In my series eight simple reasons to pause before getting an unlicensed treatment from a non-compliant clinic I have covered the first five: (1) potential loss of insurance coverage for negative outcomes that could cost hundreds of thousands of dollars, (2) failure of patient follow up by the doctors and clinics, (3) exclusion from future clinical trial participation, (4) undesired tissue growth, and (5) untrained doctors.
Today, reason #6 is covered: jeopardizing ownership of your own stem cells.
I was having a talk with a patient the other day about stem cells.
This patient, like many stem cell patients, told me:
“I own my own stem cells. They belong to me and I should be able to do anything with them. The FDA should keep their hands off.”
This is a common belief amongst stem cell treatment patients.
Unfortunately, the idea that patients intrinsically & automatically own their stem cells once removed from their bodies is a myth.
There is no law, no court case, and no constitutional right to one’s own stem cells. In fact, legal precedent mostly says the opposite: with only the rarest exceptions, you do not in fact own your stem cells if you had them isolated at a stem cell clinic.
I wish it weren’t true because I personally believe in patient ownership of their cells, but legally patients generally speaking do not have an automatic ownership right to their own stem cells.
Instead, the clinic is more likely to own the cells, not the patient because at most clinics you sign away your rights to the stem cells. Even if there were no document signed specifying the ownership of cells, the legal precedents would support a clinic’s claim that they (and not the patient) own the cells. This is especially true if the clinic amplifies the cells in culture to produce a distinct stem cell product as so many clinics do, but even without amplification the cells may belong to the clinic.
Legal cases such as the Moore ruling and my own private conversations with those in the for-profit stem cell field would suggest that patients have few rights to their stem cells isolated at most clinics and also at research institutions. The important exception is if the forms you as a patient signed with the clinic specifically designate that you retain those rights as a patient.
I wonder how often that is the case.
In John Moore’s case (see image above from CBC), a physician secretly took away his rights to Moore’s own cells and the courts took the doctor’s side including the California Supreme Court in the Moore v Regents of the University of California case.
I also am curious what would happen today if a stem cell clinic found that your cells were extraordinary in some way (say for example that they grew twice as fast as any others of the kind that they had ever seen and they never stopped growing) that could be commercialized OR that they uniquely secreted a very powerful growth factor: who would have the rights to patent the cells?
Read the book, The Immortal Life of Henrietta Lacks, but keep in mind that when it comes to patient ownership of their cells not so much has changed since that time.
In my own upcoming book, Stem Cells: An Insider’s Guide, which will be published in a few months I delve more into this crucial issue and cover additional legal cases that together argue that unfortunately from a legal perspective patients have relatively few rights in most cases to their own cells unless they are proactive and very careful in what they sign.
So for the patients out there making the statement over and over that you have intrinsic ownership rights to your stem cells and that all patients do have that rights, you had better check the facts and very carefully read the release/consent forms that you signed. I hope that you do have those rights, but in most cases patients will not automatically have clear ownership.
For patients considering stem cell treatments, better carefully read the fine print on the documents that the doctor or clinic wants you to sign. Better yet, take them with you and have your lawyer read them before you sign them. See how the doctor and clinic reacts when you ask to take the paperwork with you for your lawyer to examine before you sign it….their reaction may tell you a lot!