India has a problem with stem cell therapies similar to the problem we have here in the U.S. Clinics are allowed to perform certain kinds of stem cell procedures without further government approval, but there is significant debate over whether or not those procedures are appropriate. So government officials have taken a step to address the problem, a step that might be equally useful in this country.
According to news sources, the Indian Council of Medical Research (ICMR) is now asking doctors, clinics, and other stakeholders to submit their own evidence as to the efficacy of the stem cell treatments they utilize. The ICMR hopes to use that information to create an official set of guidelines for stem cell use in India. They might also devise some sort of regulatory framework as well.
Already Standard Therapy
There is one thing in India that makes their environment different from ours. Stem cell treatments for certain immunological and hematolymphoid conditions are not only approved, they are considered the standard of care. Currently there is only one FDA-approved stem cell therapy available in the U.S. It is the bone marrow transplant that has saved the lives of so many leukemia patients.
Be that as it may, regulators in India still hear plenty of complaints among patients who are not convinced their stem cell treatments did anything. Doctors and clinics are likewise asking for clarity regarding how their treatments can and cannot be used. Thus the government is asking for medical community input.
The ICMR specifically wants information about how stem cell treatments are utilized for specific conditions. They want to know how the treatments are performed as well as the efficacy of those treatments. The goal is to separate experimental treatments from those with proven efficacy.
What is interesting is that the ICMR is willing to accept research from doctors and clinics. They are not asking those doctors and clinics to invest tens of millions of dollars in multi-year clinical studies that might still result in being turned down by regulators. Perhaps there is a lesson to be learned here.
No Incentive to Innovate
Here in the U.S., all of those clinics you hear about offering stem cells treatments are doing so under current FDA regulations. Setting aside those clinics that do not follow rules, the rest of the industry treats patients with minimally manipulated autologous material. That is to say that patients donate their own stem cells which are then manipulated only to separate them from the rest of the tissue from which they are being extracted. The cells are reintroduced into the patient’s body through an injection.
As long as autologous stem cell material remains minimally manipulated throughout a given procedure, doctors do not need any further approval from the FDA. Minimally-manipulated autologous material is already deemed safe. And why wouldn’t it be? Patients are being treated with their own stem cells. There is very little risk of rejection or complication.
All of this is said to explain that doctors have very little incentive to innovate. According to the Advanced Regenerative Medicine Institute, they are happy to undergo stem cell training and then return to their practices to begin treating patients.
Perhaps government regulators here can find a way to dispense with the onerous and costly demands of clinical studies and accept data generated by doctors instead. Perhaps anecdotal evidence should play a greater role in determining the efficacy of autologous stem cell procedures. Perhaps if gaining FDA approval were not so expensive and time-consuming, more innovators would be willing to actually do so.