Stem Cells on Valentine’s Day: Update on Cardiac Regenerative Medicine

heart stem cellsCan stem cells mend a broken heart?

The idea of the use of stem cells and regenerative medicine strategies for heart disease has taken us on a roller coaster ride over the years.

There are many controversial questions still such as whether the adult heart has meaningful populations of endogenous stem cells. Can administration of stem cells help a damaged heart?

Where do things stand today?

As Deepak Srivastava, cardiac stem cell expert, told in me for a past blog post here, there are endogenous heart stem cells, but probably not in sufficient populations to be clinically significant directly.

Despite the wildness in this area of clinical research for the past 1-2 decades, there are reasons for hope and recent good news. For instance, the field has never had a better understanding of stem cells and the heart.

There are also more than 600 clinical trials listed for the search “heart AND stem cells” on clinicaltrials.gov. Many of these won’t work out, but I’m confidence that quite a few will and could lead to safe and effective new stem cell treatments for the heart. So in the next 5-10 years, I expect we’ll see stem cells mending broken hearts.

Historic Boston Globe editorial on FDA, stem cells & patients argues safety first

For the first time I have ever seen in at least half a dozen years, a major newspaper in the form of The Boston Globe has published an editorial on FDA regulation of stem cells.

Boston Globe

The editorial, entitled “It should be safety-first on stem cell therapies”, argues that while we should take patient concerns into consideration, it must be safety first on experimental stem cell therapies.  I commend them for this editorial and their common sense approach to this hot topic.Stem Cell Medicine

It’s great that the Globe places this opinion in the context of the upcoming FDA public hearing on regulations related to stem cells. The Globe’s opinion carries great weight and appears supportive of the FDA.

The Globe piece closes this way:

“The FDA has scheduled a public hearing on April 13 to solicit comments on draft guidelines it released last fall to clarify the use of stem cells. Under those guidelines, most cells would have to meet the same regulatory standards that apply to drugs. That concerns some patient advocacy groups, including the Alliance for the Advancement of Cellular Therapies and Patients for Stem Cells. They worry about approval procedures that could drag on for years, and they say denying patients control over the use of their own cells amounts to a civil-liberties violation. Those concerns deserve consideration, but patients also need to trust that any treatment they seek from a licensed physician or medical center has passed muster with the FDA. When stem cells are used as medicine, they should be regulated as medicine.”

Kudos.

Video: #CRISPR, designer babies, gene drive, my book & more on TWIS

I had fun doing an interview  on This Week in Science (TWIS) this week with Dr. Kiki Sanders. The video is below.

We talked specifically about CRISPR, designer babies, gene drive, and my new book GMO Sapiens. Check out the book.

TWIS is so awesome and I am now going back to watch their older episodes.

FDA meeting on stem cell regs: mostly who’s who of anti-regulation forces

FDAThe FDA in the past year or so has issued draft guidances on regulation of stem cells that would, if finalized, make it crystal clear that what many American stem cell clinics are selling are unapproved drugs.

That would be a good thing for patients who are often being put at risk by many of the clinics. This is the reality no matter what some of the patient advocates who promote the clinics might say. Such finalized FDA regs that unambiguously state that, for example, fat stem cells are drugs, would be bad news for the clinics that are after patients’ money. Update: It is important to note that not all patients or patient advocacy groups are pro-clinic and anti-FDA. Every patient has a different story and I’ve met many that know the clinics aren’t some kind of Robin Hoods of stem cells.

It is perhaps not surprising then that at the planned upcoming public FDA meeting on stem cell regs in April, there’s going to be a crowd of anti-FDA, anti-regulation forces converging to speak. The agenda of this meeting, with a few notable exceptions, reads like a who’s who of the for-profit stem cell clinic world. I’ve pasted the agenda at the bottom of this post.

An interesting additional factor going on here is that there are some highly respected organizations also coming to the meeting that, reading the tea leaves, are also almost certainly going to advocate that the FDA be less comprehensive in its regulation of stem cells to accelerate translation. For instance, CIRM recently has made some statements about the FDA needing to speed up and maybe not be as strict.

CIRM probably realizes that there will be many folks at this FDA meeting who have no particular interest in participating in the standard FDA approval process at all. These stem cell clinic folks may cheer on statements from CIRM, if such are made, that come off as wanting a weaker FDA regulatory sphere for stem cells. I cannot imagine that CIRM would want that and I know that CIRM does not support these clinics.

As a result, there’s a vital need for CIRM to choose its approach to this meeting very carefully and cautiously. It may be a fine tightrope to walk. Accelerating evidence-based treatments based on stem cells is one thing, but weakening much-needed regulatory oversight that leads in the near future to clinics taking more money from more patients that they put at risk is quite another.

In short, CIRM’s agenda is very different than that of the clinics. Yet the stem cell clinic crowd could even be hoping to use CIRM’s words at this meeting for their own future publicity. They might even try to get their picture taken with CIRM staff to use on their websites. Historically the stem cell clinics have been very anti-CIRM, but that doesn’t mean that they won’t pounce on a PR opportunity if it arises.

The Alliance for Regenerative Medicine (ARM), which has done and continues to do amazing things, is also likely to push for a relatively more permissive stem cell regulatory construct at this meeting too. I hope that they are cautious not to align themselves with the dubious clinics. The membership of ARM consists of good citizens of the stem cell and regenerative medicine biotech community who work with the FDA and follow regs. This is a night and day difference from the stem cell clinics.

Regardless of how this meeting plays out, it will be fascinating to see and hear the views at this unprecedented gathering.

The agenda as of Feb. 10.

Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products Part 15 Public Hearing Draft Agenda April 13, 2016 FDA White Oak Campus 10903 New Hampshire Ave, Building 31, Room 1503, Great Room Silver Spring, Maryland 20903

8:00-8:15 AM: Presiding Officer Opening Remarks and Introduction of Panel Members 8:15-9:46: Session 1 • 8:15-8:18: Allosource • 8:19-8:22: Atlanta Medical Center • 8:23-8:26: AZ Pain Centers • 8:27-8:30: Birth Tissue Recovery, LLC • 8:31-8:34: California Stem Cell Treatment Center and Cell Surgical Network • 8:35-8:38: CAREStream America • 8:39-8:42: Celebration Stem Cell Center • 8:43-8:46: Centeno-Schultz Clinic • 8:47-8:50: Harvard Apparatus Regenerative Technology • 8:51-8:54: INCELL Corporation LLC • 8:55-8:58: Intellicell BioSciences • 8:59-9:02: Johnson & Johnson • 9:03-9:06: LifeLink Tissue Bank • 9:07-9:10: LifeNet Health • 9:11-9:14: Long Island Plastic Surgical Group • 9:15-9:18: MedCentris • 9:19-9:22: Info Health Global • 9:23-9:26: Millennium Medical Technologies • 9:27-9:30: MiMedx Group, Inc. • 9:31-9:34: Minnesota Medical & Rehabilitative Services • 9:35-9:38: Musculoskeletal Transplant Foundation • 9:39-9:42: National Spine & Pain Centers • 9:43-9:46: Oregon Regenerative Medicine 9:47-9:55: Questions from panel 9:55-10:25 Break 10:25-11:56: Session 2 • 10:25-10:28: Organogenesis Inc. • 10:29-10:32: RTI Surgical • 10:33-10:36: StemGenex, Inc. • 10:37-10:40: U.S. Stem Cell Inc. (FKA BIOHEART Inc.) • 10:41-10:44: Robert W. Alexander, M.D. • 10:45-10:48: Scott R. Graham, M.D • 10:49-10:52: Shay Bess, M.D. • 10:53-10:56: Julie Cerrone • 10:57-11:00: Ann A. Connolly • 11:01-11:04: Shawn Connolly • 11:05-11:08: Elio Coradin • 11:09-11:12: Terri Coutee • 11:13-11:16: Charles S. Cox, Jr., M.D. • 11:17-11:20: Pamela Fricke • 11:21-11:24: Brian Gates • 11:25-11:28: Jarvis P. Green • 11:29-11:32: Candace Hart • 11:33-11:36: David Jacobs, M.D. • 11:37-11:40: Carolyn M. Salafia, M.D. • 11:41-11:44: George U. Sauter • 11:45-11:48: John Klimkiewicz, M.D. • 11:49-11:52: Samantha Wilkinson • 11:53-11:56: Rebecca Baergen, M.D. 11:56-12:00 Questions from panel 12:00-1:00: Lunch: Ala Carte items will be available for purchase on site 1:00-1:35: Session 3 • 1:00-1:03: MaryAnn Chirba, J.D. • 1:04-1:07: Case Western Reserve University • 1:08-1:11: Indiana University School of Medicine • 1:12-1:15: Wake Forest University School of Medicine • 1:16-1:19: Navigant Consulting • 1:20-1:23: OrthoKinetic Technologies, LLC • 1:24-1:27: Parenteau BioConsultants • 1:28-1:31: Alston & Bird LLP • 1:32-1:35: Topher Stephenson, M.D. 1:36-2:52: Session 4 • 1:36-1:42: Alliance for Regenerative Medicine • 1:43-1:49: Alliance of Wound Care Stakeholders • 1:50-1:56: American Association of Tissue Banks • 1:57-2:03: Bipartisan Policy Center • 2:04-2:10: California Institute for Regenerative Medicine • 2:11-2:17: Coalition of Wound Care Manufacturers • 2:18-2:24: Curemonos • 2:25-2:31: Foundation for the Accreditation of Cellular Therapy • 2:32-2:38: International Society for Cellular Therapy • 2:39-2:45: National Center for Health Research • 2:46-2:52: Patients for Stem Cells 2:52-3:00: Questions from panel 3:00-3:30: Break 3:30-4:53: Session 5 • 3:30-3:36: The Amputee Coalition • 3:37-3:43: The Cord Blood Association • 3:44-3:50: The Cure Alliance • 3:51-3:57: Academy of Regenerative Practices • 3:58-4:04: Alliance for the Advancement of Cellular Therapies • 4:05-4:11: American Association of Neurological Surgeons and Congress of Neurological Surgeons • 4:12-4:18: American College of Surgeons • 4:19-4:25: American Society of Plastic Surgeons • 4:26-4:32: Biologic Orthopedic Society • 4:33-4:39: International Cellular Medicine Society • 4:40-4:46: International Federation for Adipose Therapeutics and Science • 4:47-4:53: The Plastic Surgery Foundation 4:53-5:00: Questions from panel 5:00-Close: Closing statement from Presiding Officer

Enter Fun CRISPR Backronym Contest: $50 Prize

CRISPR backronym contestUpdate: you can also enter our contest on Twitter using the hashtag #CRISPRback.

Do you like contests, words, science, and cash?

Enter our new contest.

It’s a backronym contest for CRISPR.

The author of the best backronym will win a $50 prize paid by me and fame of course as the winner.

The judges will be WSJ columnist Ben Zimmer, Senior Editor at MIT Tech Review Antonio Regalado, and myself.

A backronym is like an acronym, but flipped around in the sense that you choose words to fit the existing letters that together make up an existing acronym word. For more backronym background check out Ben’s recent excellent piece on CRISPR.

Wikipedia lists some funny examples including NASA’s COLBERT treadmill and Arby’s creating “Amerca’s Roast Beef, Yes Sir!” after it already had the name Arby’s, chosen for some other reason.

CRISPR is already an acronym for Clustered Regularly Interspaced Short Palindromic Repeats.

But that’s a mouthful, not very fun and tough to try to remember.

So what if CRISPR didn’t really stand for those complicated words “Clustered…etc etc”? What if each word of CRISPR was memorable and together they made some interested meaning?

In that spirit, make a backronym for CRISPR by choosing clever new words for C, R, I, S, P, and R.

For instance, as a backronym CRISPR could stand for one of these:

  • Creative Reinterpretations In Scientific Public Relations
  • Can Researchers Initiate Sane Patent Rules

Update: Or it could be something more scientific.

Fire away by sending your CRISPR backronyms to me at [email protected] or leaving them here on this blog post as a comment. The backronym entries must be original and not offensive.

The deadline is a week from today on February 15th at midnight pacific time.