Pfizer Dumps Stem Cell Therapy From Its Portfolio

By Chris Centeno, MD /

Receive a Regenexx® Patient Info Packet by email and learn why it's a superior regenerative solution.

mass manufactured stem cell therapy

There was big news this week in the world of cellular drugs. One of the world’s largest pharma companies chose to drop it’s FDA approval pipeline for cell drugs. Let’s explore the top three reasons why.

Pfizer had partnered with a company called Athersys who has a culture expanded mesenchymal stem cell product called Multistem. This is an off the shelf stem cell therapy in a vial made from other people’s cells. IMHO, the top three reasons why this type of cell therapy didn’t make it were 1. profit over efficacy, 2. hyper-regulation, and 3. hype.

On the profit over efficacy front, I’ve blogged before on the problems with companies like Athersys. Caught up in trying to convince a company like Pfizer that cells could have pennies a dose manufacturing costs like chemical drugs, they participated and were one of the worst companies in the dosing arms race. This is where various companies each began claiming that they could grow more stem cells from a single donor than the last. At first it began in the thousands of doses, then it jumped to tens of thousands, then hundreds, and finally millions of doses. Athersys on their web-site still claims that Multistem has “Large scale production potential (e.g., millions of doses from each donor)”. Anyone who has ever been involved in the actual use of culture expanded stem cells clinically knows this number is crazy, in fact, a thousand doses is pushing reality. If Athersys or anyone else is actually getting 1,000,000 doses of cells from a donor, those cells are not helpful to patients. However, apparently Pfizer bought this hook line and sinker and realized it’s fatal error too late.

In the same category as ridiculous dosing numbers is the “allo” problem. Companies like Athersys, again to convince big pharma that cells could be made and used like drugs (rather than cells) have overlooked the mounting science that cells from another person still cause certain parts of the host’s immune system to activate, killing the transplanted cells. The company does seem to finally acknowledge this, but in code on their website in that they state “Not a permanent transplant – cells cleared from the body over time (like a drug)”. To the casual investor without a knowledge of how cells work, this statement might seem to make Multistem incredibly attractive. To anyone with more knowledge, it means, “we know that our cells are killed off by the host’s immune system and aren’t around for long, but we’re trying to make lemons look like lemonade”.

You can’t look at an autopsy of the death of the Athersys-Pfizer partnership without discussing regulation. The USFDA and now the EMA have both decided that many types of cell therapy should be regulated the same as chemical drugs. This has added a gigantic cost burden to the use of stem cells to help patients. While the cell therapy industry has argued until they’re blue in the face that this is the right move, many others have argued it’s the wrong move. In fact, without the financial muscle of huge pharma companies like Pfizer, the costs of FDA approval go from simply a market barrier to entry, to a crippling albatross.

Finally, the hype machine created around embryonic stem cells is partly to blame for the death of this partnership. Due to the religious right’s opposition to anything embryonic, to gain public support for their research, scientists created a marketing machine of professional groups second to none. They convinced the public and then investors that stem cells were magical and could cure everything known to man, rather than a great tool, useful to help patients in certain circumstances. Add in the pandering to big pharma as discussed above and the high cost of the regulatory burden and rather than cells being helpful tools, stem cells had to perform like magic fairy dust by making the blind see and the crippled walk to get insurance companies to want to pay the high price of admission. In the end, it looks like Pfizer finally realized that someone else’s stem cells in a vial weren’t performing like magic.

The upshot? As I’ve warned before, be very wary of investments in mass manufactured stem cell therapy drug companies. While a few will become the household names of the future and do quite well because they are focusing on low cost technologies or do have home run applications, most will fail miserably like Athersys for the reasons above.

Category: Latest News

Chris Centeno, MD

Regenexx Founder

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications.
View Profile

Get Blog Updates by Email

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Regenerative procedures are commonly used to treat musculoskelatal trauma, overuse injuries, and degenerative issues, including failed surgeries.
Select Your Problem Area
Shoulder

Shoulder

Many Shoulder and Rotator Cuff injuries are good candidates for regenerative treatments. Before considering shoulder arthroscopy or shoulder replacement, consider an evaluation of your condition with a regenerative treatment specialist.

  • Rotator Cuff Tears and Tendinitis
  • Shoulder Instability
  • SLAP Tear / Labral Tears
  • Shoulder Arthritis
  • Other Degenerative Conditions & Overuse Injuries
Learn More
Cervical Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Knee

Knees

Knees are the target of many common sports injuries. Sadly, they are also the target of a number of surgeries that research has frequently shown to be ineffective or minimally effective. Knee arthritis can also be a common cause for aging athletes to abandon the sports and activities they love. Regenerative procedures can be used to treat a wide range of knee injuries and conditions. They can even be used to reduce pain and delay knee replacement for more severe arthritis.

  • Knee Meniscus Tears
  • Knee ACL Tears
  • Knee Instability
  • Knee Osteoarthritis
  • Other Knee Ligaments / Tendons & Overuse Injuries
  • And more
Learn More
Lower Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Hand & Wrist

Hand & Wrist

Hand and wrist injuries and arthritis, carpal tunnel syndrome, and conditions relating to overuse of the thumb, are good candidates for regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Hand and Wrist Arthritis
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Thumb Arthritis (Basal Joint, CMC, Gamer’s Thumb, Texting Thumb)
  • Other conditions that cause pain
Learn More
Elbow

Elbow

Most injuries of the elbow’s tendons and ligaments, as well as arthritis, can be treated non-surgically with regenerative procedures.

  • Golfer’s elbow & Tennis elbow
  • Arthritis
  • Ulnar collateral ligament wear (common in baseball pitchers)
  • And more
Learn More
Hip

Hip

Hip injuries and degenerative conditions become more common with age. Do to the nature of the joint, it’s not quite as easy to injure as a knee, but it can take a beating and pain often develops over time. Whether a hip condition is acute or degenerative, regenerative procedures can help reduce pain and may help heal injured tissue, without the complications of invasive surgical hip procedures.

  • Labral Tear
  • Hip Arthritis
  • Hip Bursitis
  • Hip Sprain, Tendonitis or Inflammation
  • Hip Instability
Learn More
Foot & Ankle

Foot & Ankle

Foot and ankle injuries are common in athletes. These injuries can often benefit from non-surgical regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Ankle Arthritis
  • Plantar fasciitis
  • Ligament sprains or tears
  • Other conditions that cause pain
Learn More

Is Regenexx Right For You?

Request a free Regenexx Info Packet

REGENEXX WEBINARS

Learn about the #1 Stem Cell & Platelet Procedures for treating arthritis, common joint injuries & spine pain.

Join a Webinar

RECEIVE BLOG ARTICLES BY EMAIL

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Subscribe to the Blog

FOLLOW US

Copyright © Regenexx 2019. All rights reserved. | Privacy Policy

*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.