During my previous review(see posts):
of important and relevant points the FDA made in the two Guidances that were issued on November 16th about the regulatory framework the FDA presented for dealing with all kinds of HCT/Ps, I tried to provide context for how the FDA felt in particular about using autologous adipose tissue at point-of-care (POC). My conclusion is that except for a very limited approach for fat grafting in mostly cosmetic indications, the FDA has said no to using adipose tissue at POC.
For example, the FDA warned healthcare professionals—yes, healthcare professionals—that enzymatic or mechanical disruption of adipose tissue that resulted in the breakdown of structural elements in adipose tissue made the processing rise above the FDA’s standard for minimal manipulation of adipose tissue. The FDA also indicated that it was not homologus use to use adipose tissue in any form to treat musculoskeletal conditions, including arthritis and tendinitis. So, I think it is fair to say that the FDA is heading in the direction of shutting down the clinics who digest adipose tissue to create a single cell suspension to treat whatever ails the patient, whether it is an autoimmune disease, osteoarthritis, or other painful and degenerative conditions. On the other hand, if you or your clinic want to go through the hassle of submitting an IND, I suspect the FDA will tolerate your non-compliant use of enzymatically-digested adipose tissue to create SVF (stromal vascular fraction) preparations to treat an orthopedic pathology while the IND process proceeds.
But a curious instruction appeared in the Same Surgical Procedure Exception Guidance. The FDA indicated that physicians first should consider if the HCT/P they are making at POC meets the standard of “such HCT/P” specified in 1271.15(b), and if they believed they met the standard, they could avoid registering with the FDA—a very desirable outcome. Of course, the FDA provided an explanation for the kind of processing they would allow and still have the HCT/P be considered “such HCT/P”. For more details please see
Suffice it to say, there isn’t much that can be done to lipoaspirate and still meet the “such HCT/P” standard according to the FDA. But, as an added benefit, if physicians meet the standard in 1271.15(b), the FDA allows them to ignore the four elements listed in 1271.10(a). Non-physician manufacturers still need to sort out if the HCT/P they want to commercialize meets the elements of 1271.10(a), so that they can sell the HCT/P without performing pre-market approval studies.
While I believe the “such HCT/P” regulatory hoop is very tight, and doesn’t give physicians much leeway in trying to exploit it, there is one scenario that I think raises some interesting issues. There is a device on the market that is 510(k)-cleared (Lipogems System, K171135) that allows physicians to use mechanical disruption to create a preparation of mechanically fractured adipose “tissue”, which the FDA determined to be substantially equivalent to devices for producing fat grafts from lipoaspirate. The following is the indications for use taken from the most recent 510(k) letter issued to Lipogems with edits.
The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.
This device has gained in popularity for treating all kinds of orthopedic pathologies with physicians who think they are being compliant when working with autologous adipose tissue at POC, because they think this cleared device is the epitome of minimal manipulation. Actually, making fuzz balls, which is what I call the product produced after processing adipose tissue with the kit, is accepted by the FDA for indications for use that are limited to “…the transfer of harvested adipose tissue…” during surgical procedures requiring subcutaneous tissue support or cushioning. Most importantly, nothing in the language of the indications for use would allow a physician to treat musculoskeletal pathologies, like osteoarthritis, which is consistent with the fact that the FDA considers such treatments to be a non-homologous use.
So, a burning question in the regenerative medical blog-o-sphere concerns how the FDA views using the Lipogems System for treating degenerative conditions like osteoarthritis. The reason there is uncertainty, despite the direct statement by the FDA that using adipose tissue-derived preparations to treat musculoskeletal conditions is a non-homologous use, is that the FDA has directed physicians to ignore minimal manipulation and homologous use if the physician believes they satisfy the conditions in 1271.15(b).
I will consider in the next post the implications of the two Guidances on the possibility of physicians relying on the Lipogems System to produce fuzz balls to treat whatever pathologies they want.