Attorney General Peterson Files Lawsuit Against Stem Cell …

Attorney General Expresses Concern About Stem Cell Clinics Advertisements and Cure-All Claims

LINCOLN Attorney General Doug Peterson filed a Complaint today in the District Court of Douglas County against Omaha Stem Cells, LLC, Regenerative Medicine and Anti-Aging Institutes of Omaha, LLC, Stem Cell Centers, LLC and Travis and Emily Autor (collectively the Defendants). The case relates to the Defendants marketing and sale of stem cell therapy to consumers, often following aggressive marketing through local media and in-person seminars throughout Nebraska and Iowa. The Defendants operated a clinic until recently in Omaha. The Attorney General conducted his investigation in cooperation with Iowa Attorney General Tom Miller, who filed a similar lawsuit today in Iowa.

The Attorney General alleges the Defendants made over $2 million by making deceptive and misleading statements to consumers regarding the ability of their stem cell therapy to treat specific diseases and health conditions, including joint pain, back pain, osteoarthritis, neuropathy, and COPD. The lawsuit also alleges the Defendants misrepresented that stem cell therapy is safe and that larger doses are more effective, without possessing the necessary evidence to make these types of claims.

In his lawsuit, the Attorney General acknowledges prior statements by the FDA that stem cells have the potential to repair, restore, replace and regenerate cells, and in the future could possibly be used to treat many medical conditions and diseases. However, stem cell use for most medical conditions remains unproven and, therefore, unapproved by the FDA. In September 2019, the FDA warned consumers that the unapproved use of stem cell treatments can be particularly unsafe, and may lead to adverse reactions, such as the failure of cells to function as expected and tumor growth.

Unfortunately, this warning may have come too late for some consumers in Nebraska. In December 2019, the FDA issued a more specific Public Safety Notification regarding multiple reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. According to the Attorney Generals lawsuit, the Defendants were advertising and administering unapproved exosome products to consumers.

Attorney General Peterson stated, Consumers are entitled to accurate and truthful information about any product or service, but especially those products that affect their health and wellbeing. With todays filing, we remind all healthcare providers and other businesses that they will be held accountable for the representations they make to consumers.

Consumers in Nebraska, and across the country, need to heed these warnings when it comes to stem cell products. According to the Attorney General, Travis and Emily Autor operate a network of companies across the country that advertise and sell stem cell therapy directly to consumers. In addition to their clinic in Omaha, the Autors have been affiliated with clinics located in Arizona, Florida, Idaho, Montana, Vermont, Virginia, and Washington.

According to the FDA, those considering whether to undergo treatment with stem cell products, including exosomes, should:

Ask if the FDA has reviewed the treatment before getting treatmenteven if the stem cells are their own. Ask their health care provider to confirm this information.

Make sure they understand the entire process and known risks before consenting to participate in a clinical trial. To participate in a clinical trial that requires an Investigational New Drug Application (IND), the consumer must sign a consent form that explains the experimental procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects.

Be cautious when considering treatment in another country. Know that the FDA does not have oversight of treatments done in other countries.

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Attorney General Peterson Files Lawsuit Against Stem Cell ...

Upper Cervical Ligament Stem Cell Injection: Restores Hope …

The car accident was at low speed and you hit your head on the headrest. You are left with constant headaches, dizziness, and mental fog that is all new. Regrettably, your doctors are all baffled and think it may be psychological or post-traumatic stress disorder. What is craniocervical instability? What causes craniocervical instability? How is craniocervical instability treated? Are there non-surgical treatment options? Whats an upper cervical ligament stem cell injection? Lets dig in.

First, some basic anatomy and terminology are required. Your head is also referred to as the cranium. The neck is also known as the cervical spine. The craniocervical junction is simply where your head meets the neck. The head is connected to the cervical spine by important ligaments. These ligaments provide important stability that keep your head, brain, and spinal cord snugly attached to your neck. Damage to the ligaments can cause excessive movement between the head and neck which is called craniocervical instability (1).

Trauma, degeneration, and genetic disorders that affect collagen and ligament strength all can cause craniocervical instability (2). The most common symptoms associated with CCI include

Severe Headache: Unlike the garden variety headache this is a headache that is constant, involves most of the head, and stops you in your tracks.

Dizziness/Balance Dysfunction: Simple tasks like walking down the hall or across the street are impossible at times due to the dizziness (3).

Brain Fog: Mental fog and delayed mental processing that prevent completion of simple tasks such as domestic chores and self-care.

Other symptoms may include increased heart rate, changes in GI function, visual problems, irritability and mood swings

The severity of the craniocervical instability dictates treatment. Conservative care is the first-line treatment when appropriate and includes chiropractic care and cervical stabilization. When these fail many patients are referred for surgery. The surgery is significant and involves a fusion of the back of the head (occiput) and cervical spine. It involves screws that are placed in the skull and cervical spine and rods that connect the two. The goal of surgery is to stabilize the head/neck junction. The surgery is extensive, fraught with risks, and forever changes a patients ability to move the neck and head. The x-ray in the featured image is an occipital cervical fusion used to treat CCI.

Surgical fusion was the standard treatment of CCI until 2015 when the Centeno-Schultz Clinic developed the first nonsurgical treatment. The procedure involves the placement of a patients own bone marrow-derived stem cells into the damaged ligaments that stabilize the craniocervical junction. The stem cells are injected through a needle that is placed in the back of the mouth and carefully advanced into the damaged ligaments using x-ray guidance. The procedure is called the PICL which stands for the Percutaneous Injection of Cervical Ligaments. It is an extremely demanding procedure given the spinal cord and other important structures are only millimeters from the injected ligaments. Orthopedic surgeons and neurosurgeons are not able to perform this procedure. In fact, the Centeno-Schultz Clinic is the only place in the world that performs the PICL procedure. The Craniocervical Joint (CCJ) Instability Institute provides an in-depth opportunity to learn more about CCI and regenerative options. To learn more about the PICL procedure please watch the video below.

Treatment results to date have been transformative and in many cases life-changing for many patients. Today I had the pleasure of seeing one of my patients who underwent the PICL procedure. Meet Mike.

Craniocervical instability involves excessive movement between the head and neck. Ligaments are thick bands of connective tissue that connect one bone to another. Cervical ligaments provide stability for the head-neck junction. Damage, wear and tear, and genetic disorders can compromise these ligaments leading to instability. Vital structures such as the brain, brainstem, spinal cord, and nerves are irritated during this excessive movement. Traditional treatment for symptomatic cases of CCI that failed conservative care involves the fusion of the head to the spine. The PICL is an effective, non-surgical treatment option for patients with craniocervical instability. This unique upper cervical ligament stem cell injection procedure allows patients to use their own bone marrow-derived stem cells to accelerate healing of the damaged or weakened ligaments and avoid the complications of surgery.

1.Offiah CE, Day E. The craniocervical junction: embryology, anatomy, biomechanics and imaging in blunt trauma.Insights Imaging. 2017;8(1):2947. doi:10.1007/s13244-016-0530-5

2.Klein GN, Mannion AF, Panjabi MM, Dvorak J. Trapped in the neutral zone: another symptom of whiplash-associated disorder?.Eur Spine J. 2001;10(2):141148. doi:10.1007/s005860100248

3 Thompson-Harvey A, Hain TC. Symptoms in cervical vertigo. Laryngoscope Investig Otolaryngol. 2018;4(1):109115. Published 2018 Nov 28. doi:10.1002/lio2.227.

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Upper Cervical Ligament Stem Cell Injection: Restores Hope ...

Stem Cell Therapy for Neuropathy | Mayo Clinic Connect

Hi @jlsoerens One of the focus areas on Mayo Clinic's Regenerative Medicine Program is in neuroregeneration. You can read more here: https://www.mayo.edu/research/centers-programs/center-regenerative-medicine/focus-areas/neuroregeneration Scroll down the page and you can read clinical research being done specifically for peripheral nerve regeneration and repair.

Unfortunately, because of the complexity of the brain and spinal cord, little spontaneous regeneration, repair or healing occurs. Therefore, brain damage, paralysis from spinal cord injury and peripheral nerve damage are often permanent and incapacitating.

To learn more, you may wish to contact Mayo Clinics Regenerative Medicine free Consult Service. If you call them, you will talk to a live person who will provide more information, research, and advice on seeking stem cell therapy from reputable providers, even if that provider is not Mayo Clinic. Their primary goal is to educate and help you find effective treatment. Furthermore, you can add your name to a database to be notified when additional studies and information become available. Heres more information about the stem cell Consult Service http://www.mayo.edu/research/centers-programs/center-regenerative-medicine/patient-care/clinical-services/regenerative-medicine-consult-service. Or simply call 1-844-276-2003 to speak with one of our experts.

I also feel it important to add it is so important to do your homework and due diligence when researching new treatment options. Stem cells offer a lot of hope. But where these is hope, there is hype and charlatans. FDA acts to remove unproven, potentially harmful treatment used in stem cell centers targeting vulnerable patients https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm573427.htm

You can read more about stem cells on the FDAs website here: https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm

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Stem Cell Therapy for Neuropathy | Mayo Clinic Connect

Comparison of Early and Late Transplant-Associated Thrombotic Microangiopathy – Hematology Advisor

Transplant-associated thrombotic microangiopathy (TA-TMA) is generally regarded as an early complication of hematopoietic stem-cell transplantation (HSCT); however, late TA-TMA appears to be nearly as common as early TA-TMA and both have similarly poor outcomes, according to findings published in the American Journal of Hematology.

In this retrospective study, the investigators aimed to characterize the risk factors and outcomes associated with early and late TA-TMA among patients receiving allogeneic HSCT. The researchers reviewed electronic medical records of adult patients who received allogeneic HSCT at the Mayo Clinic in Rochester, Minnesota, from January 2000 to June 2019. Patients were diagnosed with either early (before or on day 100 post-HSCT) or late (after day 100 post-HSCT) TA-TMA based on laboratory criteria.

Of 1451 HSCT recipients, 84 (5.8%) were diagnosed with TA-TMA at a median of 80 (range, 3-2595) days post-HCST: 45 patients (3.1%) were diagnosed with early TA-TMA at a median of 28 (range, 3-91) days and 39 patients (2.7%) were diagnosed with late TA-TMA at a median of 303 (range, 122-2595) days.

Of evaluated risk factors, patients with early TA-TMA were more likely to have calcineurin-inhibitor toxicity (66.7% vs 30.8%; P <0.001), acute graph-vs-host disease (GVHD; 66.7% vs 28.2%; P <.001), and prior HSCT (28.9% vs 5.1%; P =.005) compared with patients with late TA-TMA. Patients with late TA-TMA were more likely to have chronic GVHD during TMA than those with early TA-TMA (84.6% vs 0.0%; P <.001).

The median follow up was 6 months (range, 0-132). The overall mortality rate was 34.5% at 3 months and 66.7% at the end of follow up. The estimated median overall survival (OS) was 6 months. After 1 year and 3 years, no differences were observed in survival of patients with early and late TA-TMA (1-year, 36.4% vs 48.9%; 3-year, 33.9% vs 32.9%, respectively). The estimated median OS was not reached in patients who had improvement of TA-TMA, whereas in patients with no improvement, it was 2 months (P <.001).

In a multivariate analysis, older age (for every 10 years, hazard ratio [HR], 1.40; 95% CI, 1.00-1.94; P =.049) and bacterial infection (HR, 2.42; 95% CI, 0.98-6.00; P =.056) were positively associated with mortality in the early TA-TMA group. Conversely, switching from calcineurin-inhibitor to mycophenolate mofetil treatment (HR, 0.40; 95% CI, 0.16-0.99; P =.047) and improvement of TMA (HR, 0.08; 95% CI, 0.03-0.25; P <.001) were negatively associated with mortality in the early TMA group. Only 1 independent predictor, improvement of TA-TMA, was associated with a lower risk of death in the late TMA group (HR, 0.05; 95% CI, 0.02-0.19; P <.001).

Limitations of the study included its retrospective design and variable patient management; additionally, some patients may have been undiagnosed or diagnosed later than the onset of TA-TMA.

In conclusion, the characteristics and etiologies of early and late TMA may be different, but outcomes are similarly unfavorable. Future studies are needed to shed light on methods for a timely diagnosis, better definition of triggers of TMA, and to bring more targeted treatment options, concluded the authors.

Disclosures: Some authors have declared affiliations with the pharmaceutical industry. Please refer to the original study for a full list of disclosures.

Heybeli C, Sridharan M, Alkhateeb HB, et al. Characteristics of late transplantassociated thrombotic microangiopahy (TATMA) in patients who underwent allogeneic hematopoietic stem cell transplantation [published July 2, 2020]. Am J Hematol. doi: 10.1002/ajh.25922

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Comparison of Early and Late Transplant-Associated Thrombotic Microangiopathy - Hematology Advisor

Friday Frontline: Cancer Updates, Research and Education on July 17, 2020 – Curetoday.com

From U.S. Supreme Court Justice Ruth Bader Ginsburg being released from the hospital after an infection related to treatment for pancreatic tumor to Alex Trebek giving an update on the treatment of his stage 4 pancreatic cancer just days ahead of his 80th birthday, heres whats making the headlines in the cancer space this week.

In August 2019, Justice Ginsburg, 87, the senior member of the U.S. Supreme Courts liberal wing, underwent treatment for a malignant tumor on her pancreas. The bile duct stent was inserted during this treatment.

She is home and doing well, Kathleen Arberg, a Supreme Court spokeswoman, said in a statement after Ginsburg was discharged. Initially it was believed that Ginsburg would have to be in the hospital for multiple days, but she was discharged earlier than expected.

A cancer survivor who had received multiple rounds of treatment as a child graduated high school as the valedictorian of his class amid the COVID-19 pandemic.

In 2014, John Hagen was interviewed on camera while at St. Jude Childrens Hospital toward the end of his treatments for T-cell acute lymphoblastic leukemia and when asked what he wanted to be when he grew up he answered, Architect, I love math and geometry is my favorite subject.

However, shortly after the interview, Johns cancer returned and he had to undergo a stem-cell transplant as multiple organs were failing. Things were so bad that we were really living minute-to-minute, said Kathy, Johns mom and eventual stem-cell donor, in an interview reflecting on Johns graduation and journey. At the time, the family was preparing for the worst but eventually doctors at St. Jude were able to identify Johns mother as a donor.

Johns father recently reached out to the doctors at St. Judes who treated him to thank them and let them know John was graduating valedictorian, attending college in the fall and had switched his career path toward the medical field. He received a warm reply just a few minutes later.

A cancer survivor was hospitalized for over three weeks due to a COVID-19-related infection and is now back in the hospital for COVID after being discharged.

Went through chemo, radiation and to be honest with you, I mustve been lucky because this is so much worse than me going through cancer, Kelly Warrick, 49, said in an interview comparing her COVID-19 experience to her cervical cancer journey a few years ago.

According to Warrick, she was discharged from Memorial Hermann Health System in Texas on Friday July 10, but had to return to the emergency room the next day.

I do understand it hits people differently, but you dont know how its going to hit you so its not something to mess around with, Warrick said.

Six days ahead of his 80th birthday, Jeopardy! host Alex Trebek released a video updating fans on his health amid his treatment for stage 4 pancreatic cancer.

"I'm doing well, the Jeopardy! host said in an interview showing off his quarantine goatee. I've been continuing my treatment, and it is paying off, though it does fatigue me a great deal. My numbers are good, I'm feeling great."

The positive update comes after Trebek opened up about handling depression related to his treatment as well as side effects that lead to moments of great pain, as well as, his hair loss and trouble to enunciate during speech.

While at home, Trebek will continue to film openings that will precede airings of classic Jeopardy! episodes throughout the rest of the summer.

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Friday Frontline: Cancer Updates, Research and Education on July 17, 2020 - Curetoday.com