Clinical trials are controlled studies that measure the safety and effectiveness of new treatments through consenting participants; in other words, they are designed to test whether drugs or treatments are safe and effective in people. Clinical trials are a lengthy, five-stage research process that begins with cellular studies, progresses to animal tests, then moves to humans if the research appears to have potential. A study must pass through the third phase before the FDA will approve the treatment for legal prescription by doctors to patients. Clinical trials in stem cell research are strictly regulated and monitored by the FDA because the FDA has classified stem cell-based products as drugs. Patients volunteer for clinical trials to potentially try a new treatment and/or to promote research. Clinical trials include both treatment and placebo groups, so there is no way to guarantee that a given participant will receive the trial treatment.
Clinical trials follow strict scientific and quality standards to protect patients and product reliable study results. Trials have eligibility requirements, including inclusion criteria (things required to participate in the study) and exclusion criteria (factors, conditions, etc. that prevent a person from participating). Every clinical trial has unique requirements.
Stem cells cultured at Hope Biosciences are currently at work in dozens of FDA-authorized clinical trials at research organizations and academic institutions, serving patients aged 2–89 years of age. We feel relief every time a client is able to access cells they banked with us and tremendous pride at such a scope of work, unprecedented in the global cell therapy landscape.
We are ALWAYS happy to talk stem cells and offer banking solutions for individuals, families, and businesses, so don’t hesitate to c’mon by for a tour.
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Play through this crossword for a quick and easy explanation of the title on our recently published peer-reviewed article, “Safety and efficacy of autologous, adipose-derived mesenchymal stem cells in patients with rheumatoid arthritis: a phase I/IIa, open-label, non-randomized pilot trial.” Now you can read about our results with a whole new understanding.
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Scroll all the way down for the crossword answer key!
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