We are on the brink of medical breakthroughs using stem cells. In March 2018, the European Commission approved the first stem cell therapeutic (called Alofisel®, or Darvadstrocel) for treating patients with Crohn’s disease. To say this is a remarkable achievement is an understatement. And the best part? The prescribed therapy is a regimen of adipose derived stem cells (ADSCs). That’s right, the first-ever prescribed stem cell medicine for treating a chronic inflammatory condition is the same source used for FACTORFIVE Skincare products.
Some competitors—unjustifiably—say ADSCs are more inflammatory than bone marrow derived stem cells, and now, it’s time to check the facts.
Although research has identified the therapeutic potency of bone marrow-derived stem cells (BMSCs) years before ADSCs, there are many advantages that make ADSCs the choice stem cells for treating clinical conditions.
If you want more proof that ADSCs are the preferred stem cell type over BMSCs, Figure 2 includes the active, recruiting, and completed clinical trials around the world using stem cells related to clinical uses to treat the skin. Clinicaltrials.gov is the worldwide database that compiles all registered clinical trials involving any investigation agent. Depending on your search filters, anyone can find information about the who, what, when, and where on studies that use or have used any type of stem cell in clinical trials. The downsides are that the information about each trial is brief and rarely are results from these clinical trials reported.
Fit-for-Function
| Terms | Definitions |
| Investigational agent | Any substance including drugs or cells that has been laboratory tested and is seeking FDA approval for clinical use in people |
| Homologous | Same, matching, equivalent, or similar |
| Biologic | Any cell or tissue used for therapy |
| Conditioned media | Cells grow in specific media (it essentially contains their food). Once the cells have been cultured in the media and secreted all their potent actives into it, it’s then called conditioned media. |
Federal regulations in the U.S. impose great scrutiny on stem cells for clinical practice. In order for stem cells to advance to market, safety and efficacy must be achieved (obviously), but there is an important criterion that also needs to be met. FDA says, “homologous use” but it’s more common to say “ fit-for-function.” This phrase is widely used in scientific fields from academia to industry. It validates the reasoning for selecting a specific type of biologic for clinical use, depending on the expected function or effect at the site of injection or transplantation. For instance, ADSCs combined with other cells from fat are used in plastic surgeries as part of fat grafting for breast augmentation procedures, thus BMSCs are not used in these procedures.
This further proves why ADSCs and their proteins are a match for skin maintenance and healing. To demonstrate the preferred use of ADSCs over BMSCs to treat any condition related to skin—because this is fit-for-function—Figure 2 shows the results from my searches. Although FACTORFIVE Skincare products contain only the secreted products (conditioned media) produced by stem cells, the same standards must comply for regulatory compliance and approval for medical use. Since ADSCs naturally maintain fat (hypodermis) which resides directly under the skin, it’s a no-brainer for using ADSCs and their conditioned media for skin maintenance.
With great power comes great responsibility. The caveat is that the use of stem cells has become so attractive that many companies freely use many types of stem cells, even when misused or out of context. In the clinical field, thorough evidence must demonstrate a stem cell is actually a stem cell, but in the cosmetic field, the lack of regulations permits the overuse as a strategy for selling products to consumers that may not fully understand what the skincare products are made of. But that’s where we come in. On behalf of FACTORFIVE, I can assure you that we will always give you the truth about science, stem cells, and skincare.
If you have any further questions, feel free to email me at annie@factorfiveskin.com.
