Fact check: Lung Health Institute & cell therapies for lung disease

What should we make of clinics like the Lung Health Institute? These clinics sell unproven stem cell or regenerative therapies for lung disease. Overall, I’m extremely skeptical. I don’t believe it’s worth the cost. There are also going to be potentially serious health risks. Lung disease is a broad category including COPD, emphysema, pulmonary fibrosis, and other conditions. One product is extremely unlikely to help all of these.

This post is a review and fact-check of the biomedical offerings in this area including especially from the Lung Health Institute.  I’ve also added some background and thoughts on lung stem cells more generally. You can jump down if you wish by clicking on specific topics below.

What’s in this article?

Lung stem cell research & organoids  |  Stem cells for lungs? | Lung Health Institute | What does Lung Health Institute sell now? |  Are platelets a type of cell?  |  Fact-checking PRP for lung disease  |  Literature on PRP for COPD or other lung disease?  | Stem cells for COPD and other lung disease?  | Studies on stem cells for lung disease Lung Health Institute Cost $5,000-$7,000  |  Who owns Lung Health Institute?  |  Looking Ahead |  References

Quick Article Summary and Claim Review. Stem cells and other cell therapies are a still unproven approach to chronic lung diseases like COPD, emphysema, and pulmonary fibrosis. The Lung Health Institute claims that their cellular therapy approach yields real results for patients with lung disease. My research suggests there is little in the way of good published data to support this claim. As a biologist, I also have concerns about the claimed rationale of this approach. There are definite risks too and the procedures are expensive. You should consult your doctor, preferably a pulmonologist. More broadly, the American Lung Association and other organizations recommend against stem cells for lung disease at this time.

You can watch a video summary of some parts of this post on our Stem Cell Channel on YouTube below. Please subscribe!

Lung stem cell research & organoids

Let’s start this by asking, “do adult lungs have their own populations of stem cells?”

lung stem cells, lung health institute
“Mouse (left) and human (right) large lung organoids have multiple types of cells including type 1 (red) and type 2 pneumocytes (green). Images credit: led by Edward E. Morrisey, PhD” Condensed material from Penn.

For a long time researchers found that stem cells were elusive in mature lungs.

There was debate about whether they even existed.

Now it seems fairly established that there are some stem and precursor cells in there. See also this NEJM overview.

But are there enough to make a meaningful difference in endogenous injury repair? Endogenous just means your own cells already in your body. It’s hard to say, but I predict there is some repair that can go on, especially earlier in life. It’s just that with repeated or severe injure the repair systems likely get overwhelmed and then exhausted. At some point there may no more meaningful repair.

Note that one of the early papers on purported human lung stem cells came from Piero Anversa and has been retracted. However, I still think at some a small population of stem cell cells likely exists. Other groups beyond Anversa’s have reported on their existence too.

Also, on a related note, several teams have found that lung organoids can be grown from stem and progenitor cells, which is a powerful relatively new tool. This technology also bears on COVID-19 research.

You can see some lung organoids above from recent exciting research done at Penn.

There is a great deal of legitimate, promising research in the respiratory and lung stem cell arena. This is key context for thinking about trying to fix damaged lungs using stem cells or related technologies.

Stem cells for lungs: clinics and marketing

If we flip things around and instead of asking about “lung stem cells” we ask about “stem cells for lungs”, where are things at today? Note that by this I mean using stem cells or related products to treat lung or other respiratory diseases.

Unfortunately, unproven stem cell or related regenerative material is being sold for lung disease by for-profit clinics. The range of unproven offerings goes from actual stem cells of various kinds to exosomes to platelet rich plasma (PRP). To my knowledge there is no FDA-approved cell therapy for lung disease. See a helpful, cautionary video below from the Pulmonary Fibrosis Foundation.

In terms of direct-to-consumer offerings, stem cell clinic or regenerative clinic firms like Lung Health Institute (more below) often have evolved to meet various regulatory and other challenges. Sometimes this has meant changing their names. Some clinics have changed what they sell over time too, perhaps for economic or FDA compliance-related reasons. So it’s been a little hard to keep track of this space. This post is meant to help clarify things.

the lung health institute
Screenshot from the Lung Health Institute website. Are the results “real” in the sense I think of meaning backed by carefully controlled clinical trials?

Lung Health Institute

What used to be the Lung Institute and is now the Lung Health Institute is one of the most visible clinic firms in this area. They recently got some critical coverage as the WaPo did a deep dive into them. It’s a remarkable, concerning read.

As far as I know they are still also the subject of a proposed patient class-action lawsuit.

Note that lawsuits again stem cell clinics and related firms continue to grow in number more generally. These suits are often settled confidentially out of court. As a result, we don’t necessarily learn that much. Of course, a suit being brought does not mean a firm is guilty of anything and the same is true for this firm.

What does Lung Health Institute sell now?

Based on their website I find it a little confusing as to what they actually do with patients, but let’s dive in and fact check.

In years past they sold “stem cells” for lung disease. You can see documentation of that on archived versions of their website. More recently in the last few years it seems the focus has shifted to a PRP platelet type product. However, now on their site under “Care and Treatment” they prominently list “cellular therapy.” Here’s one of the passages:

“Cellular therapy
(platelet-rich plasma platelet-concentrate (PRP-PC))

When patients receive cellular therapy (PRP-PC), a sample of the patient’s own blood is taken for the cells to be separated and isolated. Concentrated cells are then returned into the bloodstream. This may repair damaged tissue and reduce inflammation, allowing patients to Breathe Easier™, which can improve their quality of life.”

What’s does this mean? Let’s go over it.

Are platelets a type of cell? Are they “cellular therapy”?

Typically in the regenerative medicine field when someone says “cellular therapy” it means living cells are used. They often are talking about stem cells or other cells made from stem cells as well as potentially useful cells of other kinds. This firm’s product seems to me to be a blood concentrate made from platelets.

I was taught and I teach in the medical school here at UC Davis that platelets are not actual cells. They are just cellular fragments. This left me somewhat puzzled by the marketing verbiage from the Lung Health Institute including the statement quoted above.

Would cellular fragments be considered a “cellular therapy”?

It depends on how one defines that term. It is technically correct that other therapies made from cells but not containing living cells like exosomes are sometimes referred to as “cellular therapies.” It gets confusing for the public though.

To be clear, unlike cellular therapies containing living, dividing cells, a concentrate of platelets is not alive in the same sense. It cannot make more cells. I bet the average layperson seeing the phrase “cell therapy” is thinking living cells too.

Does this clinic sell actual stem cells at present? I’m not 100% clear on that, but I don’t think so.

Fact-checking PRP for lung disease

Let’s look more carefully at PRP. Some places are claiming that IV injections of forms of PRP like in the case of Lung Health Institute or stem cells can help respiratory problems, while others promote what generally might be referred to as inhalation (or airway infusion) of stem cells or at least materials purported to contain stem cells.

As to PRP, it is generally injected IV for breathing issues so that raises the issue of how something put into the blood generally could help the lungs.

It seems based on their website that Lung Health Institute is selling more specifically is IV administration of a form of PRP. To me at least as a stem cell biologist this doesn’t make much sense.

Maybe I’m missing something so let’s go through it. They make a form of PRP from a patient’s blood. Let’s call this hypothetical patient “Emily”. So this clinic makes PRP from Emily’s blood and then they inject that platelet concentrate right back into Emily’s blood. Once back in the blood, it is diluted over time in the many liters of her blood. Does that PRP still then even exist in a form distinct from all that blood?

The firm claims they have a special approach called The Pulmonary Trap Method that somehow makes the PRP go to the lungs to then do something helpful. Here’s the specific statement I could find from the clinic website on how this supposedly works:

“The Pulmonary Trap™ method is key to the effectiveness of our treatment™ because of the “pulmonary first pass effect,” in which the body carries all fluid that is administered into your body through an IV directly to the heart and the lungs. So, when our clinicians administer the platelet-rich solution into a patient via an IV, it goes directly to the patient’s heart and lungs, which is exactly the area of the body we are targeting to reduce inflammation.”

So are they claiming or at least implying that the IV-injected PRP does not mix with the blood but gets delivered to the lungs in this way as a distinct solution in the blood? If so, that seems incorrect based on human physiology. Immediately upon injection of a solution into blood it will start mixing with the blood in the arms, etc. Maybe instead they are claiming the PRP is not entirely diluted before getting to the lungs? Maybe the idea is that a little more platelet-derived growth factors get into the lungs than just from the constantly-flowering regular blood before the PRP is fully diluted in all the body’s blood?

Or are they claiming that even when diluted in blood that the PRP does something helpful once it gets to the lungs? I don’t see how a little PRP made from blood diluted into a large volume of the same person’s blood circulating through the body’s blood vessels could do something helpful, even if it gets to the lungs before it is 100% diluted into the blood of the entire body.

It’s a puzzling approach.

Literature on PRP for COPD or other lung disease?

Is this peer-reviewed data published on this kind of approach. I didn’t have much luck finding anything convincing.

Checking PubMed for research articles with PRP and Lung in the titles, only turned up one article, which doesn’t seem relevant.

Another similar search using the full name platelet-rich plasma only turned up 3 articles, and these again are not relevant in my view. I got the same kind of results for searches related to COPD.

There are so many articles on PubMed I could have missed something, but nothing relevant jumped out at me.

I was able to find a “Results” page on the clinic’s website. In my opinion, the information there does not represent rigorous science supporting what they are selling. It seems to largely be patient surveys. I don’t see evidence of strong clinical science such as controlled studies.

Stem cells for COPD and other lung diseases?

What about stem cells?

While the Lung Health Institute may not be selling stem cells any longer for lung disease, some clinics still do. Often they claim fat stem cells will be helpful.

The American Thoracic Society is opposed to the marketing of unproven stem cell offerings for lung disease.

The American Lung Association is too. I personally trust these organizations more than clinic firms selling unproven regenerative offerings for lung disease.

The potential for benefit from the “stem cells” from unproven clinics for lung disease also to me seems low-to-non-existent given that there are common sense hurdles and challenges.

For instance, IV infusions aren’t likely to deliver healthy, persistent populations of stem cells to lungs and even less likely to deliver them to the rest of the respiratory tract. While it is true that there have been reports of stem cells “being filtered out” in the lungs after IV injection (kind of related to that first pass effect mentioned earlier) that doesn’t mean the cells survive or do anything helpful.

I believe that they could do harm too in the lungs like increase inflammation.

Studies on stem cells for lung diseases like COPD

The lungs are literally crawling with macrophages. These are immune cells in the lungs that gobble up things seen as foreign to protect our lungs. It’s quite possible macrophages view anything even appearing as foreign (e.g. why would fat stem cells be present in lungs?) as invaders that should be eaten. This same kind of fate could await cells that are inhaled. I’m not sure it is even known if inhaled cells would make it deep enough in the respiratory tract to get into the lungs. Higher up in the respiratory tract, they would likely get trapped in mucous and/or be coughed back out.

Despite all of this, there are loads of stem cell trials for lung diseases listed on Clinicaltrials.gov right now. Some are sponsored by for-profit clinics, but many others are by research institutions.

One claim is that stem cells injected IV reduce harmful inflammation in the lungs associated with COPD and other similar diseases. I just don’t see good evidence of that. Some years back a placebo-controlled study of prochymal (now Ryoncil) for COPD did not show clear benefit.

Others are skeptical too as seen in this quote from a site called PulmonaryAdvisor:

“At present, there has not been any clinical trial which has demonstrated therapeutic efficacy using stem cells to treat COPD in patients,” said Darcy E. Wagner, PhD, of the Department of Experimental Medical Sciences, Wallenberg Center for Molecular Medicine and Lund Stem Cell Centre at Lund University in Sweden, in an interview with Pulmonology Advisor. “While several different stem cell therapies have been shown to be promising in animal models of COPD, they have not been successfully translated into the clinic. There is still a general lack of understanding of potential mechanisms of action and therefore it is difficult to understand how to best translate findings in the animals into the clinic.”

I have to agree with Dr. Wagner on that.

There may be a future for stem cells for lung diseases of specific kinds, but we are not there yet.

Lung Health Institute Cost $5,000-$7,000

There are also economic costs to going to these clinics.

One can expect to pay around $5,000-$7,000 at a clinic selling biologic products for lung disease.

For instance, the Washington Post mentioned patients paying from $5,500-$7,000 at Lung Health Institute, which fits with my own research from a few years back more generally about clinics.

Of course, it’s not unusual for patients to get far more than one treatment so you have to multiply the cost. Even if any given clinic gives a discount sometimes for repeat treatments, things really add up.

A hypothetical Lung Health Institute patient getting 5 treatments over a period of a few years might pay more than $25,000-$30,000. It’s unlikely that a single treatment of even a rigorously proven regenerative product would give long-lasting relief for lung disease so repeat treatments are probably going to be needed.

Who owns Lung Health Institute?

It’s not a simple question. From the WaPo:

“Meanwhile, Lung Health Institute executives have made plans to expand. Late last year, the Lung Health Institute was acquired by Medovex, a medical technology products company run by former Laser Spine executive William “Bill” Horne. In April, the company raised $7.2 million in new capital, and in recent weeks it raised another $6 million. Horne has said he plans to open more Lung Health Institute clinics…In July, Medovex announced it was changing its name to “H-CYTE” and had entered into a business partnership with a start-up called Rion LLC.”

I’m going to try to do more research on ownership of the firm and may update this post.

Looking ahead

Exploring stem cells or other cellular products as an option for lung disease makes sense if done carefully and ethically. Especially given the sometimes incurable, progressive nature of some lung disease and the suffering of those involved, this is a crucial area. However, beyond basic research, in the clinical sphere rigorous controlled, true clinical trials are the way to go. There should be no charge to patients to be involved. And no hype.

Basic and translational research efforts into lung stem cells and potential cellular therapy for respiratory diseases are important too.

It’s possible that with all the cellular COVID-19 clinic trials ongoing that we may also learn more about the potential of regenerative medicine for diseased lungs more generally.

Going to clinics selling unproven stuff is not the wise way to go in my view. It can potentially make things worse.

References

  1. Stemming Lung Disease?Brigid Hogan, Ph.D., New England Journal of Medicine, June 2018.
  2. Clinic pitches unproven treatments to desperate patients, with tips on raising the cash, William Wan and Laurie McGinley, Washington Post, Oct. 1, 2019
  3. Unsatisfied former patient files class-action lawsuit against Lung Institute, Tony Marrero, Tampa Bay Times, August 25, 2016.
  4. Stem Cell Therapy (Advisory), American Lung Association statement

  1. Note that I’m not a physician so I’m not giving medical advice, but just applying my knowledge as a stem cell biologist who has followed this field for a long time.

6 thoughts on “Fact check: Lung Health Institute & cell therapies for lung disease”

  1. Maybe the author of this nonsense should do some due diligence before posting this editorial, such as reading H-CYTE’s SEC filings and reviewing the licensed Rion patents. I don’t think Todd Wagner, the Viacom billionaire, would be investing in a quack company.

  2. FRANCISCO PRIETO

    This is marketing based on the thinnest of (mostly fictional) threads. It’s unfortunate that this sort of thing isn’t policed better. Some of the terminology they use seems to be dancing around language that might otherwise raise a red flag – e.g. “cellular therapy”, implying but not actually promising stem cells.

  3. Concur! A very dear friend went to the Lung Institute after it opened a clinic in the Scottsdale AZ area. She also had repeating sessions there and at one of their clinics in Texas. She spent a small fortune trying to repair her lungs. The guidance provided by the Lung Institute was to suggest more, more, more. She began treatment when her lungs were at 16%, and against the advice of her pulmonologist, who she said mocked her for trying the stem cell treatment. After two years of multiple treatment, she passed. The Lung Institute and other clinics only sell patients false hope.

    While I am no fan of these faux clinics, neither am I a fan of any government funded/run research clinic. The covid scamdemic has demonstrated that those entities cannot be trusted.

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