The Science

The Science

Stem Cell Treatment & The FDA

Like all cells in the body, brain and spinal cord cells suffer from damage and eventually die over time. At its extreme, the damage and death of brain and spinal cord cells can lead to a myriad of neurological conditions and diseases.

In the area of neurological diseases, there are few conditions where FDA-approved disease-modifying therapies exist.

Among those that do exist, all have limited efficacy to impact the disease trajectory of the conditions they are intended to treat.

Also, the current FDA-approved disease-modifying treatments for neurological disease are associated with varying degrees of toxicity and risk, which may, on an individual level, deter an affected person from accepting one of these treatments.

brain

Stem cell treatments hold the promise of therapeutic benefit for neurological conditions based on the currently published literature.

 

At present, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells derived from umbilical cord blood.

 

These products are approved for use in patients with disorders that affect blood production, but they are not approved for other conditions.