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There’s a dangerous trend out there happening both in the US and in Banana Republic stem cell clinics being pushed by celebrities and physicians that IV stem cell infusions can make you younger. Let’s explore this topic in some depth with some examples of what’s being said and why this isn’t good for the field of orthobiologics. Let’s dive in.

The Sales Pitch

The sales pitch here is simple. If I give you an IV containing young stem cell cells, this will make you younger. The genesis of this concept is based on a tiny bit of science that has been hugely amplified by social media influencers and celebrities, as well as a growing number of doctors that IMHO are playing the get-rich-quick short game.

Where does this sales pitch originate? It came from parabiosis experiments where researchers hooked up the blood supply of an old animal with a young animal. Most of the results (but not all) show that the old, infirmed animal became healthier (4). Was this due to “young blood,” “young cells,” or old blood being cleaned of bad cytokines by the younger animal? Nobody is quite sure.

The Real Science Behind Stem Cells Used for Anti-aging

It’s a bitch getting old. Hence, anti-aging or age management clinics have sprung up worldwide. Most of these clinics focus on simple things like supplementing hormones and bringing things like testosterone (in men and women) or progesterone (in women) back to normal young levels. It’s pretty easy in these cases to see immediate results like a better muscle-to-fat body composition or increased sex drive. However, determining whether someone is aging in reverse is much harder.

So what’s been published to date on stem cell IVs to reverse aging? Allogeneic MSCs have been tested in a small placebo dose escalation trial on the short-term outcomes of patients with mild to moderate fragility due to age (low-functioning elderly people) (1) The good news is that a 100M cell dose seemed to have mild positive effects in a small group of patients with the placebo and 200M dose not producing an effect.

A slightly larger dose escalation trial (phase 2B) is now ongoing, but that study will only include 30 patients per group (2). The good news is that this study will take patients out to 2 years. However, for an anti-aging study, that’s a very short time and a small group size.

This is the list of ongoing human clinical trials to trying to prove this concept (3):

In particular, despite the sales pitches at these clinics, there is zero long-term data from clinical trials showing that giving someone an IV infusion of stem cells reverses aging.

An Ethical Framework

Two weeks ago, I was in contact with a clinic owner offering these anti-aging stem cell infusions. He stated that he had a new venture overseas where he was using induced pluripotent stem cells. Based on how he positioned this and my knowledge of those countries, they will begin using this cell line in patients with very little regulatory oversight. This is very concerning.

As a result, I have created an ethical framework so that physicians and patients can understand when people are placed at too much risk. I have that table below:

For something like bone marrow concentrate, since that’s centrifuging to get the stem cell fraction and then using that in the same patient, it’s in common use now to treat orthopedic indications. For things like adipose stromal vascular fraction or culture-expanded autologous bone marrow mesenchymal stem cells, while these are considered drugs by the FDA, after a period of safety testing that results in publications, they are likely safe to use overseas where regulations would classify these procedures as the practice of medicine.

The amount of data required to prove safety goes up for these next tissues. For example, if you’re selling a Wharton’s Jelly product that aims to preserve live stem cells (which is being sold in the United States without any live stem cells), in the US, you must pursue formal clinical trials to prove safety. Having said that, this type of product would likely be fine to use overseas once general safety was established via clinical publications.

The two levels up are where there are serious safety concerns. For example, culture-expanded umbilical cord MSCs, while being used in many banana republic “stem cell” clinics, present a significant safety concern when being used for something like anti-aging. For example, if these were used to try to cure an incurable and disabling disease, the risk of using them overseas with minimal safety data and without clinical trials likely makes some sense. Having said that, treating otherwise healthy people who want to look or feel younger with these cells disrupts that safety calculus. The risk is too high, and full US-style FDA clinical safety trials are needed.

Finally, we have arrived at the type of cells the clinic owner shared with me that he will soon use on living patients overseas. These are culture-expanded and genetically modified with induced pluripotency. This is a VERY DANGEROUS cell line until proven otherwise with significant safety testing. Using this overseas for an anti-aging indication would be incredibly irresponsible.

My Comments

As an expert in orthobiologics who has used everything from culture-expanded stem cells to PRP on thousands of patients and published dozens of peer-reviewed publications, if a family member came to me and wanted to try stem cells overseas to treat aging, what would I say? My answer in 2023 would be that the risks far outweigh the possible benefits. That assessment may change as more of the clinical trials being performed publish their results.

The upshot? Stem cells to treat aging could be a thing one day, but my guess is that this will be limited in the legitimate medical community to severely frail individuals who can’t care for themselves. It’s unlikely that the thousands of worried aging people lining up to get stem cells infused IV are actually getting any younger, but only time and more published data will tell.

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(1) Tompkins BA, DiFede DL, Khan A, Landin AM, Schulman IH, Pujol MV, et al. Allogeneic mesenchymal stem cells ameliorate aging frailty: a phase II randomized, double-blinded, placebo controlled clinical trial. J Gerontol Ser A Biol Sci Med Sci. (2017) 72:1513–22. 10.1093/gerona/glx137

(2) Yousefi, K., Ramdas, K.N., Ruiz, J.G. et al. The Design and Rationale of a Phase 2b, Randomized, Double-Blinded, and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Lomecel-B in Older Adults with Frailty. J Frailty Aging 11, 214–223 (2022). https://doi.org/10.14283/jfa.2022.2

(3) Garay RP. Recent clinical trials with stem cells to slow or reverse normal aging processes. Front Aging. 2023 Apr 6;4:1148926. doi: 10.3389/fragi.2023.1148926. PMID: 37090485; PMCID: PMC10116573.

(4) Ashapkin, V.V., Kutueva, L.I., Vanyushin, B.F. (2020). The Effects of Parabiosis on Aging and Age-Related Diseases. In: Guest, P. (eds) Reviews on New Drug Targets in Age-Related Disorders. Advances in Experimental Medicine and Biology(), vol 1260. Springer, Cham. https://doi.org/10.1007/978-3-030-42667-5_5

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