Within the Darkest Hollows by DA Roach @EJBookPromo @daroach12books

Title: Within the Darkest Hollows Series: Demon Hunters #2 Author: D.A. Roach Genre: YA Paranormal Release Date: December 13, 2016 Publisher: Limitless Publishing Cassidy and her mystical ring are …

Source: Within the Darkest Hollows by DA Roach @EJBookPromo @daroach12books

Patients Fight For Right To Their Own Stem Cells

Written by:

Jennifer Ziegler, Tracy Thompson and SammyJo Wilkinson

MARCH 15, 2016

What do you do when you have a chronic disease that has no known cure, and eventually, your doctor tells you there is nothing left to treat you with. Many Americans find themselves exactly in this position. You either put your affairs in order or you start looking for an alternative. Social media has been a lifeline for people with incurable diseases who have run out of medical options in the U.S. and are forced to turn to medical tourism. Since 2007, sites like Stem Cell Pioneers have provided patients a place to share information on treatment results and reliable clinics, as well as warnings about questionable operations.

In 2012, the FDA ruled that our own stem cells are considered a drug once they’re expanded in the lab to a therapeutic dose. This cut many of us off in the middle of treatment in Houston, Texas. To better understand why and when the FDA took control over the cells in your body, visit Patients For Stem Cells (PFSC) at www.patientsforstemcells.org or watch this short video they created.

Patients For Stem Cells came together as a spontaneous collective effort by patients who saw this FDA ruling of cells equating to drugs as a regulatory overreach. Once our own lives were saved or improved, we could not in good conscience resume daily living knowing our friends were still suffering with diseases that could benefit from cellular therapy. Our first blog posts challenged the reporters that repeated the story that all stem cell therapy is “snake oil.” We showed the media that the experts they relied upon had conflicts of interest in cellular therapies, for which they held patents, and hoped for royalty incomes from embryonic or induced pluripotent stem cells (iPSC). Your own adult stem cells cannot be patented or sold commercially. By speaking up, we were contacted by reporters of Business Week, NPR and other publications.

Outside the U.S., particularly in Asia, the use of high dose adult mesenchymal stem cells (MSCs) is in full swing for treating all kinds of degenerative diseases that have no other therapy options. Countries like Japan, Israel, Jordan, Mexico, Germany, Russia and Canada are leading the way in adult stem cell treatments, while the U.S. lags behind with its glacially slow regulation process. This approach has already been found to be safe in published trials and over 2,000 human subjects.

No treatment has shown reversal of established disability until now” -Dr. Saud A. Sadiq, M.D., FAAN

An important thing to understand is the difference between a same-day cell procedure and an expanded cell procedure. Many patients with orthopedic conditions can be treated with same-day cellular therapies. A bone marrow aspirate is often extracted from the patient. This differs from a bone marrow extraction, usually associated with pain. The cells are then processed in a lab and re-introduced back into the patient’s body that day in the area in need of repair. Other chronic illnesses, like multiple sclerosis, rheumatoid arthritis, cardiac disease and Parkinson’s, can be treated with expanded cells. Many of us at PFSC have been treated with expanded cells. These cells are also processed in a lab, but unlike same-day cell procedures, their numbers are increased by the hundreds of millions and then re-introduced into the patient at a later date through injection or IV. It can take several weeks or months to grow the cells to the therapeutic dose needed.

Tracy Thompson, one of our PFSC founding members, was an early pioneer of receiving stem cell therapy in another country. Tracy was at the point in her MS diagnosis where all FDA approved drugs had failed her. She found herself left as a “no option patient.” Not wanting to accept the status quo, she began researching adult stem cell therapy. Tracy, as many patients do, put a lot of time and effort into research to make an informed and intelligent decision about the cell therapy she was going to receive. She talked to her doctors and connected with other patients who had already undergone cell therapy. In 2008, she flew down to Costa Rica to receive her first stem cell treatment, from which she received many quality of life improvements. Upon returning home, her local neurologist refused to treat her any longer. She was told she was a “rogue patient” and kicked out of the practice. She offered to sign any legal waiver to credit or discredit the treatment she received and have it be used as a research tool for future patients. At the time, she was in her early 30s with two small children. This experience opened her eyes for the incredible need to help no-option, chronically ill patients have alternative options and a voice.

A united front from interested parties is the only way this is ever going to happen”

As a patient with a chronic disease, it’s not unusual to think about becoming a medical tourist seeking adult stem cell treatment in another country. Here is an excerpt from an article published in Dr. Camillo Ricordi’s CellR4 medical journal, “When No Option Is An Unacceptable Option,” written by PFSC member Jennifer Ziegler:

“I keep asking myself, why are so many MS patients seeking overseas, alternative treatments? MS patients in particular seem to be at the top of the list of “disease communities” seeking treatment abroad. There has to be more to this than meets the eye. The claims the drug companies, the FDA, and many scientists are making are in direct opposition to what MS patients are actually experiencing. I hope to dispel the idea that the majority of MS patients are being marketed to by foreign stem cell clinics. In reality, patients share their successes and failures in regard to adult stem cell treatments and clinics online. We then make informed decisions on becoming medical tourists. The successes we are seeing and hearing from other patients far exceed those derived from any FDA approved treatment available to us in the United States to date. You could then form a hypothesis about other “disease communities,” like ALS, Alzheimer’s, Parkinson’s, COPD, etc., seeking overseas treatment for exactly the same reasons. There is a giant breakdown in our current regulatory system, and the huge popularity of medical tourism is a direct reflection of this gaping black hole in domestic treatment options.”

There are big problems for many patients in becoming a medical tourist. First, many patients are too sick to travel, and second, it’s very expensive. That’s why PFSC is committed to helping patients seek safe and effective cellular therapy covered by insurance, right here in our own country. There are university clinical trials going on right now. If a phase one clinical trial proves to be safe and effective, then we feel access should be granted to patients who’ve exhausted all other FDA approved options. One of the success stories we recently heard about is a clinical trial for MS, reported on by MS patient Marc Steckler, also known as Wheelchair Kamikaze online. In this exclusive interview Dr. Sadiq tells Marc the Tisch MS Research Center has raised $3 million dollars and received approval for the next phase II trial of adult stem cells for secondary and primary progressive multiple sclerosis. “No treatment has shown reversal of established disability until now,” Dr. Sadiq said of the initial trial, adding the next phases will determine how much repair can be achieved.

We at Patients For Stem Cells have taken it upon ourselves to draw attention to as many positive adult stem cell patient stories as we can. This helps educate the public that the cells coming from your own body have the capability to heal. Same-day cell procedures in this country are in jeopardy of being shut down. Another patient success story is from collegiate volleyball player Brittany Wolf who underwent seven knee surgeries and a series of infections before she undergoing stem cell therapy to save the function of her knee.

SammyJo Wilkinson is a stellar example of a chronically ill patient who at 47-years-old was looking at nursing homes because her disease progression had gotten to the point where her husband Doug was no longer able to care for her in their home. Can you imagine a nursing home at 47-years-old? We’re happy to say SammyJo has had many quality of life improvements by being treated with her own cells.

Our mission at PFSC is to create awareness about the violation of our basic human rights to access our own stem cellsfor potential life-saving therapies. If you are a doctor or a patient interested in joining forces with us contact PFSC. A united front from interested parties is the only way this is ever going to happen.


For more information visit www.patientsforstemcells.org. You can also find Patients For Stem Cells on Facebook and Twitter.

Cellular Therapies to the Rescue?

This article was written for texasmontly.com by Sammy Jo Wilkinson of the Patient Advisory Board for the Alliance for the Advancement of Cellular Therapies (AACT) and can be reached at info@aact.com.

A recent Washington Post op/ed calls the 21st Century Cures Act—a bill that aims to accelerate the discovery, development, and delivery of life-saving and improving therapies—a “harmful step backward.” I respectfully disagree.

Cellular therapies are ideal to quickly turn the promise of the Act into real cures. UCLA just announced a regenerative medicine cure for Severe Combined Immunodeficiency (SCID), also called “bubble baby” disease, by combining gene and cellular therapy. Twenty-three children have recovered from SCID, and doctors are working with the FDA to speed nationwide trials. The 21st Century Cures Act supports this kind of acceleration.

Regenerative medicine deserves priority under the Act. Early adult stem cell trials consistently report safety without the higher risk profile of early stage drugs.

I agree with the authors of the op/ed about drug risk and their point about lack of precision medicine, tailoring the therapy to age and gender. Precision and safety might be further ignored due to shortened trials, but even approved drugs fail us. Allen Roses, CEO of GlaxoSmithKline, famously admitted more than 90 percent of drugs only work in 30 to 50 percent of people. Not yet covered by insurance, cellular therapy is proving a safer option than drugs for many orthopedic conditions, and the fact that patients are paying out of pocket indicates dissatisfaction with current practices.

My own recovery story shows what cellular therapy can do. Twenty years ago, the incurable disease of multiple sclerosis (MS) stole the lovely life I was enjoying with my husband. I was a 30-year-old CEO breaking ground in the nascent Internet industry. But the disease was aggressive, and I was disabled within seven years, ending my career. I tried each newly approved MS drug, but none stopped progression, most had harsh side effects and offered no symptom relief. By 2011, I was in a wheelchair with 28 symptoms of various miseries. With paralysis taking over, a nursing home looked like my next stop.

Hope emerged when I heard about a biotechnology company in Houston initiating breakthroughs in regenerative medicine using one’s own adult stem cells. The company, Celltex Therapeutics, extracts and isolates adult mesenchymal stem cells (MSCs) from a sample of fat taken from the abdominal region and offers lifetime cell banking. When therapy is needed, the pure MSCs are expanded in their lab to a therapeutic dose, similar to university clinical trials.

My first treatment in 2012 yielded immediate relief. But the FDA stepped in and blocked access to using one’s own stem cells in September 2012, based on their determination that expanded cells are a drug, subject to years of trials before approval. This delayed my therapy plan, until Celltex found a top-notch, certified hospital in Cancun, Mexico. Under regulations established by the FDA and COFEPRIS, Mexico’s equivalent of the FDA, I was able to resume treatment.

After four treatments over two and a half years, I’ve been in remission since May 2014. I feel good again, with 18 symptoms gone and the rest improved. I no longer need assistance to get in and out of bed, or down on the floor for yoga. I can even take short walks holding a railing for support. But my delight is shadowed by the suffering of so many patients I know who can’t access this therapy yet.

The op/ed authors criticize stories like mine as anecdotes, but for MS, we’ve already passed safety trials. At the 2014 annual neurology presentations a headline read “Stem Cell Therapyin MS Looks Safe; Test of Efficacy Awaits Future Trials.”

Legislators crafted the Cures Act, in response to the plight of patients who have run out of options. Further support is expressed by approval of “Right to Try” laws sweeping the U.S. The will is there, next comes implementation.

Patients, caregivers, doctors, researchers, regulators, investors, and insurers all need to work together to bring regenerative medicine into approved medical practice. The 21st Century Cures Act is a good framework and already on a swift passage through Congress.

Dr. Andrew von Eschenbach, former FDA director, has gone on record to state that, “Breakthrough technologies deserve a breakthrough in the way the FDA evaluates them. Take regenerative medicine… after proof of concept and safety testing, a product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies.”

Japan has adopted a Regenerative Medicine Act based on this concept, and it even includes early insurance coverage once safety is established. It is time for the U.S. to catch up.

Sa Woman Fights to Legalize Treatment She Says Is Saving Her Life

After years of MS symptoms, Stefanie Cowley found alternative treatment

By Courtney Friedman – VJ, Reporter

SAN ANTONIO – The stem cell therapy a San Antonio mother says is saving her life has been deemed illegal. Now, she and thousands of others across the nation are fighting to change that.

Stefanie Cowley rolled in her wheelchair as her 6-year-old son Tyler skipped beside her on the sidewalk, and she breathed it all in. She takes nothing for granted.

“Getting our vitamin D!” she laughed. “Sunshine!”

She was diagnosed with multiple sclerosis in 2007, and things went downhill quickly. MS is a disease in which the immune system eats away at the protective covering of nerves. It can cause vision loss, pain, fatigue and impaired coordination.

Two years ago, Cowley was bedridden and almost completely immobile.

“I was at rock bottom. I would rather not wake up the next day,” Cowley said.

For the five years after her diagnosis, she tried about six conventional and approved therapies, but none worked. She was only getting worse.

“At that point, I felt I was out of options. I was spending more time in bed. I had already quit work. I was going through the disability process,” she said.

She started looking for alternative therapies and found a stem cell procedure done by a company called Celltex. The therapy takes mesenchymal stem cells out of patients, lets the cells grow and expand, then re-injects them into the patient.

“Those are your healing cells. If you get cut, those are the cells that repair the cut. It’s what helps your system repair itself,” Cowley said.

In 2012, the treatment went public. The first patient Celltex used the treatment on was Gov. Rick Perry, who had terrible back problems.

To finish story, click here.

Stem Cells Regenerate Human Lens After Cataract Surgery, Restoring Vision

By Scott LaFee, UC San Diego

Researchers at University of California, San Diego School of Medicine and Shiley Eye Institute, with colleagues in China, have developed a new, regenerative medicine approach to remove congenital cataracts in infants, permitting remaining stem cells to regrow functional lenses.

The treatment, which has been tested in animals and in a small, human clinical trial, produced much fewer surgical complications than the current standard-of-care and resulted in regenerated lenses with superior visual function in all 12 of the pediatric cataract patients who received the new surgery.

The findings are published in the March 9 online issue of Nature.

Congenital cataracts – lens clouding that occurs at birth or shortly thereafter – is a significant cause of blindness in children. The clouded lens obstructs the passage of light to the retina and visual information to the brain, resulting in significant visual impairment. Current treatment is limited by the age of the patient and related complications. Most pediatric patients require corrective eyewear after cataract surgery.

“An ultimate goal of stem cell research is to turn on the regenerative potential of one’s own stem cells for tissue and organ repair and disease therapy,” said Kang Zhang, MD, PhD, chief of Ophthalmic Genetics, founding director of the Institute for Genomic Medicine and co-director of Biomaterials and Tissue Engineering at the Institute of Engineering in Medicine, both at UC San Diego School of Medicine.

In the new research, Zhang and colleagues relied upon the regenerative potential of endogenous stem cells. Unlike other stem cell approaches that involve creating stem cells in the lab and introducing them back into the patient, with potential hurdles like pathogen transmission and immune rejection, endogenous stem cells are stem cells already naturally in place at the site of the injury or problem. In the case of the human eye, lens epithelial stem cells or LECs generate replacement lens cells throughout a person’s life, though production declines with age.

New technique less invasive than current surgery

Current cataract surgeries largely remove LECs within the lens; the lingering cells generate disorganized regrowth in infants and no useful vision. After confirming the regenerative potential of LECs in animal models, the researchers developed a novel minimally invasive surgery method that preserves the integrity of the lens capsule – a membrane that helps give the lens its required shape to function – and a way to stimulate LECs to grow and form a new lens with vision.

To finish this article please click here.

High-Dose Autologous Stem Cells Help Ms Patient Improve, Reverse Symptoms

Neurologist says MRIs show inactive plaque on lesions of the brain and spine

Debbie Bertrand was diagnosed with Multiple Sclerosis (MS) in 2001 after experiencing a number of troubling symptoms that made it difficult for her to walk and use her hands. Eventually dependent upon a wheelchair but unwilling to simply accept her prognosis, Debbie researched different treatment options and even looked into participating in four different stem cell clinical trials. Unfortunately, she was denied each time, either due to her age or because the trial was closed.

In 2011, Debbie and her husband, Larry, were approached by a church member who recommended Celltex Therapeutics Corporation – a Houston-based biotechnology company with a proprietary technology that can isolate and expand adult mesenchymal stem cells (MSCs) in quantities never before possible for therapeutic application. Debbie received an infusion of hundreds of millions of her own adult stem cells, and within a few months, was able to walk using a walker. She was also able to regain use of her hands. Still, Debbie acknowledges that stem cell therapy is not a cure, but a strategy to help improve her quality of life.

In May 2015, Debbie received her third round of adult stem cell therapy (using her own stem cells expanded by Celltex) at Hospital Galenia in Cancun, Mexico. Since then, Debbie reports noticeable improvements in her stamina and walking gait.

“After we returned from Cancun, I waited a few weeks to let my stem cells do their work. Then my doctor prescribed six weeks of physical therapy to improve my functional mobility. The first day assessment compared to the last day assessment shows that my Berg Balance score improved from a 32 to a 44/56.” According to the Berg Balance Scale, a score of 44 has been shown to be an appropriate cut-off for safe independent ambulation and the need for assistive devices or supervision.

Debbie and her husband now exercise at the gym twice a week from 45 minutes to an hour. Debbie says she wants to increase that to three times a week. “I am standing straight, my back is stronger and I’m walking twice as fast as I used to,” she says. She also reports feeling her left foot for the first time in years.

Perhaps most encouraging of all, Debbie’s recent MRI scans (with and without contrast) show no enhanced plaque on lesions of the brain, neck and spine. Her doctor, Djamchid Lotfi, M.D., a London University graduate and Neurologist, explains:

“The MRI is consistent with the diagnosis of Multiple Sclerosis. At this time, the MRI results show that the plaques in her spine are inactive, and have been inactive for some months. This is a good sign and gives some confidence about the state of the disease.”

Dr. Lotfi has overseen human clinical trials using adult stem cell therapy and says, “There was enough merit there to continue. It was safe and, in most of the cases, the therapy prevented participants from getting worse. In other cases, it improved them. I genuinely believe this is the future of medicine, though many cases like Mrs. Bertrand’s would be considered anecdotal by medical professionals like myself. Stem cell therapy is a novel way of approaching disease management, and, in the future, may be used to fine tune the immune system and help degenerative diseases.”

The Bertrand family continues to champion adult stem cell banking and therapy in hopes of seeing the FDA provide approval so that Americans will have a new, more accessible option in improving their quality of life.

“I am very happy with the results I have seen – not only do I have my doctor’s blessing, I have never experienced any negative side effects. I still take one oral drug for MS, but I haven’t had daily injections for MS in four years. I hope to see this process help others in my situation, and I am thankful to Celltex for bringing this technology to the United States,” she says.