Category Archives: Take Action

Take action to protect your rights to use your own stem cells

♦ FDA Public Hearing On Stem Cell Access – Registration Deadline Jan 8th

Wear this T-Shirt to the FDA hearing!  Available from  Bioinformant.

Wear this T-Shirt to the FDA hearing!
Available from Bioinformant.

Update: Over 600 event registrations arrived at the FDA, causing cancellation of the hearing. Thank you everyone, your voice is being heard! For all the details, see the 3/16/2016 BioInformant post.
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The FDA has announced a 1 day public hearing to obtain input on the four recently issued draft guidances relating to the regulation of stem cell therapy in the U.S. The restrictive proposed regulations will prevent countless patients from receiving this life-changing treatment. The FDA will consider information from medical professional as well as the public/patients on the finalization of these guidances on April 13, 2016.

Read examples here of how stem cell therapy has been making news for saving patients from disabling, even life threatening illness. The FDA regulations would further limit or stop access to these treatments in America.

WE NEED TO LET OUR COLLECTIVE PATIENT VOICE BE HEARD!!!

Step 1: Register for the FDA Public Meeting

April 13, 2016 8:00 a.m. – 5:00 p.m.
FDA’s White Oak Campus
10903 New Hampshire Avenue
Silver Spring, Maryland 20903
Directions
To register by Jan 8th 2015, send an email to: CBERPublicEvents@fda.hhs.gov

Please register even if you can’t attend in person. We are requesting webinar access for those who cannot travel.
Provide the following info in your email.

1. Full name
2. Titles
3. Affiliation
4. Address
5. Email
6. Phone number
7. Your comment

For Affiliation, here are some suggestions:
• Patients For Stem Cells
• Stem Cell Pioneers

Comments are not required, but you can include one about your concerns. Please save it for submitting to the Federal Register. Instruction on how to do this will follow.
Here are some comment examples:

As a “No Option Patient” with a disabling chronic disease, I would like the option to be treated with my own cells, especially when all other FDA approved therapies have failed me. Please consider this when rendering your decision on the minimal manipulation of stem cells.

As a patient who has received cell therapy with quality of life benefits I can attest I wouldn’t be alive today if it wasn’t for the adult stem cell therapy I have received. I should have the right to this therapy here in the U.S. without having to travel offshore.

I am a caregiver of a once vibrant, active and intelligent human being. It is heartbreaking to watch the deterioration of a loved one who could potentially benefit from cell therapy. This a travesty beyond measure.

Step 2: Inform your representative

The FDA is a non-elected appointed regulatory body. Citizens have little recourse to object to the control they are trying to take of the practice of medicine. Please inform your elected Representatives of what is happening.

To find your Representative’s contact and email info, click here.

Step 3: Become an informed advocate

Here is the FDA public notice on the meeting:
Federal Register Notice: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments

Here are the topics rhat will be addressed at the hearing:

    1) Overview of regenerative cells and potential usefulness to medical practice, explaining the scientific data available for us of non-embryonic stem cells, their safety and ethical acceptance.
    2) Forcing US citizens to leave home as medical tourists for untested therapies.
    3) Importance of the physician’s role in the “Practice of Medicine” and the physician patient covenant.
    4) Patient’s Bill of Rights including access to all potential treatments regardless of costs.
    5) Patient’s “Right to Try” laws and the off label use of regenerative cells.
    6) Economic (a) and Academic loss (b) associated with restrictive regressive regulations
    a) Allowing for patient funded clinical studies in the US.
    b) Establishing general and disease specific patient registries designed to collaboratively advance the science and clinical protocols.
    7) Bioethical concerns associated with delaying/denying the aggressive testing and development of quality of life improving and life saving therapies.
    8) The de facto exclusions of these therapies for children in the US.

Thank you for your efforts!

♦ Patient Power Can Accelerate Access to Stem Cell Therapy

You may know from this blog that Patients For Stem Cells (PFSC) is a grassroots effort by patients who want to advance the progress of stem cell therapy. This therapy is an ideal candidate for the accelerated access programs being called for, from the wave of state laws granting “Right To Try” experimental therapies, to the “21st Century Cures Act” moving quickly through Congress.

AACT.coPFSC is pleased to announce we have joined forces with an organization founded with the goal of accelerating access to life saving cellular therapy, The Alliance for the Advancement of Cellular Therapies (AACT)

We’re inviting PFSC subscribers to join AACT as well. They have generously waived the patient membership fee to kick off this partnership!

To join go to AACT.co, click the Membership option and register for Citizen/Patient Membership – Free!

AACT is organizing the Chicago Stem Cell Showcase Sept 17-18. This is where the doctors and researchers in cellular therapy are gathering to explore “The Dilemma of Difficult Diseases: Cell Therapies to the Rescue?

The Speakers are medical professionals at the forefront of cellular medicine, They need our support for sticking their necks out, in a regulatory environment that has been less than accommodating. We can do this by building a strong member base for AACT.

Members will get access to resources including:

  • Clinical trial information and statistics
  • Regulatory information and advocacy
  • Informative newsletter
  • Patient forums
  • Access to conference videos

After the Chicago conference, the presentation videos are going to be an incredible education resource for members. Take a look at the packed Agenda, you may see your own illness is going to be addressed by an expert in the field.

Cellular therapy is rarely covered by insurance in the U.S. except for blood cancers. Accelerated access programs are needed in the U.S., similar to what Europe and Japan are already adopting. Starting with difficult diseases for which there are few medical options, like ALS, Parkinson’s, Alzheimer’s, Multiple Sclerosis, Critical Limb Ischemia, Stroke, Heart Disease and many more. Tracking results of patients enrolled in accelerated access can speed approval and insurance coverage.

One of the founding members of PFSC, SammyJo Wilkinson, has volunteered to serve as Patient Advisory Board Chairman for AACT. She is a stem cell patient herself, and knows the frustration patients face. “The AACT patient portal is where patients can get the facts on cellular therapy in plain language. Then they can make better decisions before joining a medical trial, or spending money on therapies not yet covered by insurance. I am thrilled to be part of the PFSC and ACCT partnership!”

SammyJo will be communicating with members as the AACT website develops these resources, and will represent patient opinions to the Executive Board – especially on FDA issues. If you have opinions or want to get involved now in the advocacy process, send SammyJo an email at info@AACT.co

By becoming a member and inviting others to join, you can “AACT Now” to make a difference!

We encourage you to join the discussion in social media and give us your feedback!

AACT Facebook Twitter Google+ LinkedIn AACT.co

PFSC Facebook Twitter
Want to become a member of Patients For Stem Cells? Just subscribe to our blog!


 

Take Action! Preserve Access To Stem Cell Therapy In The U.S.

Graphics by William Jones and Chelsea Henderson, Lamar University Press

Graphics by William Jones and Chelsea Henderson, Lamar University Press

Your Urgent Help Needed! New FDA Draft Guidance on Physician use of Platelets and Stem Cells Seeks to Drastically Limit What Physicians can do to Help Their Patients

UPDATE: Thank everyone for submitting 381 comments! We will keep you posted on the outcome.
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The public has the opportunity until Dec 22, 2014 to present comments to the FDA regarding regulation of adult stem cells.

You can jump to the TAKE ACTION INSTRUCTIONS below, but here’s the situation.

Patients For Stem Cells opposes this draft exemption in its current form because it further limits access to use of autologous (your own) stem cells to treat illness and injury. Many of our members have found cellular medicine to be safe and effective. Further government restrictions are not needed.

“Those with congressional contacts should make them aware of what is happening. Many of our government agencies e.g. FDA, EPA are taking unprecedented actions. These are unelected government officials making “laws” for US citizens. I doubt this is what Jefferson, Adams, et al had envisioned for our country!”
~ Gerard Malanga Partner at New Jersey Orthopedic and Sports Medicine, LLC

The History: Over the past decade, many things that were previously defined as the practice of medicine in cell based regulations have been moved from physician to FDA control. These have included cell culture and the bedside processing of fat tissue. Now centrifugation could be the next physician right to fall under FDA regulation. This last problem is part of a new FDA draft guidance.

The Issue: Larger and larger numbers of physicians are using platelet rich plasma (PRP), bone marrow concentrates (BMC) or adipose derived Stromal Vascular Fraction (SVF) in their medical practices. These are usually prepared by an automated bedside centrifuge at the point of care (POC). The physician’s ability to process cells in this way has been allowed by FDA through an exemption in its cell based therapy regulations codified in 21 CFR 1271.15(b). This exemption has been narrowed most recently in 2006 to allow simple processing steps like centrifugation, but to exclude culturing or more extensive processing of cells. The draft guidance in question now seeks to narrow this exemption further to manual tissue preparation during the same surgical procedure (i.e. the cutting, shaping, or washing of whole tissue). Curiously exempt from the draft guidance is centrifugation, despite numerous 510K cleared devices in existence that use this technique to isolate platelets from blood or concentrate the stem cells in bone marrow. If the guidance is adopted, the big picture implication is that any physician using centrifugation to process cells at the bedside and part of the same surgical procedure, could be regulated not by his or her state medical board, but also by the FDA. This would mean dramatically increased costs for physicians who would need to register with FDA, to hire expensive consultants to produce tissue processing quality systems, and to employ consultants or other employees to keep the physician’s office up to the standards that the FDA sets for the wholesale processing of tissue. The practical implication of this guidance is therefore that few physicians will spend the time, money, and employee resources to be compliant, either causing them to avoid these simple and helpful therapies or leaving them open to enforcement actions by the FDA.

What can you do now? The FDA has asked for comments on the guidance. They normally receive a few scattered letters from physicians on these issues, but we have the opportunity to make our voices heard on a massive scale. Be sure to share this post!

TAKE ACTION INSTRUCTIONS

Here’s how you can tell the FDA and your representatives what this means to patients, and their doctors.

1. Comment:, see examples below, which you can copy/paste.
Or you can just enter ” I oppose this draft exemption in its current form “.

Click HERE once you have your comment ready. Paste it in the Comment box (opens in a new tab so you can come back to these instructions).

2. Enter your name (required) and location (optional)

3. Under I am submitting on behalf of a third party
Submitter’s Representative: – leave blank
Organization Name: – enter PatientsForStemCells.org

4. Category: choose “Consumer Group”
Do NOT select “Individual Consumer”, or your comments will not show up publicly.

Before you click Continue button to submit,
copy your comment so you can also send to your Representative (step 5. below).

5. Find your Representative and email them the comment you copied, and a link to this post so they can get the background.
Here’s the link https://patientsforstemcells.org/preserve-access-to-stem-cell-therapy-2

It may take a few days for your comment to get reviewed and posted at the Federal Register. You can read the comments here. We will also send out an update on the outcome.

Thank you for your help!


Example comment from patients (please edit and personalize):

I oppose the draft exemption in its current form. As a patient, the access to my body’s own tissue is a serious concern. FDA’s new draft guidance would further limit what my physician can do to help heal or treat my condition. Forcing physicians out of inexpensive autologous cellular medicine (that uses my own cells to help heal or mitigate my disease) and into expensive tissues purchased from a tissue bank or a drug company will limit and not expand access to this type of medical care.

Example comments from physicians (please edit and personalize):

I oppose the draft exemption in its current form. As a physician who uses centrifugation to process autologous cells at the bedside, I am concerned that your recent draft guidance doesn’t explicitly state that physicians can use this technique to help isolate their patient’s cells at the bedside. This will impede my ability to cost effectively treat my patients by forcing me to either register with FDA as a tissue processor or to purchase much more expensive and potentially more side effect laden cellular drugs and or allogeneic tissues.
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I oppose the draft exemption in its current form. Platelet rich plasma and bone marrow concentrates are a key feature of my practice that I have used to help patients recover from orthopedic injuries. Further limiting access to these autologous therapies by not explicitly stating that centrifugation is allowed under 21 CFR 1271.15(b), will force me out of using this type of care for my patients. As a small medical practice, I cannot afford to spend the hundreds of thousands of dollars that registration and compliance with FDA 361 tissue processing guidelines will require.
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I oppose the draft exemption in its current form. Autologous biologics are key to promoting the inexpensive physician led innovation that will help contain the future costs of musculoskeletal care. By not explicitly listing centrifugation and other parts of the minimal manipulation guidelines outlined in 1271, the FDA is reducing physician access to these inexpensive technologies.
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I oppose the draft exemption in its current form. Centrifugation is a technology that has been used for a century by physicians, but is not included under the draft same surgical procedure exemption. There are no safety issues that have been identified with the use of centrifugation by properly equipped labs or through closed systems. The FDA’s own statements in its early document entitled “Proposed Approach to Regulation of Cellular and Tissue-Based Products” are “[t]he agency would not assert any regulatory control over cells or tissues that are removed form a patient and transplanted back into that patient during a single surgical procedure. The communicable disease risks, as well as the safety and effectiveness risks, would generally be no different than those typically associated with surgery.” It’s unclear how the patient safety profile of centrifugation has changed since the late 1990s.

More Info::

Text of the FDA draft guidance Docket # FDA-2013-D-0446 Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability.

The FDA’s Q and A page on the draft guidance

A Regulatory Attorney’s Opinion of the Implications for physicians


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