They are the cosmetic company with Kathy Ireland as their spokesperson whose anti-aging cream includes extracts from human stem cells.
In Part 1 of this blog series on Stemage I gave some key background and raised some important questions.
I also sent some questions to the company and now more recently to the affiliated company, Scharp Technologies that makes the key ingredient in Stemage, a human stem cell conditioned media product called MDFc19.
In addition, I called Stemage on the phone and talked to a company representative.
Below is a Q&A interview with Dr. David Scharp (pictured above in video screenshot from Stemage Website) about Stemage and MDFc19. Thank you to Dr. Scharp for doing the interview and answering the questions I had.
Out of respect as well as a desire for fairness and accuracy, I held off on posting about my discussion with the phone sales rep at Stemage until I communicated with Dr. Scharp first and also I attempted to dialogue directly with Stemage, which did not get very far. Note that my questions are in blue and Scharp’s answers are below each one in regular text. Also it is worth noting that I do not necessarily agree with Dr. Scharp on various issues.
1. When I called Stemage, a customer rep said that MDFc19 is derived from stem cells isolated from bone marrow. Is that correct? Yes, MDFc19 is conditioned media from the culture of human adult mesenchymal stem cells obtained and selectively purified from the bone marrow of selected donors.
2. When I called Stemage, a customer rep said that the bone marrow comes from mostly deceased donors. Is that correct? If so, why that source? Currently, the donors are paid volunteers that are screened with the bone marrow preparation that is tested at that time and again tested at the time of lot formation. We are in the process of moving to a more readily defined source of human bone marrow donors that is still in progress and thus must remain confidential at this time.
3. How is the consenting of the donors handled, especially if they are deceased? Since they are currently not deceased, standard informed consent that includes appropriate history is obtained with comparison to inclusion and exclusion criteria.
4. Has Scharp Technologies had any discussions with the FDA about MDFc19? Our regulatory activities are based on the opinions of our regulatory consultants who regularly communicate with the FDA. Skin care products are not under the type of FDA regulations that are required for drugs and devices.
5. Do you believe that MDFc19 is a drug? Either way (yes or no), what’s your thinking on that issue? A drug is something that diagnoses, treats, cures, or prevents disease or disorders. MDFc19 is a component of skin care products that are not defined as drugs or devices by the FDA.
6. Since MDFc19 is derived from human donors, is it tested for HIV, HBV, and other pathogens? As above, it is tested twice before release to a skin care formulation.
7. Have there been any clinical studies or trials involving MDFc19? I could not find any in clinicaltrials.gov, but I realize that small studies are not necessarily in that database. There have been several small studies completed with skin care products containing the MDFc19 component that have been examined for safety and evidence of the skin care product’s potential in assisting the natural processes that take place in the skin. These are the normal types of small clinical studies completed for skin care products since they are not defined as drugs or devices that are required to be tested in formal clinical trials. Drugs and device products require a Biological License Application (BLA) to be completed and approved by the FDA with large scale clinical trials before selling the product. These types of large scale clinical trials are what are listed in clinicaltrials.gov, not the smaller clinical trials performed for skin care products. Since skin care products are not listed as drugs or devices, they do not require a BLA before they can be sold.
8. Are there any publications on MDFc19? I was unable to find any in Pubmed. Traditionally, these small types of trials for skin care products are not published. However, Dr. Snyder and I are planning to present and publish the results to the scientific community of the several research projects underway that are designed to define the morphologic, genomic, and proteomic factors that may be involved from the culture of MSC’s in the proprietary media and conditions utilized. Obviously, the results of these studies have to be completed and reviewed prior to making the decision to present and publish the results of each of these studies. The decision to submit patent applications also has to be made prior to submission for publication, especially with the USPTO’s decision to change to “first to file” rather than continue “first to invent.”