FDA Approval

Are Stemedix's therapies FDA approved?

Stemedix is honest about their lack of FDA approval. They mention it in their FAQ page on their website.

Picture taken from http://stemedix.com/faq/ on October 26, 2015.

They also claim their lack of FDA approval is perfectly acceptable, but is this accurate? Are Stemedix's therapies in good standing with FDA procedures? 

What the FDA says about regulation of stem cells in general?

Picture taken from http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm on October 26, 2015.

I feel it necessary to point out that this excerpt came from an article titled "FDA warns about stem cell claims" on the FDA website. So, despite what Stemedix claims, the FDA does feel the need to regulate stem cell treatments. That being said, if a therapy is not yet approved, such as Stemedix's therapies, it must undergo animal studies and clinical trials to assure safety, purity, and potency. Since Stemedix's treatments are not in clinical trial, there is no way to assure that Stemedix's methods assure safety, purity, and potency. They also are not posting any of their own research on animal models or human patients. How are we supposed to know if Stemedix even did research on animal models before trying their own therapy in humans? For all we know, the first patients were the human guinea pigs. Stemedix needs to make such information more accessible to the public if such information exists. 

Picture taken from http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm on October 26, 2015.

In the same article, the FDA warns that even autologous stem cell transplants, in which the stem cells are your own, come with risks. These risks are higher when the stem cells are not used in a homologous manner - or in other words, when the stem cells are used a different way in the therapy than they are in nature. 

Picture taken from http://stemcells.nih.gov/info/basics/pages/basics4.aspx on October 26, 2015

Picture taken from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC138633/ on October 26, 2015. This article describes the differentiation potential of adipose stem cells.

In other words, in nature, adipose stem cells form bone (osteocytes), fat (adipocytes), muscle (myocytes), and cartilage (chondrocytes). 

Picture taken from http://stemedix.com/als/ on October 26, 2015. 

In nature, adipose stem cells do not form neurons, which make up nerve and brain pathways. Yet, in Stemedix's therapies, adipose stem cells do. 

Let's just focus on the logic of this for a second. By just injecting the stem cells into the blood stream, they are supposed to go to the brain to encourage the regeneration of nerves? Even though, in nature, these stem cells cannot form nerves, and the stem cells are not differentiated into nerves prior to transplant? Also, how are the stem cells supposed to leave the bloodstream to encourage the regeneration of nerves? This is why we need FDA regulation and clinical trials to prove that these therapies are effective. Currently, potential patients have no way of knowing if Stemedix's therapies work in the way that they claim to work. We also need to prove that these therapies are safe. After all, these stem cells are not in their native environment when they are in the brain (if the stem cells reach the brain tissue at all), and the are not performing the same function that they do in nature, which makes this therapy potentially risky. 

Also, as a side note, even if the therapy uses a patient's own cells, such as Stemedix's therapies, the FDA still has the authority to classify these autologous therapies as drugs. More information about this can be found at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3353208/. 

What about FDA Code of Federal Regulations 21 Part 1271?

Stemedix claims that their therapies are in compliance with FDA Code of Federal Regulations 21 Part 1271. FDA Code of Federal Regulations 21 Part 1271 refers to the regulation of human cells, tissues, and and cellular and tissue-based products (HCT/Ps). The most recent guidelines can be found at http://www.ecfr.gov/cgi-bin/text-idx?SID=52c7dbca4ecaf8e4c2b58fe0c8fefbd6&mc=true&tpl=/ecfrbrowse/Title21/21cfr1271_main_02.tpl. Due to this being an exceptionally long link, from here on out, references to these guidelines will not include a link. 

Picture taken from the 1271 Regulations. 

There are several things from this single screenshot that we need to discuss in relation to Stemedix's therapies. For now, the only thing you need to take away from this is that the company must register their HCT/Ps with the FDA in order to be in compliance with the regulations for a 361 product unless they meet an exception.

Stemedix claims that they meet an exception by claiming they are in compliance with 1271.15.b. 

Picture taken from the 1271 Regulations.

Basically, Stemedix is claiming that because the stem cells are harvested and transplanted during the same procedure, they do not need to register with the FDA. 

Picture taken from this FDA.gov page on October 26, 2015.

A HCT/P cannot qualify for exception 1271.15.b if the HCT/P is processed between the harvesting and transplantation.

Picture taken from http://stemedix.com/adult-stem-cell-therapy/ on October 26, 2015. 

Stemedix both adds growth factors and activates stem cells with a laser prior to transplanting the stem cells back into the body. Therefore, Stemedix's therapies use additional processing, and they can not claim to be exempt from registering their therapy with the FDA, even though the harvesting and transplantation of the stem cells occurring during the same surgical procedure.

By now, we learned that Stemedix's therapies should be registered with the FDA. As we already learned, one of the ways a product can be registered with the FDA is as a 361 product.

Picture taken from the 1271 Regulations

Returning to this picture, these regulations establish whether or not a product is eligible for regulation as a 361 product. Stemedix's therapies violate two of these requirements. Their therapies are more than minimally manipulated due to all the additional processing of the stem cells between harvesting and transplantation. The stem cells are also not used in a homologous manner because Stemedix uses adipose stem cells to repair nerve and brain pathways. 

Stemedix's therapies do not meet the requirements for regulation as a 361 product. 

Picture taken from 1271 Regulations

Therefore, Stemedix's products should be regulated as a 351 product. Basically, the FDA would refer to Stemedix's therapies as drugs. Their products need FDA approval, along with all other drugs.