Regenerative Medicine & Stem Cell Therapy

Placental/Umbilical Tissues/Biological Allografts (FDA: HCT/P – Stem Cells)

FDA Disclaimer

1) Throughout the US and spanning the globe, the science of Regenerative Medicine is gaining acceptance and support as an important part of the future of advanced medicine. Especially as it relates to the use of Placental/Umbilical Tissues/Biological Allografts (FDA: HCT/P – Stem Cells), there is growing evidence that conditions and illnesses that were previously untreatable, might actually be curable. Thus, every major university in the US and around the world is studying this new science.


2) The good people who work for State and Federal agencies who regulate clinical medicine, are trying the keep pace with the rapid advancement of the field. Thus, Federal and State laws and regulations regarding the clinical use of Placental/Umbilical Tissues/Biological Allografts (FDA: HCT/P – Stem Cells) in the USA is mercurial, and constantly evolving. Treatments that are allowed today, might be illegal next week.


3) These laws and regulations pertain to all Placental/Umbilical Tissues/Biological Allografts (FDA: HCT/P – Stem Cells), whether harvested from a patient’s own body, or from placental tissues, such as umbilical cords and amnion.


4) As the regulations are numerous and newly constructed, they are often complicated and unclear, and a challenge for clinics and physicians to follow.

For instance, even though there is growing and substantial evidence that certain treatments are safe and highly effective, NO CLAIMS can be made by any clinic that performs them. Clinics are even forbidden to share on their websites, patient testimonials who are reporting their experiences.  Thus, though such information might be vital for those seeking treatments, and though many thousands of such testimonial videos have been created, clinics cannot provide such testimonials on their websites or literature.

Until such time as the FDA has determined that a treatment is safe and effective, clinics are not allowed to share the results they are seeing from the treatments.  Clinics are only allowed to share educational materials with the public by citing published research, but they are not allowed to state that stem cells are effective treatments for anything.

Unfortunately therefore, as many countries have taken the lead in Placental/Umbilical Tissues/Biological Allografts (FDA: HCT/P – Stem Cells) research and clinical treatments you might have to leave the U.S. to find the preferred treatment you are seeking.


5) Special provisions have been created to support the advancement of clinical medicine, focused on clinical studies and research. These include clinical studies under the auspices of an Institutional Review Board – IRB and IND – Investigational New Drug.


6) Additionally, “Compassionate Use” or “Expanded Access” provisions have been created for patients who are suffering from an immediately life-threatening condition or serious disease or condition to gain access to an investigational / experimental medical treatment (such as Placental/Umbilical Tissues/Biological Allografts (FDA: HCT/P – Stem Cells)) for treatments outside of clinical trials when no comparable or satisfactory conventional therapy options are available, applicable or advisable. 

  • Examples include conditions such as:
  • Alzheimer’s, ALS, MS, Parkinson’s etc.
  • Duchene Muscular Dystrophy, Cerebral Palsy
  • Autism, IPF
  • Autoimmune diseases such Lupus, Rheumatoid Arthritis, etc.
  • Degenerated Joints requiring surgery

For questions, feel free to call us at: 949-428-4500 or use our online consultation form.