StemCell Therapy

Ive blogged before on the stem cell wild west, or the concept that theres more misinformation on stem cells these days for patients and physicians than good information. Many colleagues act surprised when I tell them the FDA considers the stem cells that they are isolating from fat in their office an illegal unapproved drug. I then have to explain loads of information to them, so I thought that instead Id write a blog post about the topic and give everyone a link.

First, so far, looking at all of the data published by FDA and the existing and planned regulations, same day stem cell procedures using bone marrow dont seem to be impacted by any FDA rule changes. Second,for a much more detailed (and boring) technical discussion on the topic, see my recent paper published in the AAPMR journal. Ive also published another similar paper in the same journal (link here). Third, I have long disagreed with the FDAs position to regulate fat stem cells as a drug, as both papers describe. Having said that, the FDA gets to create the rules on this issue, so dont kill the messenger.

So whats the evidence that the FDA considers fat stem cells created at the bedside an unapproved drug? To understand this, you first have to understand that the agency created a line in the sand approach called manipulation. If what you do to cells crosses this line, then the cells (even those from the same patient and even if what you do occurs in the same surgical procedure in the doctors office) are considered a drug. TheFDA began making its position clear on this issue in 2011. The agency was asked by physicians wishing to process fat at the bedside to obtain stem cells to treat knee arthritis whether the process would make the cells a drug or would covered under the practice of medicine (i.e. not a drug). As you can see from reading the FDA response linked above, the FDA considered the cells a drug. A very similar response was obtained when a Maryland plastic surgeon asked if fat processed in his office to obtain stem cells for a cosmetic procedure would be a drug.

If the two above letters left any doubt in anyones mind that the FDA considered fat stem cells a drug, more recently, the FDA has issued several draft guidances to spell out its position. The most recent document seems to be aimedsquarely at doctors who believe that processing the patients own fat stem cells in their office isntthe manufacture of an illegal drug, but rather just the routine practice of medicine.

So heres a quote from that document:

Processing to isolate non-adipocyte or non-structural components from adipose tissue (with or without subsequent cell culture or expansion) is generally considered more than minimal manipulation. This is because the connective tissue and structural components of the adipose tissue are entirely removed from the non-adipocyte or non-structural isolates, thereby altering the original relevant characteristics relating to the tissues utility for reconstruction, repair, or replacement.

Still not clear? Try this paragraph:

Example A-1: Adipose tissue is recovered by tumescent liposuction. The adipose tissue undergoes processing or manipulation (e.g., enzymatic digestion, mechanical disruption, etc.) to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells for clinical therapeutic uses. This processing breaks down and eliminates the structural components that function to provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement. Therefore, based on the definition of minimal manipulation for structural tissue, this processing would generally be considered more than minimal manipulation.

I can just hear the peanut gallery now, shouting, but wait, Im still covered as a doctor under the same surgical procedure exemption (21 CFR 1271.15(b))! What does this mean? The FDA carves out an exemption from the drug regulations for doctors who minimally process tissue during the same surgical procedure.

Read this article:
Are Fat Stem Cells a Drug? - Regenexx

This entry was posted on June 1, 2015 at 4:44 pm and is filed under Fat Stem Cells. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |