iDrip Stem Cells: This Is So Illegal…

 The stem cells we offer are Cultivated Umbilical Cord Mesenchymal Stem Cells. As an extension of fetal cells, UCMSC’s offer high plasticity and decreased risk of rejection or GVHD.

We are working with a “Class 100” lab located in California that specializes in advanced therapies, such as regenerative medicine. The lab has a registered IND account and FDA approval to store, work with, and distribute these cells and exosomes. Our cultivated stem cells and exosomes offer higher efficacy and better quality compared to our competitors who use uncultivated cells.”

Why This Is CRAZY

First, let’s dissect what Mimi sent my colleague:

• iDrip offers “cultivated” umbilical cord stem cells. From this email and looking at their website, they appear to be offering culture-expanded mesenchymal stem cells derived from umbilical cord blood.
• To do this legally, the company selling the cells or iDrip would have to have an FDA-approved BLA (Biologics License Application) which takes about 5-7 years of clinical trials per medical indication to get. Meaning that in order to treat arthritis, that would be one drug approval and in order to treat something else yet another drug approval.
• An “IND” is an FDA approval only to study a drug product (the cultivated cells) in a specific clinical study with strict inclusion and exclusion criteria. Meaning that there is no way that the FDA would allow iDrip or any other company to use these cells outside of a study to be given to random people in physician’s offices or at their homes. Hence the term “registered IND account” makes no sense. Meaning that contrary to what iDrip wrote in this email, the company has no FDA approval to “store, work with, and distribute these cells and exosomes”. How do I know that? At the time of this writing, there is no FDA approved culture-expanded umbilical cord derived drug product.
• They also claim that these cells have a decreased risk for GVHD. That’s Graft vs. Host Disease. All umbilical cord transplants are matched between the donor and recipient, which is what reduces the chance of rejection (GVHD) (1-5). If these cells are isolated and culture-expanded, there could be a lower chance of rejection, but since this cell type has not been cleared yet with any FDA approval, nobody has any idea of how the body would respond to this product. To learn more about GVHD, see my video below:

Not Knowing Which End Is Up

IMHO, it’s one thing to sell culture-expanded stem cells without an FDA drug approval, but quite another to have no idea which end is up based on what you write on your website. Let’s take a look at this statement and use it to learn something about cultured stem cells:

This is the statement that makes no sense: “The blood is then sent for cell sorting of the RNA and DNA extractor making the stem cell transplant a universal donor.” What they are trying to reference here is FACS or Fluorescence-Activated Cell Sorting. This works by an antibody binding a specific protein on a cell’s surface and then the machine deciding which cells have been marked in that way in order to sort the cells. To learn more about this concept of cell surface markers on stem cells, see my video below:

The statement that sorting cells has something to do with RNA and DNA and adding the term “extractor” makes no scientific sense. This statement was clearly written by somebody without any basic knowledge of stem cells and how they are isolated for culture.

The upshot? Would I allow a family member to get culture-expanded umbilical cord stem cells placed in my veins? Heck no. This is not an FDA-approved product as the agency has approved no culture-expanded cell line for clinical use to be delivered IV for any of the indications listed on the iDrip website. I think the uneducated writer of this website has confused a number of concepts. For example a 361 tissue registration and an FDA 351 drug approval. One is a simple 45-minute online registration and the other is a 5-7 year approval process per disease that costs hundreds of millions of dollars. So for iDrip, IMHO what they’re selling is clearly being misrepresented.

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References:

(1) Eapen, Mary et al. Mismatched Related and Unrelated Donors for Allogeneic Hematopoietic Cell Transplantation for Adults with Hematologic Malignancies. Biology of Blood and Marrow Transplantation, Volume 20, Issue 10, 1485 – 1492. https://www.ncbi.nlm.nih.gov/pubmed/24862638

(2) Flomenberg N, Baxter-Lowe LA, Confer D, et al. Impact of HLA class I and class II high-resolution matching on outcomes of unrelated donor bone marrow transplantation: HLA-C mismatching is associated with a strong adverse effect on transplantation outcome. Blood. 2004;104(7):1923–1930. https://www.ncbi.nlm.nih.gov/pubmed/15191952

(3) Holtan SG, Pasquini M, Weisdorf DJ. Acute graft-versus-host disease: a bench-to-bedside update. Blood Jul 2014, 124 (3) 363-373; DOI: 10.1182/blood-2014-01-514786

(4) Lee SJ. Classification systems for chronic graft-versus-host disease. Blood Jan 2017, 129 (1) 30-37; DOI: 10.1182/blood-2016-07-686642

(5) Socié G, Ritz J. Current issues in chronic graft-versus-host disease. Blood Jul 2014, 124 (3) 374-384; DOI: 10.1182/blood-2014-01-514752