We’re seeing more muddy waters in the stem cell universe. A chiropractic stem cell and alternative medicine clinic has popped up calling itself, of all things, CIRM. On another front, an already controversial docuseries set to air tomorrow combines interviews with prominent academic stem cell scientists and unproven stem cell clinic folks, muddying the waters. Was that the goal?
What’s the deal?
As to the stem cell clinic referring to itself as CIRM, some of us in the stem cell world already know of another CIRM, meaning the California Institute for Regenerative Medicine.
The stem cell clinic calling itself CIRM either (A) has little awareness about the wider stem cell world including the California state stem cell agency, or (B) has some wild idea of playing off the real CIRM.
I think it’s probably A, but these days, who knows?
The unproven stem cell clinic called CIRM goes by the longer name Center for Integrative & Regenerative Medicine and is located far from the real CIRM all the way over in Bangor, Maine. At the helm is chiropractor, Dr. Gerard Graves, D.C.
A HT to long-term reader “Bill Jones”.
The Center for Integrative & Regenerative Medicine says it offers Regenerative Medicine, Integrative Medicine, and Functional Medicine. Within the first category, they say, “Our stem cell procedures are comprised of stem cells and powerful Growth Factors that provide enormous healing and regenerative benefits. Our patients see tremendous results for a multitude of health issues.”
Combining stem cells with another biologic like growth factors probably creates a drug product requiring premarket approval from the FDA.
What kind of stem cells do they use? They say this:
“We use human umbilical cord-derived stem cells that come from healthy umbilical cords donated by healthy mothers and babies that choose not to save their cord blood for their own use. Our stem cells are carefully collected from thoroughly screened full-term umbilical cord tissue. They are minimally processed to preserve what’s valuable. Then they are cryogenically frozen in an FDA-registered lab. We adhere to the highest standards for handling by storing the stem cells in cryotanks in our office so that when it’s time for a patient to receive them, we ensure optimal vivacity of our product.”
They also give this hint about the supplier, “The donors for this tissue undergo extensive medical screening and provide a detailed medical history in order to ensure this practice is safe. Donated tissue is screened by the American Association of Tissue Banks and all procedures are held to the highest standards.”
So we are talking about allogeneic cells combined with growth factors, increasing the likelihood that FDA approval is needed. The site also suggests use of pulsed electromagnetic field (PEMF) may be helpful: “We strongly suggest corrective exercise while you are healing, which may include our PEMF technology to help super charge your cells during the process but not everyone will need this.”
PEMF, in my opinion, seems pretty iffy on its own. You can read about it here at Science-Based Medicine.
On the stem cell clinic contact page, they have in my view as a stem cell scientist this wrong answer to a key question:
“Can the cells be rejected or can I have a reaction?
In the decades that stem cells have been implemented, there has never been one case of rejection. That’s pretty impressive! The reason is that these cells are undifferentiated; this which means they do not contain HLA (Human leukocyte antigen which is used to match patients and donors) which means your body will not reject them. There is no debris like there is in placental or amniotic cells that could cause reactions – another reason why we use umbilical stem cells. The worst thing that could happen to you is some stiffness in the joint from the healing process or possible redness around the injection site. This is just your body’s natural healing process hard at work!”
Do your homework!
This news article is relevant here as well. It’s generally about the use of stem cells to supposedly treat autism in Panama including this passage attributed to Graves, “This is the closest thing to a magic bullet you can get.”
I have reached out to both California’s CIRM and this stem cell clinic to clarify things. The clinic has not replied, but here’s what CIRM spokesperson Kevin McCormack had to say:
“Well, they say imitation is the sincerest form of flattery, but somehow it doesn’t feel very flattering particularly as we spend a lot of time trying to educate people about the risks of going to clinics offering therapies that are not approved by the FDA. Thanks for letting us know about this. It’s clearly something we will be looking into.”
We’ll see if the clinic is still “CIRM” a year from now.
Then there’s that muddy waters documentary series I mentioned earlier on stem cells by Sarah Sheehan that seems oddly heterogeneous including people from all corners of the stem cell ecosystem. Erin Allday over at SF Chronicle has a helpful article on some of the back story to the controversial video series. Allday reports that many top stem cell scientists want out of the series. For instance:
“I am a stalwart and outspoken critic of unapproved stem cell therapies. I don’t belong in their company,” said Jeanne Loring, a professor emeritus at Scripps Research in La Jolla (San Diego County). She asked the filmmakers to remove her from the documentary after visiting the website, and they agreed to cut her out, she said.
“I’m fine with how I was portrayed in it,” said Loring, who was sent an advance copy of the episode she was in. “But I’d never endorse this sort of thing, and it’s implicit endorsement just being part of it.”
The SF Chronicle also has this bit on part of the funding of the video series:
“Sara Sheehan said the series was financed by a private group of investors but declined to name individuals. Dr. Mark Berman of Beverly Hills, founder of one of the country’s largest for-profit stem cell clinic networks, said he and his partner, Dr. Elliot Lander, helped with some financing. Their company, Cell Surgical Network, sent an email to patients last week promoting the documentary.”
Kristin Comella of U.S. Stem Cell also seems to be in the series.
Was Sheehan upfront with those filmed about who was behind the project and who else would be included? Allday’s article sure suggests that some of the folks didn’t know the scope of those who would be included.
Overall, the stem cell world can be confusing, especially for the general public. The events discussed in this post illustrate how muddy things can get.
Stem cell injections are beyond the scope of practice for chiropractors in Maine, so I wonder who is doing the actual injections.
Looks like they are back up an running again.
“Feel that burning sensation? That means it’s working!”
In trying to get to this other ‘CIRM’ site I now get “Account Suspended”. Looks like the real CIRM took some action…
I see that too now. Thanks for the heads up. That would be unusually quick, but it seems like a positive sign.
There are two ways I am aware of to get stem cells (dare I guess MSC?) from an umbilical chord: Explant culture (dissect and grow in culture) and enzymatic digestion, followed by cell sorting to select the MSC based on phenotype. As you stated, allogeneic cells which are more than “minimally manipulated” and not for homologous use. What would be considered homologous use of an umbilical chord cell? Three strikes, you’re out! All red flags which indicate these “therapies” would require IND application and Clinical trials.
“The worst thing that could happen to you is some stiffness in the joint from the healing process or possible redness around the injection site. This is just your body’s natural healing process hard at work!”
This is the cry of a quack. The worst thing that can happen is stiffness and redness at the injection site? Based upon what evidence? There are a handful of cases in the literature that say otherwise.
I’ll bet the stiffness and the redness are the patient’s immune system killing off the allogeneic cells, which is probably a good thing. I doubt that the study I would have to do to provide support for my statement would be ethical.
Sigh.