Good news for cell based therapies in the US?
Landmark case: US federal judge rules that using patients’ stem cells to treat a variety of medical conditions does NOT fall under the FDA’s regulatory jurisdiction.
The lawsuit was brought on by the US FDA in 2018 against California Stem Cell Treatment Center (CSCTC) in an effort to assert regulatory authority over stem cell therapies.
This is a huge ruling in favor of patients seeking to utilize their own stem cells as part of a medical treatment.
In a mass email distributed by the Global Stem Cell Group:
" This news opens up the possibilities and sets an important precedent for clinics in the United States to use autologous cellular treatments derived from adipose tissue, giving patients the right to use their own tissue to enhance regenerative processes and fight disease."