Sacramento amniotic stem cell clinic advertises again, but by another name

Remember Nervana Stem Cell Center? This is an amniotic stem cell clinic here in the Sacramento area, which I’ve posted about before here and here.

One big question about Nervana remains unanswered: is its apparent marketing of amniotic stem cells for arthritis and other conditions is OK with the FDA?

Another question has been, “who are the medical providers at the clinic?” There are indications that these physicians are Drs. Tushar Goradia and Clarence Lee.

Lee Medical Group Stem Cells

I first noticed Nervana because of full-page ads in the local paper here, The SacBee. A couple of days I noticed new giant ads in the paper for stem cells, but puzzlingly there was no mention of Nervana at all anymore. Instead it said “Lee Medical Group” What the heck? Another new stem cell clinic in the area or not?

I’ve pasted a photo of the ad here.

I called the phone # on this new ad and the representative answered the phone, “Nervana Stem Cell Center”. I guess it is the same company so why the change in the name in the ad? I didn’t get an answer from the Nervana person on the phone.

There are a lot of remaining questions about all of this.

5 thoughts on “Sacramento amniotic stem cell clinic advertises again, but by another name

  1. Again, any amniotic tissue-derived product currently registered as an FDA 361 HCT/P should not contain any viable cells. Why? Because the rules for registering a 361 HCT/P (21 CFR Section 1271.10) prevent the inclusion of metabolically active (aka living) cells.

    Moreover, the FDA’s Tissue Reference Group has stated that an amniotic product which contains living cells is not a 361 product, but a 351 drug. This was further reinforced in 2013 with an FDA untitled letter to Osiris Therapeutics stating that their Ovation and Graffix products were not 361 HCT/Ps, but were drugs given their inclusion of living cells.

    For some time, I have been attempting to understand the inner workings of “amniotic stem cell therapies” that are offered at numerous medical facilities nationwide. To the best of my knowledge, none of these 361 products contain living cells, nor should they based upon their current product registrations. I have personally examined several of these products in the lab and have had zero success in obtaining a culture expandable population of cells of any type, from any product.

    In my opinion, any physician administering these 361 products as stem cell therapies is either: A) injecting an illegally manufactured drug, if the said product actually contains viable stem cells, or more likely B) knowingly or unknowingly misleading consumers by selling expensive stem cell injections that do not actually contain viable cells of any type.

    If anyone has evidence to suggest otherwise, I would be very interested in learning more.

    • @Dustin,
      So far I’m not clear on whether this clinic claims to use living stem cells or some extracts of amniotic stem cells.
      The other issue is homologous use as I don’t see similarity between amniotic membrane and, for instance, adult joints.

  2. @Paul – regarding homologous use, I read comments on here about bone marrow stem cells (BMSC) being a no-brainer for joint repair, but aren’t these hematopoietic stem cells, i.e. not osteogenic or chondrogenic?

    I couldn’t find any reports on definitive bone and cartilage stem cells, so that would make all stem cell therapies for joints non-homologous use, be it BMSC, fat stem cells or amniotic.What am I missing?

    • @Gary,
      You raise an interesting point. I guess the argument goes (and I’m not making it, but summarizing it) that bone marrow cells are at least related to bones and cartilage and in fact some cells in marrow do in fact have osteogenic and chondrogenic potential. If one purifies hematopoietic stem cells then you’ve taken a step away from this function and have a product more focused on blood forming functions, but few if any clinics go to that extent of purification. From a regulatory perspective I have not seen the FDA raise concern about the use of marrow cells for joint issues.
      Adipose and amniotic stem cells are dramatically further removed biologically and functionally from bone and cartilage.

  3. @Paul – thanks, that was the missing piece of info – purification (or lack thereof).
    So the argument is that it’s OK to put bone-marrow aspirate in the joint as it contains osteogenic and chondrogenic stem cells – even though aspirate contains hematopoietic stem cells too, which are not found in joints and are hence, non-homologous. Hmm…

    Given that MSCs are a mixed population of stem cells, there will always be some non-homologous cells injected. So we need a more structured and scientific definition of non-homologous use, e.g. one based on stem cell lineage and differentiation potency, as well as dose of residual non-homologous cells.

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