Category Archives: Education

March 10th Webinar: Stem Cells For Multiple Sclerosis

In recognition of Multiple Sclerosis Awareness Month, Celltex is kicking off March with a discussion on symptom and progression management for MS.

Register here: Celltex Stem Cell Webinar March 10th 11:00 AM Central Standard Time
In This Webinar:

  • Updates on the potential cause of MS
  • A look at the damage caused by MS
  • The role that MSCs play
  • Celltex’s retrospective study on MS clients
  • SammyJo’s MS journey & stem cell treatment experience

Join this free webinar to learn about the role that mesenchymal stem cells (MSCs) play in responding to the damage caused by MS. We will be joined by Celltex client SammyJo Wilkinson as she shares her experience with MS and her stem cell advocacy. Dr. Stanley Jones, Celltex Chief Medical Officer, will also join to provide a medical perspective on the properties of MSCs that are particularly promising for managing MS.

Catch up on SammyJo’s advocacy efforts in this recording of her speaking at a 2016 FDA hearing on the regulation of human cells, tissues, and cellular and tissue-based products (HCT/P’s). https://vimeo.com/184351310

♦ Only 4 Adverse Events Reported Against 570 Stem Cell Clinics

A Freedom Of Information Act (FOIA) request to the FDA has revealed only 4 reports of adverse events against a list of 570 U.S. stem cell clinics.

This low number of FOIA reports demonstrate that:

  • There is clearly not an established pattern of harm.
  • There is no significant trend of harm, just fear of harm.
  • Fear of harm is not a basis for crafting health policy. Proof of harm is as essential as proof of safety.

Pervasive hype, both overly positive and overly negative hurts us all. Dr. Feel Good and Chicken Little have no place at the table of social or health policy of such gravity to our lives and the lives of those we love.

Here is the response to the request, followed by links to the 4 reports.

Cc: “ORAHQ ACRA ESS FOI-DISCLOSURE STAFF”
Sent: Monday, August 22, 2016 2:45:07 PM
Subject: FOI Request 2016-6466

8/22/2016

Dear Requestor,
The attached records are being provided by the Office of Regulatory Affairs (ORA)Information Disclosure in response to your request #2016-6466 dated 08/08/16 for records from the Food and Drug Administration pursuant to the Freedom of Information Act regarding:

ADVERSE EVENTS RE CELLULAR THERAPIES

Your request is granted in part.

After a thorough review of the responsive records, we have determined that portions of the documents are exempt from disclosure under FOIA exemptions (b)(4) and (b)(6) of the FOIA 5 U.S.C. § 552, as amended and delineated below:

Exemption (b)(4) permits the withholding of “trade secrets” (TS) and “commercial confidential information” (CCI). Disclosure of this information would impair the government’s ability to obtain necessary information in the future and cause substantial harm to the competitive position of the person from whom the information was obtained. Under the balancing test of this exemption, we are withholding all proprietary information identified as TS and CCI.

Exemption (b)(6) permits the withholding of information which, if released, would constitute a clearly unwarranted invasion of personal privacy. In this case, it was determined that there is no countervailing public interest qualifying under the standard set forth, under exemption (b)(6), to release the personal identifying information of certain third parties.
ORA considers your request closed. If you have any questions about this response, you may contact Anna Postell at 301-796-6488.

Sincerely,
Anna Postell
Program Analyst

These are the adverse event reports:
APPLIED_Consumer Complaint 127882_Redacted.pdf
APPLIED_Consumer Complaint 131004_Redacted.pdf
APPLIED_Consumer Complaint 141021_Redacted.pdf
APPLIED_Consumer Complaint 144501_Redacted.pdf

Note: The request was granted in part, This doesn’t mean there are more than 4 records and the FDA is withholding them. It means the privileged types of information (b)(4) and (b)(6) are not provided, which you can see have been redacted in all of the 4 records.


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Access To Stem Cell Therapy: Progress In 2015

Patients For Stem Cells (PFSC) is a group of patients faced with no-option medical conditions. Many of us have been early adopters of stem cell therapy, and are only here today because it saved our lives. Frustrated by slow adoption in the U.S, we advocate for expedited access. We are very pleased to share with our readers that 2015 has brought watershed changes in legislation that lays the foundation to implement this goal. Leaders in the regenerative medicine field have outlined how access can become a reality. Implementation in on the horizon, and will be in focus at this landmark conference.

The Alliance for the Advancement of Cellular Therapies (AACT), organizer of this event, is a welcome new ally, the bridge between patients, government and regenerative medicine leaders who can finally make real change happen. ACCT is dedicated to the ethical, efficacious, and expeditious advancement of cell therapies.
To help spread awareness and education about cellular therapy, AACT can send a personal conference invite to your doctor, send a request to info@AACT.co

Kathy Hebert

Patients are core stakeholders of ACCT, thanks to President and Co-Founder Kathy Hebert.Her personal experience with life-changing cellular therapies ignited her passion to bring everyone together to achieve the best possible patient outcomes.
For the conference, Kathy has brought together a group of presenters, keynoted by Arnold Caplan,Ph.D. Mark Holterman, MD. Ph.D.ACCT Chairman and Co-Founder, and Paolo Macchiarini, MD, Ph.D

Keynote Speakers

Keynote Speakers

Leading up to the conference we will profile the contributions these luminaries have already made to the lives of patients, as architects of accelerated access, and best in-class clinicians utilizing cell therapy to address difficult disease such as heart failure, auto immune disease, Alzheimer’s, Parkinson’s, osteoarthritis, and more.

Presenters will also include those involved in legislation that swept the nation as 22 states passed “Right To Try” laws for terminally ill patients to access experimental therapies, including biologics like stem cells. Then on July 10th, 2015 the 21st Century Cures Act was approved by the U.S. House of Representatives, also addressing ways to speed regenerative medicine access. Now is the time for us to dive into the details of all these initiatives, and make sure our best interests as patients are met.

A special thank you to Dr. Camillo Ricordi for publishing the Proceedings of the AACT conference in

CellR4

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