Beware of the Fat Stem Cell Research Shuffle!

by Chris Centeno, MD /

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fat stem cell research

This weekend, after spending Saturday teaching a stem cell harvest course for the Interventional Orthopedics Foundation (IOF), I chose a stem cell clinic website from the Internet and looked at the research page. Having reviewed many of these sites before, it was no surprise that the research listed was mostly an illusion. What do I mean?

When patients and physicians hear the term “stem cell,” they have some sense of what that means. However, what many may not know is that there are many different stem cell types and mixes. In fact, some of these may have little in common with each other. Many fat stem cell clinics, seemingly oblivious to these facts, insert research on their websites that has little to do with the procedures they offer.

A Stem Cell by Any Other Name?

In the class I taught this weekend, many physicians were confused by the concept that the properties of a certain stem cell type may not apply to what they want to use on their patients in the clinic. In essence, despite having more education on the topic than the average patient, they were falling into what I call the stem cell research shuffle.

First, to comprehend this problem, you need to understand that most of the stem cell research that you can find published today in the U.S. National Library of Medicine (the single biggest source of medical research data) was conducted with isolated and culture-expanded stem cells. What does that mean?

Culture expansion is a process that starts with a stem cell source, like bone marrow or fat. The starting material for both of these tissues is a complex mix of many, many different cell types with the minority of the cells being considered a stem cell. The process then selects mesenchymal stem cells (MSCs) out of that mix by encouraging those to stick to a plastic surface, while the other cells can’t stick. This is an isolation step where many other cell types are discarded (including a good number of “nonadherent” stem cells of a different type). Once the MSCs are isolated, then more copies of those cells are grown under ideal conditions in the lab. These great growing conditions (perfect temperature, humidity, lots of food, wonderful growth factors) likely change cells every so slightly. So what exits this process (isolated and culture-expanded MSCs) bears little resemblance to the raw mix of cells that entered it.

How Do Culture-Expanded Cells Differ from Raw Cell Mixes?

The culture-expanded cells above are dramatically different in cell content and properties from the “raw cell mixes” used by almost all US stem cell clinics. Almost all of these clinics use either stromal vascular fraction (SVF) from fat or bone marrow concentrate (BMC).

SVF and BMC are raw cell mixes that have more non-stem-cell components than there are MSCs. In addition, they have non-MSC stem cell types as well as many other cells. Hence, they bear little resemblance to culture-expanded MSCs.

The research-shuffle problem is the most severe in the world of same-day fat stem cell procedures known as SVF. This is because we have little data that SVF is helpful for the vast majority of conditions for which it is offered. However, you can usually find research papers on isolated and culture-expanded MSCs for these conditions. So clinics perform a little research sleight of hand by hoping that you won’t notice that the papers they list on their websites used a different stem cell type than the one you’ll get injected into your veins at the clinics.

Just How Bad Is the Research Shuffle?

The clinic website I chose to check this weekend could have been any number of US-based clinics offering same-day fat stem cells (SVF). I went to their “Research” page. Given that none of the research listed was published by the clinic (very common), the page existed for only one purpose—to give a veneer of credibility to their claims that stem cells could help cure or mitigate many diseases. So how thick was that veneer? Paper thin…

The research page listed research on many diseases: degenerative disc disease; chronic obstructive pulmonary disease (COPD); congestive heart failure (CHF); amyotrophic lateral sclerosis (ALS); stroke; spinal cord injuries; rheumatoid arthritis; orthopedic issues, like arthritis; kidney disease; multiple sclerosis; diabetes; Parkinson’s disease; macular degeneration; and traumatic brain injury. Yikes! Given that each of these listed diseases has many subtypes, some of which bear no resemblance to the other, the clinic is really discussing some 30 to 40 similar to different disease states.

The clinic then listed 54 different studies in support of the concept that the SVF that it primarily offered could help these diseases. There was just one little problem. A whopping 94% of the research listed was not conducted using the fat-derived SVF that the clinic uses, but instead mostly with culture-isolated and expanded bone marrow stem cells! In addition to the mix of raw SVF cells being totally different from expanded stem cells, fat and bone marrow MSCs are different cells with different properties. I’ve blogged on this fat versus bone marrow stem cell dichotomy with regard to orthopedic use.

How Many of the Diseases Listed Have Evidence That SVF Will Work?

Given that the research page was a big disappointment at best and likely fraudulent at worst, I then decided to go the other way in my investigation. How many of the diseases listed have some evidence that SVF will be effective? I searched the U.S. National Library of Medicine online PubMed system for the bare minimum of scientific evidence that SVF would be effective. The criteria was that at least one or two animal studies existed where SVF was used and found to effective and at least a small human-case-series was found that showed promise.

Here’s what I found:

do fat stem cells work

Given that only 3 of the 15 indications listed had even minimal research that would allow SVF to be used in an investigational setting, it’s no wonder the clinic substituted research that had nothing to do with what it was offering! When reality doesn’t work, substitute fiction.

The upshot? Don’t get fooled by the stem cell research shuffle! While the use of bone marrow concentrate to treat orthopedic conditions is well established via animal models and patient-case-series data, the use of fat cells to treat a panoply of diseases is poorly established or nonexistent in most instances. Hence, fat stem cell clinics offering to treat a wide variety of diseases often “fudge” the fat stem cell research!

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10 thoughts on “Beware of the Fat Stem Cell Research Shuffle!

  1. Michael More

    Hello, I am a VERY satisfied patient that had the three step bone marrow stem cell treatment for my knee and lower back.

    All I’m commenting here, is requesting that you use a more “readable” typeface in your reports like these. They’re almost light grey and a bit difficult to read.

    It’s a very simple fix. Thank you, Michael More

    1. Regenexx Team

      Michael,
      Glad you’re doing well! This is not the first time we’ve heard that request, so therefore it is not just my eyes! I can make the request…

  2. Lee Hoepfinger

    Is there any time horizon when culture expanded msc will be allowed in the US? What will it take for the FDA to allow same?

    1. Regenexx Team

      Lee,
      We don’t have any updates on that issue, but doubt they will change direction on that as they are busy in the opposite direction: http://www.anh-usa.org/fda-your-own-cells-are-a-drug/

  3. Jim Herman

    Is it my understanding that culture expanded MSC is NOT allowed in the US? Re:response to Lee Hoepfinger’s question.

    1. Regenexx Team

      Jim,
      Culture expanded MSC’s are not allowed in the US at this time. The reply to Lee referred to the fact that the FDA is not likely to change that decision, and that currently they are trying to make the case that adipose stem cells are more than minimally manipulated.

  4. Carol Metral

    Is there any advantage to adding SVF to BMC for use in knees?
    What is Regenexx position on using a mixture of both for orthopedic interventions?
    .

    1. Regenexx Team

      Carol,
      We did extensive testing on adding Regenexx AD (fat) to Our Regenexx SD procedure and found no additional benefit as detailed in this paper we published in 2014: http://www.regenexx.com/blog/we-publish-the-worlds-largest-paper-on-knee-arthritis-and-stem-cells/ We do use Regenexx AD for very specific applications when needed.

  5. Carol

    Could you elaborate on the very specific applications for using Regennexx AD?

    1. Regenexx Team

      Carol,
      The most common is a buttressing a displaced meniscus with a stem cell containing fat graft: http://www.regenexx.com/blog/another-torn-knee-meniscus-helped-by-stem-cells/

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.
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