Help ALS Patients Gain Faster Access To Stem Cell Therapy

Oct 06, 2021
Every 90 mins, someone in the U.S. dies of ALS. It is 100% fatal, with an average life expectancy of only 3 to 5 years. These patients are calling and writing to Congress from their wheelchairs and hospital beds, to get the Act For ALS passed into law. It will give faster access to therapies, like NurOwn, an adult stem cell therapy developed by BrainStorm Cell Therapeutics, which is already helping patients in a Phase 3 trial.

Twitter @ThurmanTough · Sep 12 Look at that grip on that left hand @US_FDA @DrWoodcockFDA. Thank You @BrainstormCell for choosing me for the phase 3 trial.
▪ Before #NurOwn – Can’t lift a gallon of paint or open a bottle of water w/ L hand.
▪ After #NurOwnWorks – Can do both those things + bait a hook or hold up a fish w/ L hand!

Act For ALS will help all patients with rare neurodegenerative diseases. For example, NurOwn stem cell therapy is also in Phase 2 trials for multiple sclerosis. MS is not considered rare, but it has rare lethal subtypes like Marburg’s Variant and PML. If stem cells continue to prove effective for lethal conditions like ALS, this will accelerate regenerative therapy trials for ALL neurodegenerative diseases.

Followers of Patients For Stem Cells know how to make a difference. In 2017 we inundated the FDA hearing on stem cell regulations with patient testimony. In 2018 we helped get H.B. 810 passed in Texas to expedite stem cell trials. Texas has 881 registered trials, second highest in the nation.

Here’s how we can make a difference again. The ALS community has already made huge progress. In the House. 322 of the 435 Representatives have co-sponsored the this bill, with bipartisan support. But we’ve got to act fast to get Senate support.

The vote on Act For ALS Senate Bill S.1813 occurs in October 2021, with the goal of getting signed and funded January 2022. Of the100 Senators, 51 are needed to pass, but the goal is 60. Off to a good start with bipartisan co-sponsors from the Senate leaders, Minority Whip Sen. John Thune (R-SD) and Majority Whip Sen. Dick Durbin (D-IL). But so far, only 28 Senators have co-sponsored, and time is running out. So first let’s cover how you can help make this happen, then we’ll go into more details on what’s in S. 1813.

Help Win Support for Senate Bill S.1813 – Act For ALS

Senators You Can Ask To Co-sponsor Before The October 2021 Vote

Michelle Lorenz is an attorney who has been working tirelessly to advance this bill and explain the legal intricacies to legislators to win their support.

Join Michelle’s Facebook group No More Excuses! ALS Watch Dog Group.
Go to the Sept. 30th post to see latest details on Senators to contact. Check this link Senate Bill S.181 to see if your own Senators have co-sponsored yet. If they have, send them an email thank you!

For Senators who have not co-sponsored yet, send an email, then follow up with a call and ask for the Legislative Director. You can say
I’m calling to ask the Senator to co-sponsor the ACT for ALS, Senate Bill 1813. That’s 1-8-1-3. ALS is 100% fatal and untreatable. This will help people who are Dying Waiting to get access to potentially life-changing treatments that are stuck in clinical trials. Can we schedule a 45-60 minute Zoom call with the Senator, myself and Michelle Lorenz, a legal expert on S.1813 who will explain the bill?
If they say yes say Thank you so much, Michelle’s assistant will be in contact to schedule the Zoom call.
If you get a yes, return to Michelle’s Sept. 30th post and follow the instructions to schedule the Zoom.

How To Email and Call Senate Offices
The websites below make it very easy to send an email script. There are also call scripts so you know exactly what to say when you follow up after the email. The call is when you ask if they will schedule the Zoom call. All emails and calls are counted, and help show support for the bill.

From the scripts at the sites below you will get all the details you need on S.1813.
If don’t have ALS yourself, edit the the script with this:
I am writing on behalf of your constituents who are paralyzed by ALS and can no longer speak or write.

For iPhone or Mac Safari Browser go to helpmayuri.com
This app makes it very easy to send an email script with all the details. Then a call script to follow when you call the Senator’s staff. This site lets you contact ALL Congressional offices in any state. Have your signature info ready to paste at the end with full name, address, phone, to make sure they count you as a real person.

For PC Web browsers, Chrome or Edge go to iamals.org/legislation/act-for-als/
This site lets you send an email script to the Senators in your own state. Only takes 60 seconds. For the follow up call, see phone numbers above.

What’s In Act For ALS: Expanded Access To Life Saving Therapies for Rare Neurodegenerative Diseases

The ACT for ALS makes Right to Try a reality.  As you may recall, the Right to Try law was named after a Navy pilot with ALS, Matt Bellina. But because of a lack of funding to pay for the therapies, Matt Bellina was the only 1 of 30,000 people with ALS who was able to use the law to get access to drugs stuck in trials.  The ACT for ALS will change this inhumanity.

Senate Bill 1813 is a simple bill with three primary prongs:

1) An Expanded Access program for drugs in Phase 3 clinical trials for people with ALS.  The grant fund is only available to small biopharma companies & the clinical trial sites dispensing the therapy;

2) A Public-Private partnership of HHS officials, clinicians, patient advocates & researchers that mirrors the Center of Excellence for Oncology that was created in the 2016 Cures Act;

3) A research grant fund to facilitate development of drugs & expedite access to those drugs for rare, neurodegenerative diseases.

Patient Resources & More Ways To Advance Therapies For Neurodegenerative Disease

Share this post. Then go to the sites below and share the posts on Facebook and Twitter that ALS patients are posting about how devastating ALS is. And how important Act For ALS is to them. These posts have name tags of the politicians and FDA regulators, so high volume sharing will get their attention.

No More Excuses ALS Official Twitter Facebook

I Am ALS join on Website Twitter Facebook
A patient-led community that provides critical support and resources to patients, caregivers and loved ones. We empower advocates to raise mainstream awareness and lead the revolution against ALS in driving the development of cures.

Society With MS If you have MS, join our all volunteer non-profit, founded by MS patients. Dedicated to speeding development of neurodegenerative therapies that repair the damage caused by MS. Our members are also working to help the ALS community pass the Act For ALS!

Patients For Stem Cells Like our Facebook page for the latest news on stem cell therapy and advocacy. We now have over 4500 followers, so you can discuss stem cell therapy with other patients.

Thank you for taking action! Together patients can change the course of medicine towards regenerative biological therapies.

Progress For Patients: Texas Stem Cells Law and Federal Right To Try

Austin, TX – May 20th, 2018 Elizabeth Jeneault, host of “In Focus” on Spectrum News, interviewed the people behind the passage of historic legislation that is changing the face of medicine, by putting patient’s rights first.

Patients For Stem Cells, founding members Jennifer Ziegler and Tracy Thompson
Click to watch interview

Jennifer and Tracy share how their advocacy work  over many years led to passage of Charlie’s Law, Texas HB 810, that was signed into law in 2018. This law will allow adult stem cell treatment in Texas for terminal and critically ill chronic patients.

Rep. Tan Parker on Charlie’s Law, TX HB 810 Stem cell Law
Click to watch interview

 

 

 

 

 

 

 

State Rep. Tan Parker (R), author of Charlie’s Law, explains why he’s passionate about allowing adults to access their own stem cells for helpful health treatments.

KK125 Ovarian Cancer Research Foundation on Right To Try
Click to watch interview

Michelle Wittenburg, President of The KK125 Ovarian Cancer Research Foundation discusses how a personal loss drove her to advocate for adult stem cell therapy, and other beneficial ovarian cancer treatments utilizing the Texas Right To Try law.

Ten days after these interviews were given, the federal Right to Try  Act was signed into law on May 30th, 2018.  President Trump Signs Right to Try Act Into Law.

FAQ

What started the Texas movement?

The advocacy efforts started in 2007 in Texas.  At that time, Patients for Stem Cells (PFSC) was not in existence.  Two women who would later become founding members of PFSC were active at the state level in advocacy and helped educate on the promise adult stem cells hold.  By 2011 after much education and visibility at the state capitol an effort was led by then State Representative Rick Hardcastle.  Chairman Hardcastle lost his daughter at the age of 17 to cancer and shortly after he was diagnosed with MS. Due to Chairman Hardcastle’s efforts and two of the founding members of PFSC, a clinic opened in Houston to treat patients with expanded stem cells.  Governor Rick Perry was the first patient and Chairman Rick Hardcastle was patient number 5.  Founding members of PFSC were also treated.  However, this was short lived.  The FDA ruled in Sept. 2012 that expanded stem cells were a drug, subject to the lengthy FDA approval process. This required the clinic to cease treating patients in the U.S. One of us was mid-treatment when this occurred. Having worked for years to gain access to this treatment in the U.S. and then have hopes crushed was devastating. This is what inspired the formation of PFSC in Oct. 2012, building on the effort that started over a decade ago, and has now expanded to a nationwide network. This has been an effort in the making for over a decade, culminating in two significant pieces of Texas legislation, The Right To Try Act in 2015, and TX HB 810, Charlie’s Law in 2017.

We want to thank Chairman Hardcastle, Chairman Tan Parker, the bill author, State Representative Drew Springer, co-sponsor, and State Senator Paul Bettencourt for sponsoring the Senate version.  They were great champions in passing HB 810 with unanimous bipartisan approval.

We are forever grateful to so many people that made this a reality.  The dedication and compassion was overwhelming.  This is something that can be done by every state in our nation.

What’s the difference between Right To Try Laws and Texas HB 810?

Since 2014, 40 states have passed Right To Try laws. The Right To Try law gives terminal patients the right to try experimental drugs or biologics. The success at the state level was the driving force in passing the federal law in 2018.

Texas HB 810 extends this right to chronically ill patients, but only for biologics, like adult stem cell treatments. We support regulation and want accountability within the industry. However, this should fall under the practice of medicine and is something that can be regulated at the state level. HB 810 is not perfect, but it is a starting point. We will continue to work to improve this and do it in a responsible way, offering a safe and regulated environment.

Can I get stem cell therapy in Texas now?

No, not yet.  HB 810 went into effect in Sept. 2017.  However, it had to go before 2 state agencies to define regulations. The first step was for the Texas Medical Board to do their rule making process. It is now before the Texas State Department of Health and Human Services to establish which conditions can be treated. This decision is expected in the fall of 2018. We will publish when this is available.  Until that time, there are no clinics operating under HB 810.

So why do I see many clinics in Texas and other states offering stem cell therapy?

These are clinics offering low dose stem cell therapy, that is extracted from adipose tissue and then infused into the patient on the same day. These clinics are all operating outside of FDA guidelines and are subject to enforcement at any time as we have seen with the recent injunctions against Cell Surgical Network and US Stem Cell Clinic. These were two of the largest and most visible nationwide networks offering same day cell procedures for a myriad of diseases. There are about 600 clinics offering treatments and the vast majority are doing so outside of guidelines.  This is NOT the same therapy as expanded high dose stem cells. If a same-day clinic says they are operating under Right To Try or TX HB 810, they are being misleading. The exception to this is same-day orthopedic treatments using bone marrow derived stem cells, which is still allowed under the FDA’s regulations.

Will patients have to pay to be in these trials?

At this time the cancer treatments are being paid for by the patient, and it is expected the expanded stem cell therapies will also be paid for by the patient. The benefit to patients is that they no longer have to incur the extra expense or inconvenience of offshore travel. Offshore travel is not even possible for many patients who are very sick, so by bringing the treatments back to the U.S. it removes one more barrier.

When will the treatments given under TX HB 810 and Right To Try be covered by insurance?

None of these therapies  are covered by insurance at this time. The treatments likely will have to continue through the FDA approval process. However, in 2017 the momentum created by Right To Try laws being passed in many states, as well as patient activism, the 21st Century Cures Act was signed into law. This Act provides the FDA with the flexibility to accelerate how it evaluates regenerative medicine treatments, such as stem cell therapies.. It is possible that the data generated from the trials in Texas may be used in this process, and help gain faster FDA approval, the prerequisite to insurance coverage.

What type of cancers are being treated under the Right To Try law in Texas?

The Texas Right to Try law went into effect in June 2015, since then at least 78 patients have received an experimental cancer treatment not allowed by the FDA for Neuroendocrine Tumors. Dr. Ebrahim Delpassand is conducting a trial at Excel Diagnostics & Nuclear Oncology Center in Houston TX. Click HERE for information on the therapy, and contact information.

Also see Who’s Actually Using ‘Right-To-Try’ Laws? A Texas Oncologist Explains his Experience
Also see Right To Try Is Working

For information on ovarian cancer, contact  The KK125 Ovarian Cancer Research Foundation

What can we do as patients?

The power of the patient voice is gaining momentum.  This has been a landmark year for patients. The federal passage of Right To Try and the first ever state law allowing expanded adult stem cell treatments for chronic/terminal patients is so exciting.  We see great potential moving forward, and are already working with other states to implement the model that was passed in TX.  Every state needs passionate, educated advocates to put a face to the issue and make it a reality. There is so much power in patient advocacy.  However, we must craft a very positive effective message.  It’s about protecting our constitutional right to self-preservation in the face of chronic/terminal illness.   We must remain bi-partisan and work together to take this movement to the next level.  We feel this model will be the next phase of Right To Try and we want it now rather than later.

Telling your personal story and getting involved can be intimidating.  Never underestimate the power of the patient’s voice.  There were many times we felt inferior during this process.  It can be very emotional to put yourself out there. It is all well worth it when you hear from the legislators that personal stories are what make bills into laws.  It takes putting a face to the bill that brings it to life.  The moral of the story is never underestimate the value you can bring. Some of us are not physically able to be there in person, but can still contact their law makers  via phone and email.

Our subscribers to the PFSC blog have been an amazing support to us when we’ve made a call to action, contacting their legislators and regulators. Please continue to share our posts far and wide to get the message of hope out there to all patients. Thank you to each and every one of you!

Want to get involved in your state? Please contact us!

Join the conversation with other patients on our Facebook page and Twitter.

The Patients For Stem Cell Team

 

Episode 4 – The Healing Miracle Of Stem Cells

I hope everyone is signed up to receive the daily episode via email. I failed to post yesterdays episode where Michelle Wittenburg a Texas Lawyer, Lobbyist, and Advocate who was key in the passage of HB 810, Charlie’s Law, was interviewed. She did an outstanding job explaining why patients have to be the focal point and how this is no longer the case in most situations. WE AS PATIENTS must demand better!

In todays episode you will see an interview by Dr. Neil Riodan. His enthusiasm is contagious as he describes the breakthroughs his company has made in stem cell therapy.

In order to avoid the tangle of medical bureaucracy that exists in the US, Dr. Riordann relocated to Panama—where many people have benefitted from his cutting-edge treatments and incredible progress is being made in the field of research.

In the last ten years, Riordan has treated over 5,000 patients suffering from a wide range of injury and disease. He will fascinate you with his detailed, well-explained description of how stem cells team with other cells to heal and regenerate. And, the success he is seeing in patients with Autism, Duchenne MS, arthritis, auto-immune disease and spinal cord injury will amaze and inspire you.

This father of four is especially passionate about healing progressive childhood diseases, and he is seeing excellent results in young patients whose lives would otherwise be overshadowed by life-limiting genetic conditions or injuries that have, until now, been considered untreatable.

This episode expires at 7pm CST tonight and episode 5 will then become available. We are hoping to post some of the highlights of the series once it is released in its entirety on this site. When we work through the logistics we will post.

Have a wonderful weekend and thank you all for your support!

PFSC Team

Episode 4