Almost all regenerative medicine products for human use will require FDA regulation and clinical trials with FDA oversight.

Based on the new FDA guidance, the US Food and Drug Administration (FDA) clarified their regulatory governance over regenerative medicine products. Almost all regenerative medicine products for human use will require FDA licensure/approval to be marketed to consumers. Before approval, these products require FDA oversight in what is called IND (Investigational New Drug Application) clinical trials. Regenerative medicine products, whether recovered from your own body or another person’s body, include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and/or cord blood stem cells, amniotic fluid, Wharton’s jelly, ortho-biologics, and exosomes.

Early research shows that stem cell therapy is safe and may be effective in the treatment of numerous medical conditions.

Stem cells are unspecialized cells found in the human body that have the ability to self-replicate and develop into a variety of different cell types. In fact, all of the cells and tissues found in the body originated from stem cells. There are multiple different types of stem cells that are involved with the development of the human body including hematopoietic, mesenchymal, neural and epithelial stem cells. For more information on the main types of stem cells please visit our Stem Cell FAQ page here.

In addition to their role in developmental biology, based on the published data to date, stem cells have been found to have numerous therapeutic actions. Naturally, stem cells act as an internal repair system by supporting a multitude of tissue repair mechanisms, as well as replacing damaged and dysfunctional cells. Most of the therapeutic benefits of stem cells are believed to come from their ability to influence the behavior and activity of target tissues via the paracrine effect. The paracrine effect is the cell to cell communication between stem cells and other tissues. This communication involves cellular signals carried by specialized vehicles called exosomes which influence the behavior or activity of nearby and distant tissues in order to restore function. Stem cells also contain numerous growth factors which are thought to be the single most important characteristic of any given stem cell population.

Base on these published data, stem cells have been shown to exert a variety of therapeutic properties including anti-inflammatory, tissue repair, immune modulating and anti-microbial properties. These therapeutic properties often result in reduced inflammation and improvement of cellular function. Considering these properties, stem cell therapy is being actively researched for treating numerous acute, chronic and degenerative diseases. It is also being researched in other innovative and longevity medicine.

To date, there is a significant amount of published human research that demonstrates the safety and efficacy of stem cell therapy in various medical conditions. Although the current data is encouraging in the clinical setting continuously reviewing emerging data is required.