DAVID GRANOVSKY

MEDICAL BOARD Gives Early OK to Adult Stem Cell Rules – Part 1

In VICTORIES & SUCCESS STORIES on April 8, 2012 at 8:55 pm

HUGE NEWS! WHAT THIS MEANS:

  • You can get stem cells in Texas.
  • They have to tell you they are not approved by the FDA.
  • They have be reviewed by an IRB – Institutional Review Board.

Medical Board Gives Early OK to Adult Stem Cell Rules

by Gerald Rich – February 10, 2012

After months of deliberation — and input from Gov. Rick Perry, among others — the Texas Medical Board on Friday gave preliminary approval to a set of rules on adult stem cells in Texas that are less stringent than those originally proposed.

With no opposition, the vote on a topic that has received much scrutiny and skepticism since last spring took only about five minutes.

“It’s been a delicate balance between our absolute goal to protect the public and at the same time [our] desire not to stifle what we feel will be a huge boon to medicine,” said Dr. George Willeford, a member of the board. “Perhaps we’ve been criticized by the media for taking a middle road, but [the middle road] was absolutely necessary.”

In the weeks leading up this meeting, members of many Texas academic institutions had written to the Board to express concern that the rules — “Standards for Use of Investigational Agents” — were too restrictive and created what they felt might be onerous regulations on any treatment that could be undergoing clinical trials.

Discussion of changing the Texas Administrative Code to include regulating these trials began last summer after Perry used adult stem cells to treat a recurring back injury. Perry learned of and advocated for the treatment after Dr. Stanley Jones — a Houston orthopedist, donor and personal friend of the governor — flew to Japan to receive the same treatment for his arthritis.

At the moment, extracting, growing and using adult stem cells is considered largely experimental and can cost anywhere from $10,000 to $50,000. However, those at the meeting expressed hope that this new treatment could eventually become affordable and accessible to more Texans.

Under the rules OK’d on Friday, patients will be informed that using adult stem cells, or any investigational agent, has not been approved by the FDA and that any clinical trials will be approved and overseen by an Institutional Review Board, or IRB.

The board and industry leaders hope this new rule will give them more data on the potential benefits of using adult stem cells. Currently, there is no substantial data to indicate that adult stem cells are beneficial for patients other than those undergoing bone marrow transplants — used for decades to treat leukemia and sickle cell anemia.

In late August, the board’s initial rule had included language requiring consent forms detailing the risks and benefits, and stating that any treatment offered needed to have a favorable risk/benefit ratio.

Now that the proposed change has been approved by the board, the rule will be printed in the Texas Register, where the public can view them and comment on them. Further drafts of the rule may be drawn up, with the final version put to vote for adoption during the April board meeting.

“Some language was removed and some was added,” said Mario Salinas, director of Texans for Stem Cell Research. “Patients are going to be informed as to [the] pros and cons that will ensue from being in a clinical trial. Whatever language was deleted was made better with the new language that was added.”

Glenn McGee, president of strategic initiatives for Houston-based Celltex Therapeutics — which was founded by Jones and Perry donor David Eller, and is a Texas adult stem cell bank — was also in attendance Friday and happy with the proceedings.

“Texas decided, unlike anyone else in the country or anyone in the world, to take a position on how to think about stem cells and the practice of medicine,” McGee said. “I think Texas will become the source for articles about adult stem cell use in peer reviewed articles.”

Editor’s note: An earlier version of this story incorrectly reported that Celltex Therapeutics was the only Texas adult stem cell bank.

Read more: Medical Board Gives Early OK to Adult Stem Cell Rules — Health Reform and Texas | The Texas Tribune.

Related article: http://repairstemcell.wordpress.com/2012/04/08/medical-boards-proposed-stem-cell-policy-under-fire-part-2/
Background History: http://repairstemcell.wordpress.com/?s=perry

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