FDA Stem Cell Hearing

FDA Stem Cell Hearing

posted in: AVN, Regenexx, Regenexx | 8

(Impatient and don’t want to read the whole post? Just scroll all the way to the bottom to watch the video!)

Sometimes I find myself in situations and think, “How the hell did you get here Julie?”

Seriously. I mean, to be speaking at an FDA hearing on stem cells? And then I think . . .“Only me, only me.”

But then I look around the room and realize it’s not just me.

I’m not the only person that wants to make a difference in this world for patients. There are so many others just like me! I’m one of many. I’m just working as hard as I can to help move forward a patient centered healthcare.

I had the opportunity to very briefly give a highlight of my stem cell journey Center for Biologics Evaluation and Research, Food and Drug Administration hearing in September 2016.

Preparing For The Day

In the Spring of 2016, I attended an FDA meeting specifically for psoriatic disease. It was held at the FDA campus in Maryland. I found it really interesting and I loved being there. I wasn’t one of the featured speakers at the psoriasis event, but me being me, I knew I couldn’t let the opportunity to speak at an FDA meeting pass me by. So I luckily grabbed the last public comment spot and was able to still make a comment during the meeting. Want to watch it? Check out the video here.

Summer L Scirocco on Twitter

“@justagoodlife speaking on GMO and effects on #psoriasis AND #psoriaticarthritis has on life to the @US_FDA #PFDD”

Alisha and I had the honor of helping represent

Alisha and I had the honor of helping represent the psoriatic disease voice today at the FDA Patient Focused Drug Development meeting specifically surrounding Psoriasis. Empowered patients shared inspiring stories today. There were tears shed, laughter shared, and hard times explored. Our community is SO strong, SO resilient and SO mind blowingly brave.

When I saw there was going to be an FDA public hearing on stem cells, I knew I needed to share my story. I inquired for a speaking spot and really hoped that I would get one.

Originally the hearing had been set for April 2016, but due to an overwhelming response to come and testify, the date had been postponed and expanded to 2 days. They also held a workshop the week prior to the hearing.

In the summer, I was notified that I had been selected as a speaker and was assigned speaker #59. I was told I had 5 minutes and I had to stick to the allotted time slot because there were so many individuals speaking during the two days.

This trip was going to be all on my own dime. But, because I felt so strongly about it, I knew I had to be there in person. It had taken me years to find a solution to my problem and I believe that is unacceptable. Procedures and treatments like this need to be readily available for all patients to tap into.

Before hand, I made note cards, outlined what I was going to say, and practiced multiple times. Each time it came out a little bit differently.

And I’ll be honest. . . I didn’t know the best way to present at an FDA hearing. But, what I did know, is that I wanted to speak from the heart.

I know my story so well. I didn’t need to do research or write down facts to make sure they were right. I just knew I needed to get up there and be as authentic as I could. And that’s what I planned to do.

I prayed for guidance. I prayed that whatever would come out of my mouth that day would be exactly what the hearing committee needed to hear to move forward with regulations in favor of all patients.

 

Getting To The Hearing

My best friend just moved to the DC area and was nice enough to let me stay at her beautiful home. I’ll be honest, I look for any excuse to go and visit her and her family!

The hearing took place on September 12th and 13th, 2016. The morning of the second day, I drove to the National Institutes for Health (NIH) campus. Having gone to the FDA campus earlier that year, I figured I would need to go through a metal detector, but I did not anticipate what was going to happen at the NIH.

I pulled up and they had me pull into this little garage. The woman then instructed me to take all of my bags out of my car. Now let me tell you this: I had just driven 4 1/2 hours to my friend’s house to stay, and then drove up to the NIH building, and was planning on driving back home afterwards.

So I had luggage, I had my computer bag, I had a cooler, I had 2 purses, I had my yoga bag, and then all of the other crap that I keep in my car. Yep, all of that had to go through the scanner. I probably looked ridiculous carrying 25 different bags.

The bags and I moved into a small room, passed through the metal detector and then I was able to walk back out to my car.

In the meantime, my car was inspected. The hood was opened and the handles were swabbed. There was a bomb sniffing dog and they looked through my car.

The staff actually made it pretty seamless – the whole thing probably took about seven minutes. Which, to be honest, could’ve taken a lot longer.

Once myself, my bags and my car passed inspection, I was given a badge and a little paper to show that I went through the security. A nice man highlighted a map for me so that I knew how to get to building 10. And then I was on my way!

As I started driving through the NIH campus, I stopped to admire the beauty of it. It really is a nice campus. It reminded me of a college campus, except everyone was walking to work instead of class. The buildings? Some newer, some older. And I noticed quite a bit of construction going on. All in all, I was impressed with the beauty of it.

I found building 10, after eight stop signs (thanks to the security man who told me to count them), got to the parking garage, parked my car, walked in the building and found my way to the auditorium. I checked in, got my speaker badge, and they took me to my seat. The day started within two minutes of me sitting in my seat! It was pretty much perfect timing.

 

The Main Event

The hearing had actually started the day before and they were continuing with different foundations and nonprofits speakers. I would have really liked to have attended the first day, but with my travel schedule that week (I was already missing work to go to Stanford Medicine X) I knew I couldn’t miss another day.

As I watched the foundations speak, I realized that everyone was reading off a paper script. They had written out exactly what they were going to say and were reading right from it.

There was one woman who really impacted the audience. Shelley Ross, the president of the Cure Alliance, talked about her own personal experience with stem cells and how it helped get her back to living her life. (Click here to watch her presentation)

I’ll be honest, there were many things that these presenters were saying that went completely over my head. I feel like I have the basic understanding of this treatment, but I will not sit here and pretend I know all the ins and outs.

There was a break after the first set of speakers and then I was shortly up next!

The first man in our group did not show. I figured that time would be running late, but we actually went ahead of schedule.

As I sat in my seat, I started to get very nervous. I felt like I was going to get up there and not remember everything I had wanted to say. I knew I had notes on my note cards, but for some reason I felt like I was going to get up there, start looking at their faces and never look down at the note cards.

But before I went up to the podium, I looked down at my phone and it was 11:11.

If you’ve followed my story, you may realize that I always credit my Pap Pap for helping me find this procedure. It was the summer that he was dying of lung cancer that he promised me as soon as he got to heaven he was going to find me a solution.

A week or two after he passed away, I came across the Regenexx procedure.

You may believe, or you may not believe, but I truly believe that he has been by my side ever since. I’ve never felt so connected and so close to someone who wasn’t physically in my presence.

Once I looked down at my phone, and saw that he was with me, I knew it was going to be all right. I knew everything that I was going to say would have an impact.

I wanted to speak from my heart and that’s what I definitely did. I got up there, never looked at my note cards and tried my best to wrap it up within my 5 minutes.

Of course I always over analyze everything I say and don’t say. There were things that I forgot to mention and there were definitely facts I wish I would have honed a bit more on. But, overall, I felt like I made an impact.

(Keep scrolling down to watch my testimony or click here)

 

The Aftermath

After my short presentation, the rest of the speakers went and then we had a break for lunch.

During the break, many people came up to me and thanked me for standing up and sharing my story. Several of them mentioned it was a “breath of fresh air” and broke up the monotonous tone of everyone reading from their papers.

The feedback I received made me realize I had definitely made an impact on the room. I ended up leaving with a stack of business cards!

Many speakers had specific points related to the draft guidance that they were seeking comments on. I’ll be honest, my five-minute speech did not address specifically what they outlined.

And I did that on purpose.

I’m not going to pretend to know everything there is about stem cells. I’m not going to pretend to know what should be regulated and what the guidelines should or shouldn’t be.

But what I do know is that I’m an expert in my own story. And by telling my story, and why I chose Regenexx (because I was weary of other stem cell procedures  and I wanted the ability to use my own stem cells), I knew that I could have some kind of impact on pushing regulations forward.

Sharing a few more pictures from my day… – Julie Cerrone, It’s Just A Bad Day, Not A Bad Life | Facebook

Sharing a few more pictures from my day so far at National Institutes of Health (NIH) at the FDA/CBER Part 15 Public Hearing. My mom sent me the pic of…

Who can say the impact my testimony truly had, but I’ll tell you this.

I don’t feel like I went through all of this for no reason. I feel like I went through all of this because there is a bigger purpose. And if I can use that experience to help just one patient out there, then having gone through it makes it all worth it.

To have people tweeting me during the session saying “thank you for representing us!”, “thank you for being our voice”, “thank you for being there in person when we wish we could be, but are too sick”.

That made it all worth it.

I would pay $1000 to do it over again for those patients.

 

What Now?

So what’s the future of stem cells? I don’t know, your guess is as good as mine. But, I really hope that no one takes the ability away from us to tap into the unique healing ability each and every one of our bodies possess.

Given half a chance our bodies will heal themselves, by themselves. We just have to give them half a chance!

I leave you with a video of my 5 minute testimonial.

Together we can do this. I’m sure of it!

 

Also have to say THANK YOU to the Almanac for covering my story and for my alma mater West Virginia University for writing up a great article on me as well. The B&E post is my favorite one to date!

To check out all the public comments which were made, make sure to click here.

Wishing You A Pain Free Day!

Julie Cerrone | Spoonie, Autoimmune Warrior, Certified Holistic Health Coach, DoTerra Wellness Advocate, 200 RYT Trainee, Reiki 1, Nutrition Geek, ePatient Advocate, IT Consultant, Pittsburgh Based Practitioner Living the Chronic Life

  • Ron Wesselink

    Great going. You are an inspiration. I am in Europe and was going to have stemcell treatment in The Netherlands for my arthrosis but it has been forbidden. Government shut down the clinic a week before it was going to happen. Your testamony should be heared worldwide and you will make the difference for many many people. Thank you from my heart.

    Ron

    • Oh my goodness! What horrible timing – so sorry to hear. I want this type of treatment to be available to everyone. I feel like I have a responsibility to help forge that forward having seen the benefits of stem cells. Thank YOU for your support and for reading!

  • Cathy Chester

    You amaze me every time I read your words and now hear your strong voice at this FDA hearing! You go, girl. You are changing the world for patients and I am so proud of you. Onward and upward, my new friend. So glad you, and the stem cells, brought you to this better place. Hugs.

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  • Sue

    Hi Julie!
    I appreciate your time and advocacy!!!
    I was dx arthritis. I am scared for my future health BC I have so much pain and I am not able to keep up with daily ADLs.

    I have been told Ortho stem cell transplant and PRP could regenerate and rejuvenate my issues. I’m scared BC of the cost.
    I want consult Regenexx dr centeno Colorado.

    May I kindly speak to you.
    I signed up for newsletter.

    I could find your email to connect with you!

    Sue, TX

  • Sue

    Hi Julie,
    Your health hx is amazing!!
    I am so sorry for the pain and suffering you endured. Ty for being a patient advocate by sharing your story and your successful outcomes with the FDA s/p Ortho stem cell transplant. I pray for ins panels to cover this tx someday soon!!!
    God Bless You!!
    Sue, TX