In a recent stem cell lawsuit in California brought by the Food and Drug Administration (FDA), a federal judge, Judge Jesus Bernal of the central district of California, entered a judgment in favour of the defendants, California Stem Cell Treatment Center (CSCTC) et al.
The court decided that the defendants' medical procedure that uses patients' stem cells to treat different diseases and medical conditions does not fall within the FDA's authority. What is concerning is that this could lead to an increase of clinics providing stem cell treatments that are scientifically unproven and potentially risky, an ongoing issue in US (and elsewhere).
This case was brought against the CSCTC, Cell Surgical Network Corporation and individual defendants, Dr Elliot Lander and the late Dr Mark Berman. The procedure they adopt involves the removal of patients' fat tissue to isolate stem cells.
CSCTC has been challenged by a court injunction filed by the Department of Justice at the request of the FDA. The lawsuit alleged that the defendants manufactured stromal vascular fraction (SVF) products from patient adipose (fat) tissue without first receiving FDA's formal approval for a new drug. SVF cells are comprised of multiple cell types found within adipose tissue; these include mesenchymal stem cells, haematopoietic cells, and early progenitor cells among other cells. SVF cells are the naturally occurring part of the adipose tissue that does not contain the fat cells.
The company argued that a patient's stem cells are not considered drugs regulated by the federal agency. The FDA alleged that using the patient's stem cells as part of a stem cell medical treatment was comparable to manufacturing a drug; thus, this practice is subject to FDA jurisdiction.
The court disagreed with the FDA, and stated that the surgical procedure does not create a new drug. 'The SVF cells are not altered, chemically or biologically, at any point during the SVF surgical procedure. There are no genes added to or removed from the SVF cells during the SVF surgical procedure. The SVF surgical procedure does not change the size or genetic makeup of the SVF cells. The procedure does not alter the biological characteristics of the SVF cells, nor does it affect their ability to proliferate. The SVF surgical procedure does not create any new material or introduce any foreign article into the body. Unlike manufactured drugs, the SVF surgical procedure does not carry any cellular or tissue-based product that did not previously exist within the patient.'
The court ruled that neither the defendants' SVF surgical procedure nor its expanded mesenchymal stem cells procedure are regarded as drugs within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA). Therefore, these procedures are not subject to the FDCA's adulteration and misbranding provisions. The defendants' SVF procedure but not the expanded MSC procedure also qualifies for the same surgical procedure exception.
Previously, Judge Bernal had ruled against the FDA and the Department of Justice requests for a summary judgment; this is a decision entered by the court for one party and against another party without a court trial.
Judge Bernal's decision has now caused regulatory uncertainty. It is noted that the judge's decision is inconsistent with a previous judgment on an identical case in Florida. In that case, the court granted a summary judgment against the defendants, US Stem Cell Clinic. The defendant appealed the decision, yet the court still ruled in favour of the FDA, with the defendant losing the appeal.
There are serious concerns raised over Judge Bernal's decision. Clinics must provide evidence-based stem cell therapies and the FDA, as a government regulatory agency, plays a crucial role in ensuring this. A prominent stem cell association, the International Society for Cell & Gene Therapy (ISCT), issued a response to the court ruling, stating that the judge's decision has widespread consequences for the cell and gene therapy field.
Dr Laertis Ikonomou, chair of the ISCT Committee on the Ethics of Cell and Gene Therapy said, 'ISCT has worked for many years now, alongside the FDA and other regulators across the globe, to ensure all those offering cell and gene, and advanced therapies, operate within established clinical regulatory frameworks to uphold scientific standards and ensure treatments are safe and effective before they reach patients. Cell and gene therapies currently hold unparalleled potential to treat a vast range of conditions that are underserved needs. However, as one of the most advanced and novel fields of medicine, enhancing patient's own cells, these therapies must operate entirely through a global regulatory framework subject to the most stringent scientific standards.
Bernal's judgment is a victory for the private clinics providing these kinds of therapies. But for others, the ruling is considered a flaw. It could create opportunities for unscrupulous for-profit private clinics to provide purported stem cell treatments that are scientifically unproven and potentially dangerous for vulnerable patients.
Stem cell research is a holy grail for treating various diseases and conditions. However, much more work is needed to translate this research into safe and effective therapies. Currently, the range of illnesses for which there are proven treatments based on stem cells is minuscule. The only established safe and effective stem cell treatment is haematopoietic stem cell transplantation (HPC). The other stem cell therapies are unproven and experimental.
Potential medicines are developed in the lab and then translated into products for medical use. They require full independent review by regulatory agencies like the FDA to ensure they are safe and effective. Despite scant evidence for their safety or efficacy, some for-profit private clinics, which are skipping this critical path, promote stem-cell-based treatments on various sources, including the internet. There are patients who suffer adverse effects after receiving these so-called treatments, such as blindness and tumour formation.
In light of this ruling, some unscrupulous clinics may be encouraged to continue providing unproven stem cell treatments to desperate patients. Clinics such as the now closed StemGenex in California, had to pay out over three million US dollars as a class action settlement to its former patients for ineffective 'stem cell treatments' they claimed could treat many illnesses (see BioNews 1138). Without the regulation of stem cell and gene therapies, by a governing body such as the FDA, there is significant concern for patient safety.
It is unknown whether the FDA will lodge an appeal.
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