Understanding the Primary Pathways to Stem Cell Therapy

Regenerative medicine is a field of science focused on repairing, replacing, or regenerating damaged human cells, tissues, or organs to restore normal function.* It harnesses the body's own healing capabilities, often using stem cells, to treat diseases and injuries that were once considered permanent.

The field of regenerative medicine is constantly evolving, bringing new hope to families everywhere. Preserving your baby’s newborn stem cells is a decision that opens the door to a range of potential health treatments.

At Cryo-Cell, we are committed to helping you navigate these opportunities.  

Currently, there are three primary pathways for using stored cord blood and tissue stem cells:  

  • Approved Treatments 
  • Participation in Clinical Trials 
  • Expanded Access under State-Level Legislation

Let’s explore what each of these mean.

Approved Treatments

Cord blood is a proven source of hematopoietic stem cells, which are currently used to treat nearly 80 diseases and conditions. These include various forms of leukemia, lymphoma, anemias, and inherited metabolic disorders. For decades, these stem cells have been used in transplants to rebuild the blood and immune systems of patients, offering a standard of care and treatment.

The Future of Treatment: Clinical Trials

For conditions not yet on the approved list, clinical trials are paving the way for future breakthroughs. These studies are essential for developing the next generation of therapies and are strictly regulated by the FDA to ensure patient safety. Researchers are actively studying the potential of stem cells to treat conditions like cerebral palsy, autism and type 1 diabetes.

Expanded Access to Therapies: State-Level

As the science of regenerative medicine evolves, so does the regulatory landscape surrounding it. A growing legislative trend across the country is establishing frameworks for stem cell therapies. Several states, including Nevada, Utah and Texas with its "Right-To-Try" law, have passed legislation that permits non-FDA-approved stem cell therapies under specific conditions.

Florida has recently joined this list with the passage of its new Stem Cell Therapy Bill (SB1768). As of July 1, 2025, this groundbreaking legislation empowers Florida physicians to administer promising stem cell therapies not yet approved by the FDA. This legislation is a significant advancement for patient rights, establishing a clear quality standard and access to therapies. It ensures that therapies utilize high-quality, ethically sourced allogeneic stem cells from accredited facilities. This new law opens the door for high-quality treatment options in key areas, including:

  • Orthopedic (e.g., joint repair, tissue regeneration)
  • Wound care (e.g., chronic wound healing)
  • Pain Management (e.g., reducing inflammation)


As part of our commitment to advancing regenerative medicine for families, Cryo-Cell is proud to have been a key advocate for this legislation, which was signed into law by Governor DeSantis.   Validating our impact, the lead lobbyist for the bill wrote to us directly, stating: “Thank you so much for all of your help. It really made a difference – truly it made a difference.”

This new law reflects a growing recognition of regenerative medicine's potential, and offers new hope and possibilities for patients. As this field of medicine continues to advance, laws like this are essential for bridging the gap between scientific discovery and patient care.
 
The Future Is Bright For Families



“We are proud to have been a key advocate for Florida. It represents our unwavering commitment to expanding the frontiers of regenerative medicine.” 

-David Portnoy, Chairman of the Board and Co-CEO


*Regenerative Medicine. AABB. Retrieved from: https://www.aabb.org/-news-resources/resources/cellular-therapies/facts-about-cellular-therapies/egenerative-medicine.