Last Friday I saw two patients for evaluation for possible stem cell treatment for painful knee arthritis. Both patients were on medications, had received multiple knee steroid shots, and one had even had one of the “gel” knee injections that go under the trade names like “Synvisc” or “Hyalgan”. One of the patients also had been prescribed an unloader brace but didn’t want to wear it anymore.
Both patients initially saw other clinicians for evaluation for stem cell therapy. One clinic used bone marrow derived stem cells and the other recommended either umbilical cord blood or amniotic fluid.
The lowest price was $7500 for one knee!
Because these novel procedures are not covered by insurance, clinicians are free to charge whatever they want.
For comparison….Medicare pays an orthopedic surgeon about $1387 in Dallas for a total knee replacement surgery!
To make matters even worse, the chiropractors and doctors selling patients umbilical cord blood or amniotic fluid as a stem cell injection are either committing consumer fraud…because there are no living stem cells in any of those products currently sold in the USA OR they are injecting people with a biologic drug that is not approved by the FDA ….because the FDA has approved NO amniotic fluid or umbilical cord blood products with living stem cells. So we can dismiss the clinics peddling amniotic fluid/umbilical cord blood from this discussion…..I would avoid them at all costs and save your hard earned money if the DC or MD or DO is selling one of these products as a living stem cell injection.
For the clinics actually using living cells legally…from either adipose or bone marrow sources…and it has to be from your own body (small exception for 1st or 2nd degree relatives)….what is the national average cost for one knee? We poll people that attend my training courses twice a year and the national average is about $5500 (a little less) for the procedure. So is $7500 too much for one knee? It is up to the patient to decide if the price and expected result is worth the cost. There are many situations where paying more for an item means the quality is better….but paying more may not mean a better result in this developing surgical subspecialty.
If the patient is getting the same $7500 procedure from a reputable doctor or surgeon only the cost is under $4000…then patients will have to be the judge 🙂
At the Dallas PRP and Stem Cell clinic we strive to educate patients first and then offer these orthobiologic procedures if and when there is a reasonable chance that the patient will benefit. Sometimes this means surgery is still recommended and we may add an orthobiologic injection. Most of the time our stem cell procedures are done in the office under ultrasound guidance in less than an hour!
Our cost? Under $4000 for one knee (or other joint).
We have seminars at our office that are free and designed to help patients wade thru the incredible amount of misinformation and false hopes spread on the internet and in the media. Our August, 2017 seminars are on August 10th and August 24th and 31st. Anyone may sign up by clicking below…hope to see you there!
Stem Cell Seminar Signup
Below is a link to an actual stem cell procedure….the patient is awake and talking during the procedure!
Hi Dr. Buford,
I work with several non-surgical Orthopaedic physicians who do BMAC treatments in regions that cannot support $5-$7k costs for Stem Cell Therapy. They typically charge $2.5-$3.5k for their Stem Cell treatments. Hopefully, when this treatment becomes more mainstream the government and competition will make it more affordable for the masses.
I agree Brandon that the cost is a barrier for many patients.
If “we” pay the proceduralist the same price that a surgeon gets paid for a bilateral partial menisectomy ($600)….and pay double the cost of the disposable to cover shipping and storage and inventory (call it $1500) and then paid for an expected 3 post procedure visits at $100 per visit (Another $300) and then a 15% percentage for overhead for office and employees and supplies…then you can see the total is around $2400 + 15% = $2760……I am basing the numbers on medicare payments and basic numbers that a non health care business would expect. So, if I had to bet….when and if insurance covers the procedure….it will hopefully be somewhere around $2800 …we will see….Even at $7,500 it would still save the insurance companies money overall by eliminating or delaying major surgical procedures!
Dr. Buford,
This is dead on. I actually represent Catalyst Regenerative Network. You have my card. We have a similar product except for one very vital difference not shown here sets us apart. you wont have to leave the sterile field to spin down the marrow to concentrate the marrow. It will increase the sterility or your procedure, minimize the wasted marrow, and cut out the most time consuming portion of the process. I would like to help you better treat your patients with a break through product for a treatment you are already familiar with.
Thanks for having a look Paul. The Marrow Cellutions is an interesting approach to aspirate Marrow and do a procedure without concentrating any of the non cellular components. I happen to think that things like IRAP and a2M and other biologically active growth factors in the bone marrow probably do have a role in the restorative process and there is no mechanism to concentrate those elements in only an 8cc draw with no centrifuging. Although CFU count is important….I have shown to my satisfaction in head to head tests on the same patient that using good aspiration technique and centrifuging leads to a significantly higher CFU count compared to good technique and NOT centrifuging to concentrate. When you throw in the additional benefit of concentrating the non cellular portion….I have to chose centrifuging for my patients at this point. We centrifuge to make PRP….why wouldn’t we centrifuge to make BMC? (total simplification I know) I have friends that use Marrow Cellutions and I will trust their results when they publish them…but right now there really isn’t comparison data on the Marrow Cellutions aspirate only product versus a lot of data on the BMC product. I have never had an infection with these techniques whether done in the office or in the OR (over the last 6 years) so although theoretically interesting…practically it is a non issue. In terms of time….Spins with commercial systems range from a short 90 seconds with ReInvent Biologics to 10 minutes for Emcyte to 14 minutes for Celling and about the same for Harvest and 17 minutes for Arthrex…so spin time should never be a decision that makes a doctor chose a solution….he or she should just pick the thing they think is best at this point. We still have a lot to sort out for sure….
Along with price there are a list of things patients should ask
in order to assess a clinic doing these procedures:
(In no particular order…and some have beendiscussed elsewhere)
1. who is doing the injection
2. exactly where are the stem cells coming from
3. what the published literature in humans suggesting efficacy for the condition being treating and the orthobiologic being proposed
4. what is the doctor’s experience with the procedure (both in terms of training and number of procedures done)
and more 🙂
I am asking about stem cell therepy for Parkinsons
I only treat orthopedic conditions with bone marrow derived stem cells (when using stem cells) so I have no experience with Parkinson’s disease.
Dr. Buford,
Have you looked at exosomes? These can cross the BBB. In addition, researchers just published the first human case study of exosomes for hip labral pain. Pain resolved, tear disappeared on MRI: https://www.dropbox.com/s/pls3byt272qsakt/HipLabralTearCaseStudy.pdf?dl=0
The number 1 issue with exosomes is that the FDA considers them biologic drugs and therefore they should be registered under section 351. However, every exosome maker and distributor has not done this. SO to use them in the USA would mean that I am using an unapproved biologic drug…puts my medical license and professional reputation at risk. I would never do that. There are drugs that are effective outside the USA and not approved here and I can’t use those either!
What are your thoughts on Liveyon and Utah Cord Bank products?
#1 I do not believe claims that any current amniotic fluid or umbilical cord blood company actually provides millions of functional living stem cells at the time their 1-23cc bottles are thawed in the doctor’s office and then injected into a patient.
#2 No company supplying amniotic fluid or umbilical cord blood products have any published human outcomes data comparable to either PRP or bone marrow derived stem cells for any orthopedic condition. When asked, these companies supply literature that is not relevant on the product they are selling…ie. culture expanded umbilical cord stem cells
#3 The avg cost (conservatively) of amniotic fluid or umbilical cord blood is $400-$800/cc depending on the company. The average cost of PRP for me is $45/cc. which means these birth tissue/fluid products are more than 8 times more expensive per cc with no outcomes data that is peer reviewed.
#4. The FDA has put in black and white the 4 criteria required for a product to be appropriately designated as a section 361 product under the PHS act. If these companies are telling the truth….then the fact they they are selling allograft living stem cells puts them directly in violation of the FDA edicts since an allograft product that has living stem cells and is not for a 1st or 2nd degree relative is actually a biologic drug and falls under the MUCH more rigorous section 351 regs. Neither the Liveyon nor the Utah Cord Blood bank products are correctly registered with the FDA as section 361 products IF they actually have living stem cells. If the companies DID correctly self-designate these products as section 361 with the FDA THEN they are marketing untruths to doctors and the general public who is paying for a living stem cell procedure but only getting a growth factor/cytokine shot that is less proven than PRP!
#5 Most of these distributors/companies are sourcing from same few tissue banks and just private labelling…..
$6 A company like Amniox Medical has similar or identical products BUT clearly does not make claims that they have living stem cells….they are being
transparent and honest in my opinion in this market…..and they are also spending time and money to study and define their product and indications.
Having just watched healing miracle
I’m confused. Several people had umbilical cord cells IV with great results yet you say and another site says they aren’t alive cells in the US and it’s fraud. So is it possible to get live amniotic fells injected ever?
ANY product with living cells used IV in the USA that does not have a IND (investigational drug application) approved with the FDA is in direct violation of current FDA regulations and using and selling an unapproved drug. The Healing Miracle series was an infomercial spearheading by a group of chiropractors who run the Stem Cell Institute Of America……and even that group has told all of its members…mostly chiropractors who then have nurses or others do the actual procedures, that should NOT use umbilical cord blood.
Is it currently not possible to get a living stem cell injection in the USA UNLESS the product is appropriately registered with an IND/BLA with the FDA. Since August, the FDA has acted against several of the people in the “Healing Miracle” but this was of course not disclosed. Mark Berman, Kristin Comella, Elliot Landers….all led or were affiliate with organizations that were raided or sent warning letters by the FDA to stop their current practices. In the case of US Stem Cell and Kristin Comella, several people were blinded by the actions allowed at their clinics. You can also google “Stemmimmune and FDA”. You can also google “American Cryostem and FDA” to see some of the recent FDA actions against people and companies in this business.
I’m 18 and have a torn Rotator Cuff and Labrum. I’ve had two surgeries so far and in need of a third. It’s been 5 or so years since I’ve competed in any sports(due to the injury) would any doctors recommend this treatment?
With the history that you have given it seems very important that you have a surgical consult with a shoulder specialist. Without knowing more history and seeing MRI scans and doing a physical exam I really couldn’t comment further on your specific condition. It is very unlikely that any stem cell procedure would repair a torn/displaced rotator cuff tear….but this is not a medical opinion on your specific condition. If you want to come to our clinic I would be happy to evaluate you and give a both a surgical and regenerative medicine opinion. I have done over 2000 rotator cuff repairs in the last 18 years….all arthroscopically…so I think we could at least point you in the right direction. Don Buford MD. drdonbuford.com
Hello Dr Buford hope all is well.
I have a few questions of which I’m not sure of, 5-6 years ago i had my acl reconstruction done using a hamstring graft but 2 years back i tore my meniscus in the same knee and had to get it operated again. After both my injury i never could get back to sports my knee feels very weak when i try to workout and strengthen it but It feels like my patella tendon has gotten weak or im not sure what. I read alot about PRP and amniotic injections and would considering doing it if it gets me back to running and getting back to sports (considering sports stars like kobe bryant etc) i am only 25 years old and would do anything to get my knee back and well and be able to play sports again like i used to. I Would really appreciate if you could provide some opinion based on your massive experience.
Hello, we aren’t allowed to comment on specific cases or make specific recommendations in this forum. In general orthobiologics can be a useful treatment tool for patients with sports related injuries and after some sports related surgeries. A doctor who understands the surgery you have had, who can make an accurate current diagnosis, and who has experience with orthobiologics and surgical options might be the best for you to consult at this point since it sounds like you have had a difficult time with your knee.
Hi Dr.Buford, what are you thoughts for stem cell therapy offered in panama for autism? They have their own lab to procure MSC from donor UC.
I only treat orthopedic conditions because that is what my specialty is. If I were exploring that I would want to see many published human outcome studies in respected peer reviewed journals using the technique proposed by the clinic before even considering it for a family member. I haven’t seen that kind of data.
Dr. Buford,
What is your opinion about Exosomes and Huk (I think that’s the proper spelling) cells and their use in Orthobiologic procedures? I’m a physician and a doctor friend of mine was asking me about them. Are they legal to use in the U.S.? He has a rep from the company Catalyst who is pushing them and telling him that these products are just as effective to use as PRP or BMA or an Adipose derived procedure. My research tells me differently. Anyhow, if they aren’t legal to use in the US, then how is this company able to pedal them to unsuspecting doctors? If my friend takes delivery of said products is that a problem for him? How would you convince a physician friend to stay away if what I suspect is correct is in fact correct? Thanks
Exosomes are produced locally in response to the specific local environment…ie. if a joint is inflamed, the local exosomes being produced may have an anti-inflammatory nature overall. This process is largely overseen by mesenchymal stem cells in the local environment. Having off the shelf exosomes is problematic to me because I have no idea what the MSCs that produced them were being stimulated by….maybe the exosomes in the bottle are not at all what needs to be produced for the clinical situation….exosomes for tendinopathy may be very different for exomsomes for knee arthritis for example. Combining that huge issue with the lack of any clinical data of additional benefit from exosomes over PRP or even bone marrow derived stem cells and now I have two reason NOT to jump on the exosome bandwagon yet. The third reason is that at $1000+ dollars for a 1cc vial it is by far the most expensive orthobiologic to date being sold for clinical use…..again with no human outcomes data in orthopedics to my knowledge and no assurance that the single bottle of “exosaomes” its even the right formulation for the patient’s specific clinical situation…..In my opinion I need a MSC to respond to the local environment and product the relevant exosomes organically…and we are still proving up that before trying to customize and off the shelf exosome product.
For immunocompromised patients and Geriatric patients would exosomes be a favorable product over BMA? Seeing that they are non-autologous?
Exosomes have no research proven benefit in orthopedics in humans and are problematic for many many reasons.
#1. Exosomes are produced by cells in response to the local environment. What exosomes are produced is totally dependent on the local joint environment (to use an arthritic knee as an example) .
#2 “off the shelf” exosomes are not produced for any specific joint environment…in fact…we have no idea what the environment was for the cells that produced the bottled exosomes….a total non starter right there for me…I can’t put something in a patient without knowing that it won’t actually be negative…..exosomes could be very negative.
#3 I use either PRP because it autologous and safe, or bone marrow derived stem cells because these living cells can then produce the specific exosomes needed for the specific location and environment they are put into.
#4 I have been offered a 1cc vial of undefined exosomes for $900-$1500. A ridiculously high price for a potentially dangerous allograft product with no scientific outcome.
PS
*The FDA just had a nationwide recall on a different allograft product…an umbilical cord blood product…produced by Genentech and distributed by Liveyon….because of E. coli bacterial contamination…..the risk of allograft products is real…and you can undue some of the harm sometimes….not worth it when there is a proven cheaper autograft safe product available.
There is nothing to suggest that in the quantities typically harvested for bone marrow that the immune response is significantly affected. There is a lot of data supporting the fact that bone marrow derived stem cell therapy for various orthopedic indications is successful well into the mid 80’s. You can google Philioppe Hernigou’s work…some of his work is on elderly patient populations with equivalent positive outcomes to younger populations.
Dr. Buford,
What are your thoughts on Wharton’s Jelly? We are having great success with this product.
Bill Joeckel
Based on the FDA rulings in following “cases” I don’t think that Wharton’s Jelly meets FDA regulations to be under section 361. This means that if I were to use it on humans, I would be using an unapproved biologic drug that does not have an IND/BLA or a RMAT designation to allow current sale and use in humans. Since it is an allograft tissue (and often sold as a stem cell injection with living cells)….it has be used in a homologous way to satisfy one of the FDA section 361 criteria. Simply printing on the label “for homologous use” does not satisfy that criteria.
There are 4 examples I will give on the best guess at FDA opinion on any birth tissues being used in orthopedics are as follows: (1) In 2018, The FDA opined in the Genetech/Liveyon case that umbilical cord blood/tissue was not homologous use in orthopedics (2) On 3/29/19 in a Warning Letter to the Cord For Life company, the FDA reaffirmed that umbilical cord blood/tissue was not homologous use in orthopedics (3) Mimedx presented an amniotic based product to the FDA to get approval to sell and use it in humans specifically for knee arthritis. The FDA granted MiMedx a RMAT designation ….and as a result Amniofix is under study and is appropriately regulated for sale and use in humans as an allograft product not being used homologously (4) In The 2017 Guidance Documents published by the FDA, the FDA even stated that AUTOLOGOUS (ie. from the same person) adipose tissue was NOT homologous use in orthopedics As a bonus bit of commentary…..no Wharton’s Jelly product on the market has been sent to the FDA to get confirmation of section 361 classification or regulatory approval …..this is a process that is exceedingly easy and available with on line instructions from the FDA itself. You have to ask yourself why no company has done this…..and whenever any birth tissue product has been evaluated by the FDA in orthopedics…it has been deemed non-homologous.
the Genetech/Liveyon
And of course, there are additional issues with Wharton’s Jelly. PRP costs me $30- $40 per cc. How much does Wharton’s Jelly cost on average per cc? Usually it is at least 10 times to 30 times more expensive for a product that has never been studied in comparison to PRP for the orthopedic applications I uses PRP for.
Finally, there have already been two major studies (Alan Hirahara, Brian Cole, Lisa Fortier are all authors, et al.) released this year showing a lack of living, functional stem cells in any birth tissues products frozen and shipped to a doctor’s office to be thawed….so if there are no living stem cells then the comparison is valid to PRP which also has no significant living stem cells…..and with that comparison Wharton’s Jelly is crazy expensive with total lack of human’s outcomes data, with no PRP comparison data, and with no proof that it is indeed being sold legally as an allograft birth tissue product.
I just can’t take any risk for any a product when I can make PRP in 8 minutes from the patients’ own blood for $30-$40 per cc, with no FDA problems and with tons of human published studies for most ortho applications….
So far you are the only Dr. That i have seen that has put everything out there for people to see. Thank you for the time you have taken to spread your knowledge.
Thanks Paul! I try to present ALL the medical and surgical options for my patients when doing informed consent. I tend to pick the most effective, longest lasting, easiest, cheapest, most proven options (it is fantastic when one option meets all those criteria….sadly there are usually pros and cons to several good choices)