MD Magazine published a brief interview with a well-known cardiologist and director of the Interdisciplinary Stem Cell Institute at the University of Miami in mid-September 2019, addressing the question of why stem cell research in the cardiology field appears to be lacking. In a nutshell, Dr. Joshua Hare says the big issue is money – or rather the lack thereof.

Dr. Hare’s assessment relates only to stem cell research in cardiology. But let’s step outside that confined arena and look at it on a broader scale. There are plenty of research projects now ongoing at universities and research hospitals. Yet in the private sector, very little progress is being made. There are very few privately funded projects looking into things as basic as stem cell treatments for musculoskeletal injuries.

Could it be that the lack of money is the culprit behind it all? It’s reasonable, especially when you consider the amount of money private sector enterprises invest in new drugs and medical devices. To say it is a lot would be an understatement.

Many Years and Millions of Dollars

Bringing new drugs and medical devices to market is no easy task. It takes many, many years of research and millions of dollars in investments. Some projects have been known to cost billions.

Money is not necessarily a problem for universities and research hospitals more than happy to accept grant money from a variety of sources. But such projects rarely yield marketable results. Nearly all of the new drugs, medical devices, and procedures that make it to market are produced by the private sector. Therein lies the rub.

It’s not worth it for private sector companies to invest millions of dollars in a new pathway if they are not reasonably assured of success. So they tend to focus on projects they feel are financially safe. This is understandable. The medical field is just too risky to put up millions only to find out that you don’t have a viable pathway at the end of it all.

Government is Trying to Help

The government is trying to help change the game for stem cell research. Long before the FDA first announced plans to clamp down on stem cell clinics operating beyond current regulations, Congress was busy passing the 21st-Century Cures Act, a piece of legislation that allows the FDA to fast-track stem cell therapies that meet minimum safety requirements.

The 21st-Century Cures Act is a very good piece of legislation that was much needed at the time. But government can do better. They can apply the same principles universally across the healthcare board so that the private sector can get new drugs, procedures, and medical devices to market faster and less expensively.

If they did that, regulators would be freeing up a ton of time and financial resources that the private sector could put back into stem cell research. In the absence of such sweeping reform, the private sector has to wait until their public research counterparts give them valid reasons to invest in the new pathways.

In the meantime, organizations like the Advanced Regenerative Medicine Institute will continue to train doctors to utilize stem cell therapies – in accordance with current FDA regulations – to treat musculoskeletal injuries and disease. That training is also much needed. Furthermore, the doctors who receive it go on to help their patients live better lives.

It’s all good, but the potential for so much more is there. What is not there is the money to develop it. And that’s a shame because stem cell therapy could revolutionize modern medicine.

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Sara T. Loving

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