 30s. Now shes 63.

Ive been lucky, she said. I havent progressed fast at all.

The only prescription medication shes taking is a water pill. Weakness in her right side due to MS, she said, hasnt gotten much worse over the years.

Seven years ago, she underwent stem cell treatment in Germany and saw excellent results. For three months, I was darn near perfect, Fisher said. Im still reaping the benefits from it.

But many of the symptoms have returned, she said. I would give anything to do stem cell again, but its too expensive.

At an appointment with Steffens her neurologist a couple of months ago, Fisher expressed interest in Ocrevus.

But it just came out, Fisher said. He said he had like three or four patients now doing it. I am waiting to see what goes on with them.

Will she try Ocrevus? If theres any way I can afford it, you bet I am, Fisher said. Her next neurology appointment isnt until November.

Active in the local MS community, especially with fundraising walks, Fisher said theres a lot she doesnt know about Ocrevus, but she has read about it.

This is big for that type of MS, she said. It has helped even mobility on people and that is what I would be looking for.

Compared to study participants getting dummy infusions, patients given Ocrevus infusions had slower declines in walking ability and slower disability progression over nearly 2 years.

The Ocrevus group also had fewer new brain-damaging lesions develop but slightly higher rates of certain side effects, including upper respiratory tract infections and tumors developing in various parts of the body.

Ocrevus is given intravenously every six months. It takes about half a day to receive treatment, Steffens said. Its a really logistically simple drug to give.

The medication also seems to be well tolerated among patients, he said, and has the fewest side effect warnings among any MS drugs he has encountered.

During a recent follow-up appointment with Steffens first patient who has received treatment, the person is walking better now than in three years, he said.

But he doesnt know if thats a placebo effect or if that will be a sustained benefit.

And the bad news for MS patients, Steffens said: We still have no cure for any form of the disease.

One common dilemma for MS patients can be figuring out how to pay for often-costly treatment.

Ocrevus was developed by Genentech, part of Swiss drugmaker the Roche Group. Genentech, based in South San Francisco, Calif., has said the initial list price without insurance is $65,000 a year.

So far, Steffens hasnt heard of any of his patients having problems getting the treatment covered by insurance.

And with patient assistance programs factored in, too, co-pays are typically less than $100, he said.

We were expecting huge, huge pushback from insurance companies, he said, but that hasnt been the case.

After years of waiting, it means more local MS patients may be able to finally get the help theyve been looking for.

The Associated Press contributed to this report.

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Twin Falls multiple sclerosis patients are traveling to get new treatment - Coeur d'Alene Press

As Blumen fights cancer, city creates awareness on stem cell donation – Times of India

Chennai has always been upfront when it's about coming together for a good cause. And we've witnessed that many a time in the recent past. Now, its heart beats for Blumen Rajan Sathya, a 27-year-old from Chennai, who's fighting blood cancer and awaiting a stem cell donor. His friends from school and college have come together to put up a signature campaign for this youngster and also raise awareness about stem cell donation, at Grand Mall (Velachery) on Saturday and Sunday. "Thanks to Blumen's friends this was planned only on Wednesday night and they've put together everything in just a matter of two days. Blumen had been quite popular in school and college for he was a state-level athlete, a guitarist, and he made friends with lot of people who're now in different fields, including film and music industry, medicine, media, etc. Now, they're all coming together to support the cause," shares Carolyn Pinky, Blumen's elder sister. Giving more details about the campaign, Carolyn, says, "The main idea behind this signature campaign is to create awareness on cancer and stem cell donation. In fact, there are many people talking about stem cell donation and how it's done during the campaign. As for the funds for his treatment, we are providing a barcode which those interested can use to contribute to the fund. His treatment costs roughly around `40 lakh. And till now, we've already collected `37 lakh." Reiterating the importance of creating awareness on stem cell donation, Dr Girish Subash, who's a close friend of Blumen, says, "Stem cell donation can be done only when the donor is alive, kicking and well, unlike other donations. It's a slightly complicated process, but not harmful in any way to the donor. The awareness we need to create is that stem cell donation is not painful, dangerous or scary. In Blumen's case also, though they are thousands of people coming forward to help him in terms of funds, the number of people who actually came to get the test done for stem cell donation is less. How it's done is that you put cannulas on both hands of the donor and his blood goes through a machine and comes back to the person. It's like an additional loop in the existing blood vessel circuit. And the machine will cultivate the stem cells from the blood directly." Another childhood friend of Blumen, Abishek Rengasamy, says, "We've managed to collect this much money in just a week's time. I am sure we will be able to raise the balance `three lakh in the next two days. So, the idea behind this signature campaign is not to collect money, but create awareness on blood cancer and stem cell donation. I am confident that Blumen will be back completely recovered after the treatment. So, before he left for Tata Medical Center, Kolkata, where he's admitted now, I asked him what he wanted to do after coming back, he said 'I want to completely work for cancer fighters'. So, we don't want to stop this with just helping Blumen, but continue helping others who are needy." Meanwhile, Carolyn says that they are still looking for a donor for Blumen. "We've already had a camp in Chennai looking for donors. Around 200 people gave blood samples. Unfortunately, we couldn't find a perfect match out of that. Only one in a lakh will match with the patient's stem cells. Now, we're waiting to hear from Kolkata. They've found one person from Mumbai whose blood sample also matches with that of Bluman's," shares Carolyn.

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As Blumen fights cancer, city creates awareness on stem cell donation - Times of India

Mayo, U develop ‘robocop’ stem cells to fight cancer – StarTribune.com – Minneapolis Star Tribune

Glen Stubbe - Star Tribune The Mayo Clinic expects a surge of hundreds of cancer patients per year if CAR T is approved, because it will initially be provided by large medical centers that have experience with the therapy and its side effects.

Researchers at the Mayo Clinic and the University of Minnesota say theyre on the brink of a new era in cancer care one in which doctors extract a patients white blood cells, have them genetically engineered in a lab, and put them back to become personalized cancer-fighting machines.

The so-called CAR T cellular therapies are expected to receive federal approval this fall for certain rare blood cancers B-cell forms of lymphoma and leukemia. But scientists at the Minnesota institutions hope thats just the first step that will lead to better treatment of solid tumor cancers as well.

This is really the first approval of a genetically modified product for cancer therapy, said Dr. Jeffrey Miller, deputy director of the Masonic Cancer Center at the University of Minnesota. If the proof of concept works, he said, we might be on the right track to get away from all of that toxic chemotherapy that people hate.

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Mayo, U develop 'robocop' stem cells to fight cancer - StarTribune.com - Minneapolis Star Tribune

Scientists Discover New Hair Growth Technique Using Stem Cells – TrendinTech

Those suffering from hair loss problems could soon be worry free thanks to a bunch of researchers at UCLA. The team found that by activating the stem cells in the hair follicles they could make it grow. This type of research couldnt come soon enough for some. We may have finally found a cure for patients suffering from alopecia or baldness.

Hair loss is often caused by the hair follicle stem cells inability to activate and induce a new hair growth cycle. In doing the study, researchers Heather Christofk and William Lowry, of Eli Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UCLA discovered that the metabolism of hair follicle stem cells is far different to any other cell found within the skin. They found that as hair follicle stem cells absorb the glucose from the bloodstream they use it to produce a metabolite called pyruvate. The pyruvate is then either sent to the cells mitochondria to be converted back into energy or is converted into another metabolite called lactate.

Christofk is an associate professor of biological chemistry and molecular and medical pharmacology and he says, Our observations about hair follicle stem cell metabolism prompted us to examine whether genetically diminishing the entry of pyruvate into the mitochondria would force hair follicle stem cells to make more lactate and if that would activate the cells and grow hair more quickly. First, the team demonstrated how blocking the lactate production in mice prevented the hair follicle stem cells from activating. Then, with the help of colleagues at the Rutter lab at the University of Utah, they increased the lactate production in the mice and as a result saw an accelerated hair follicle stem cell activation and therefore an increase in the hair cycle.

Once we saw how altering lactate production in the mice influenced hair growth, it led us to look for potential drugs that could be applied to the skin and have the same effect, confirms Lowry, a professor of molecular, cell and developmental biology. During the study, the team found two drugs in particular that influenced hair follicle stem cells to promote lactate production when applied to the skin of mice. The first is called RCGD423. This drug is responsible for allowing the transmission of information from outside the cell right to the heart of it in the nucleus by activating the cellular signaling pathway called JAK-Stat. The results from the study did, in fact, prove that JAK-Stat activation will lead to an increased production of lactate which will enhance hair growth. UK5099 was the second drug in question, and its role was to block the pyruvate from entering the mitochondria, forcing the production of lactate and accelerating hair growth as a result.

The study brings with it some very promising results. To be able to solve a problem that affects millions of people worldwide by using drugs to stimulate hair growth is brilliant. At the moment there is a provisional patent application thats been filed in respect of using RCGD423 in the promotion of hair growth and a separate provisional patent in place for the use of UK5099 for the same purpose. The drugs have not yet been tested in humans or approved by the Food and Drug Administration as fit for human consumption.

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Scientists Discover New Hair Growth Technique Using Stem Cells - TrendinTech

Could Newborn Heart Stem Cells Jump-Start Old Hearts? – Sioux City Journal

TUESDAY, Aug. 15, 2017 (HealthDay News) -- Stem cells from young hearts might breathe new life into aging ones, research in rats suggests.

In the study, a special type of stem cells was taken from the hearts of newborn rats and injected into the hearts of old rats, average age 22 months. Other rats from the same age group were given saline shots instead.

Baseline heart function was measured in all the rats, using echocardiograms, treadmill stress tests and blood analysis. The group of older rats underwent an additional round of testing one month after receiving the stem cells from the hearts of the young rats.

The old rats who were given stem cells showed better heart function, a 20 percent increase in exercise capacity and, oddly enough, an improved ability to regrow hair.

"Our previous lab studies and human clinical trials have shown promise in treating heart failure using cardiac [heart] stem cell infusions," said co-primary investigator Dr. Eduardo Marban, director of the Cedars-Sinai Medical Center Heart Institute in Los Angeles.

"Now we find that these specialized stem cells could turn out to reverse problems associated with aging of the heart," he said in an institute news release.

"The way the cells work to reverse aging is fascinating," Marban added. "They secrete tiny vesicles that are chock-full of signaling molecules such as RNA and proteins. The vesicles from young cells appear to contain all the needed instructions to turn back the clock."

But more research is needed, the investigators said.

"This study didn't measure whether receiving the [specialized] cells extended life spans, so we have a lot more work to do," added co-primary investigator Dr. Lilian Grigorian-Shamagian. She is a postdoctoral researcher at Cedars-Sinai.

"We have much to study, including whether [heart stem cells] need to come from a young donor to have the same rejuvenating effects," Grigorian-Shamagian explained.

The findings were published Aug. 14 in the European Heart Journal.

The U.S. National Heart, Lung, and Blood Institute offers a guide to a healthy heart.

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Could Newborn Heart Stem Cells Jump-Start Old Hearts? - Sioux City Journal