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Thread: My COPD success with Stem Cells now taken away by FDA

  1. #1

    Default My COPD success with Stem Cells now taken away by FDA

    My COPD success with Stem Cells now taken away by FDA

    Stem Cells Work! If you are interested in the Right to use your own stem cells to heal, please read.

    My Story

    I’m a 67 year old man. I’ve been a highly active person all my life. I regularly enjoyed racing cars, mountain bike riding, hiking, snow skiing and much more. Then, in my 50’s I started having trouble breathing. I found myself cutting out the activities I loved because I couldn’t catch my breath or I got lightheaded at altitude or I’d wear myself out and have to rest for days as my body recovered from activities that were suddenly too strenuous for me to participate in. After about two years of it getting progressively more difficult to breathe, I went to see a pulmonologist and was diagnosed with COPD (Chronic Obstructive Pulmonary Disease).

    The pulmonologist advised that nothing could be done to repair or cure my condition, that I should expect it to continue worsening over time and then prescribed me three steroids to take for short-term breathing assistance: Symbicort, Spiriva and Tudorza. Discouraged, I talked to my General Practitioner who advised that COPD could only be reversed with Stem Cells. Back to the Pulmonologist I went with this information, but the Pulmonologist said Stem Cells were “crockery – a waste of time and money” and “keep inhaling the steroids”.

    In June of 2015, I went to US Stem Cells in Florida for my first adipose treatment. The results were astounding. Within a couple weeks, I could walk up stairs and hike up hills without the need to stop and catch my breath. Since then, I have received four additional treatments and each time my breathing has gotten noticeably better. I am back to riding my mountain bike, back to racing cars, back to snow skiing without dizziness from the altitude, back to scuba diving, and so importantly, back to participating in family activities on a regular basis.

    There has been no need to use steroids since my very first Stem Cell treatment and my COPD has not progressed at all. In fact, my breathing has improved each and every time I’ve received a treatment from US Stem Cells and I am drug-free! Stem Cells are not a drug; they are taken from my body. I have no side effects, and the cost of Stem Cell treatments is very reasonable given the huge benefit.

    Why I chose US Stem Cell Clinic
    Prior to my treatment at US Stem Cell I spent a lot of time on Stem Cell Pioneers Forum plus researching and talking to different clinics. Most of the clinics administer a single dose of adipose or venous stem cells and some charge a lot of money. At US stem cell the first adipose treatment was less than other clinics and my four follow up treatments were less than the cost of the airfare for my wife and I to fly from California to Florida.

    Prior to my treatment, I had a couple long conversations with Kristin Comella, who is US Stem Cell’s Chief Scientific Officer. She was very knowledgably, informative and caring. Kristen was ranked 24th on Terrapin’s Top 50 Global Stem Cell Influencers and number 1 on the Academy of Regenerative Practices list of Top 10 Stem Cell Innovators. I was also able to talk with US Stem Cell patients that had received Adipose treatments and their positive results were encouraging.

    Now it is being taken away from me and others
    On June 6th US Stem Cell Patients received notice that they would no longer have access to their own Stem Cells. The FDA’s suit in Federal Court claiming that Adipose stem cells removed from and re-administered into the same person should be considered a drug was upheld in Federal Court and the FDA was granted an injunction.

    Common sense supports the fact that these are our cells and not a drug. US Stem Cell has argued that the SVF surgical procedure is exempt from FDA regulation and is subject to each state's authority to regulate the practice of medicine, yet the federal district court hearing the case entered an order upholding the FDA’s position that our cells are a drug and subject to Federal oversight and regulation.

    In 30 days my banked Stem Cells will be destroyed
    On June 28th, US Stem Cell Patients were informed that U.S. District Judge Ursula Ungaro of the Southern District of Florida issued an Order and Injunction that generally prohibits US Stem Cell, Inc., US Stem Cell Clinic, LLC and others from receiving, processing, and distributing SVF Product, among other actions. This Order also requires that “Within thirty (30) calendar days after the entry of this Order, Defendants, under FDA's supervision, shall destroy any and all SVF Product that is in Defendants' possession, custody, or control."

    US Stem Cell has treated over 7,000 patients and two or three patients have had adverse reactions. The vast majority, like myself, have had excellent results after being told by conventional medical Doctors nothing could be done. US Stem Cell currently has cells banked for over 5,000 clients. The FDA is through court action, forcing US Stem Cell to stop treating patients with Adipose stem cells and is requiring that the banked cells of 5,000 clients be destroyed. This is devastating news to me and the other Stem Cell Patients that have a renewed quality of life after standard medicine has failed us.

    According to a recent comprehensive study conducted by Johns Hopkins Hospital, more than 250,000 people in the United States die every year because of medical mistakes. Other reports claim the numbers to be as high as 440,000. Preventable Medical errors in the United States are now the third leading cause of death after heart disease and Cancer. And yet, low-cost low-side-effect stem cell treatments for patients with chronic illness having success outside the Pharmaceutical pillbox are being targeted by the FDA.

    Why would the FDA want to stop a relatively inexpensive treatment that is statistically beneficial and has much less potential for side effects than standard medicine?
    Many think it is because of their ties to the Pharmaceutical Industry. Scott Gotleib stepped down as FDA Director in April and last month it was announced that he is joining the Board of Directors of the Pharmaceutical giant Phizer. The Pharmaceutical Companies fund 45% or 2.4 Billion of the FDA annual budget. Pharmaceutical companies spend more on Lobbying than any other industry and donate millions to Politicians. In the 2018 Election cycle Pharmaceutical companies spent over $300 million on Lobbying and Political Donations. 11 of 16 FDA medical examiners who worked on 28 drug approvals and then left the FDA for new jobs are now employed by or consult for the companies they recently regulated. This revolving door can create at least the appearance of conflicts of interest. More than a quarter of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies, according to research published by a prominent medical journal. There is more money in Sickness than in Health! It is more profitable to treat a chronic illness than it is to cure it.

    As it stands now (Patients Fight Back for our Rights)
    Two attorneys, representing groups of patients (myself included), filed motions to stop the court and the FDA from destroying our banked stem cells based on the premise we were not privy to or named in the lawsuit to destroy our cells. On July 19th, the court upheld the motion so for the time being the cells are safe. For now, the court recognizes that the patients and owners of the stem cells have a right to be heard before our cells are destroyed.

    What Can You Do To Help

    Petition was initiated by Lori Martin Gregory of The Mom Street Journal

    Write Letters to: Let them know our stem cells are not a drug and belong to us.
    US Department of Justice
    Civil Division
    950 Pennsylvania Avenue, NW
    Washington, DA 20530-0001

    Ariana Fajardo Orshan
    US Attorney for Southern District
    99 NE 4th Street
    Miami, FL 33132

    US Senator Marco Rubio
    201 South Orange Avenue, Suite 350
    Orlando, FL 32801

    Clerk of the Court/US District Court
    400 NW 1st Avenue
    Miami, FL 33030

    Please be sure to include this reference in every letter: USA v US Stem Cell Clinic, Case 18-CV-61047-UU

    Please also write to your Senators and Representatives.

    (Example) Included in my letter to the US Attorney for Southern District
    July 9, 2019

    Ariana Fajardo Orshan
    US Attorney for Southern District
    99 N.E. 4th Street
    Miami, FL 33132

    Re: USA v US Stem Cell Clinic and others, Case 18-cv-61047-UU

    My contract with US Stem Cells clearly states that I am the owner of my stored Stem Cells at the US Stem Cell facilities. I paid for the removal procedure and storage of the cells. The Court has ordered that my stored Stem Cells be destroyed by July 25th. However, I was not a party to Case 08-cv-61047-UU, and have had no due process or opportunity to be heard regarding my claim to my cells – my property. I am due this right. Please stop the destruction of my cells before they are lost to me.

    I strongly disagree with the outcome of USA v US Stem Cell Clinic and others, Case 08-cv-61047-UU. Stem Cells are not a drug and they should not be under the control of the FDA. They are my cells, they are taken from my body, they provide great relief from my breathing ailment, and they have no side effects. They are a part of me, and they belong to me.


    Paul D*****

    Informative Links
    My Cells My Choice

    The David Knight Show. Youtube video with Kristin Comella of US Stem Cell

    FDA vs YOUR Body, YOUR Choice

    Stem Cell Strides Facebook page Let them know if you have been positively impacted with Stem Cell Therapy

    U. S. vs Dr. Kristin Comella

    Mel Gibson talks about his Dad’s and his own Stem Cell Success

    Kristin Comella Interview

  2. #2


    Thank you Paul for this information. Members - Please sign the petition, and help Paul and others involved in this case by simply following his instructions on who to send a respectful message to about this case. I also would ask that his post be shared on any social media sites that anyone belongs to. Post this link to such sites:

    I have fought for our right to our own stemcells and right to therapy for over a decade now. It is truly incredible when the media, academia, Big Pharma and the judicial system, not to mention the FDA, believe that we have no such rights and that we are unable to make our own health care decisions. This has been going on far too long.

    The results that Paul (and others) experienced have improved his life so much and yet in a quick decision to be made by a judge who probably has no scientific or medical training, he could be back to square one. Let's get behind this members and readers and do what we can to shine light on this case. These are the patient's own stemcells. They belong to them, no one else.
    First treatment in 2007. Pioneering ever since.


  3. #3

    Default Update

    First treatment in 2007. Pioneering ever since.


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