This is especially true for human umbilical cord UC storage. As Fong et al. This practice leads to mixed heterogeneous populations of MSCs since some cells are derived from the UC compartments, which are not as useful for clinical studies.
What does this big development mean in practical terms and how might it play out? Overall, Zettler had this take: What if anything is the immediate effect of these 2 suits by DOJ?
In theory can the firms just continue business as usual for the time being? A permanent injunction does not go into effect immediately after the government files its complaint. What about a temporary injunction? I think we would already know if the government were seeking a temporary injunction—I think that would have been included in these complaints.
But the government can ask the firms to agree to cease producing and marketing their products while the litigation is ongoing. In the USA vs. Regenerative Sciences case, for example, the firm agreed to cease producing its product while the litigation was ongoing basically when the government filed its complaint.
If the same thing happened in one or both of these new cases, that might explain why the government did not Stem cell plight a temporary injunction.
Or, given that each set of defendants either had been warned Stem cell plight FDA or been the subject of regulatory action previously and had not stopped their activities before FDA filed the complaint seeking the injunctions, it may be that they are not willing to enter into such an agreement.
How long might these court cases take? For example, in the Regenerative Sciences case, FDA filed its complaint asking for a permanent injunction in Augustand the trial judge granted that request in July Regenerative Sciences then appealed, and the D.
Having spoken to some of the defendants, you probably have a better sense than I do as to whether they intend to litigate this—but I would guess perhaps yes, given some of their statements arguing that they are not subject to FDA regulation and the fact that the activities that FDA has asserted are illegal appear necessary for their current business models.
Regenerative Sciences case, in which FDA prevailed on the question of proliferated stem cells as drug products requiring premarket approval, relevant here in other ways?
At least in the new USA vs. California Stem Cell Treatment Center, et al. Other relevant case law? Yes, I think the Regenerative Sciences case is relevant.
The legal theory on which FDA is proceeding is very, very similar e. One wrinkle is that the Regenerative Sciences case was decided in the D. This means that the Regenerative Sciences opinion may be persuasive to federal judges in the Southern District of Florida and Eastern District of California, where these cases have been brought, but it is not controlling precedent.
That is, federal courts in different circuits could come out differently. Regenerative Sciences is the most relevant and analogous case that I can think of. Is there any legal basis or precedent for that being relevant here?
The notion that patients have a so-called right to their own cells is not legally relevant in my view. Moreover, as FDA explained, these cells are more than minimally manipulated and not for homologous use, among other things.
Something that is arguably more legally relevant is the idea that the defendants are engaged in the practice of medicine, not the manufacture and marketing of drugs and biologics. But assuming the courts follow Regenerative Sciences, that argument should not be persuasive. To your knowledge are these cases involving DOJ in the stem cell sphere unprecedented?
The legal rationale for these cases is very similar to that in Regenerative Sciences. I think FDA has strong legal arguments in favor of its request for an injunction.
Additionally, FDA has a strong public health argument as well. For the California Stem Cell Treatment Center et al action, there is also the use of the Vaccinia Vaccine, which frankly sounds quite scary. The strong public health arguments may make a judge more inclined to agree with FDA here.
I think this is a positive development. It shows that FDA is becoming more serious about its regulation of stem cell clinics, and is willing to do more than send warning letters when patients are at risk of serious harm.For the California Stem Cell Treatment Center et al action, there is also the use of the Vaccinia Vaccine, which frankly sounds quite scary.
The strong public health arguments may make a judge more inclined to agree with FDA here. For example, a stem cell cannot work with its neighbors to pump blood through the body (like a heart muscle cell), and it cannot carry oxygen molecules through the bloodstream (like a red blood cell).
However, unspecialized stem cells can give rise to specialized cells, including heart muscle cells, blood cells, or nerve cells. Stem Cell Plight. Therefore, in order to protect the fate of humans we must limit our research in this field, for we know nothing of its true nature - Stem Cell Plight introduction.
Every organ in the human body is composed of tissue, and every tissue is composed of compacted cells. From Regenokine treatments to edible phytoplankton drops to NFL players traveling to Europe for stem cell injections that would be illegal in the USA, Thanks for the interview.
Shawn hearing your plight and story givs tons a hope. I know you guys hear that all the time, but still I have to reitterate. At first, he wanted to forget that it ever happened by returning to his life of touring, a risky operation given that his stem cell transplant made him very susceptible to infection.
McMahon’s struggles aren’t rare among young adult cancer survivors. Find out how one man resorted to stem-cell therapy to repair his own heart in this exclusive Men's Health article. After an article about his plight appeared in a local newspaper, O'Leary.