Live Umbilical Cord-Derived Stem Cells | Are They Legal in the United States?

In this video Dr. Travis Whitney discusses the legality of live umbilical cord-derived stem cells. These particular stem cell treatments are legal in the United States due to several factors, primarily centered around regulatory approvals and clinical applications. These stem cells are obtained from donated umbilical cord blood or tissue, which is typically considered to be minimally manipulated and poses lower risks.
In the United States, the Food and Drug Administration (FDA) regulates stem cell therapies. Umbilical cord-derived stem cells fall under the category of minimally manipulated autologous stem cells, as they are often derived from a person's own umbilical cord or donated cord blood. This categorization means that these stem cells are generally considered safe and not subject to the same rigorous regulations as more complex, drug-like therapies.
Umbilical cord-derived stem cells have been extensively studied and proven to be effective in treating a range of medical conditions. They have been widely used in clinical settings, particularly for bone marrow transplants and in the treatment of blood-related disorders. The established medical and scientific community's recognition of their efficacy contributes to their legality and accessibility.
Despite the legality of umbilical cord-derived stem cell treatments in the United States, many people believe they have to travel overseas for treatment. Due to the complexities of stem cell therapy regulations, there is often misinformation in the media and on the internet. This can lead people to believe that stem cell treatments are only available outside of the U.S., which is not the case at all.
While some stem cell clinics and labs have been approved and are in use in the U.S., many commercial labs have various restrictions and guidelines they have to follow. This leads some to explore overseas clinics that may offer experimental or unproven stem cell therapies for a wider range of conditions. The live umbilical cord mesenchymal stem cells we use however, have proven to show excellent viability and amazing results in proper treatment settings.
While live umbilical cord-derived stem cells are legal in the United States, the perception that overseas clinics offer unique or superior treatment options may persist due to a combination of misinformation, expanded treatment options, and cost considerations. It's crucial for individuals considering stem cell therapy to thoroughly research the available treatments, and consult with reputable medical professionals.
To find out if regenerative stem cell medicine can help you or a love one, call Innate Healthcare at 602.603.3118 or check out innatehealthcare.org
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[@jamesbentz7883]

Hi Dr Whitney, Nurse Jim from Las Vegas here... thank you for this explanation on the legality of using expanded stem cells for the treatment of your patient's here in the United States. Wonderful.

[@neilmcmanus3727]

thank you for the videos on all aspects of MSCs, legality is a very important subject.

[@guitarsz]

Hi Dr. Travis, REALLY appreciated you addressing this in your video. I have a couple of questions 1) why would other clinics decide to go to other countries to practice similar treatments if they did NOT plan to market their stem cells for distribution? What would make them do that, if like yourself they could stay within the US? 2) what types of test do you run on your MSC to check for efficacy to make sure that they will action "do" or secrete the properties that a patient would hope to acquire when paying for them. In other words, not all MSC are created equal...so how do you distinguish quality over quantity?

[@InnateHealthcareInstitute]

Thank you! I'm not sure, I guess only those clinics could answer that 100%. Maybe they think they could make more money having an overseas clinic. Maybe the don't want the risk of having the FDA or other organizations investigating them in the US. Maybe it's easier for them to operate in another country. Maybe they don't understand the laws in the US so just go to another country. Flow cytometry, viability, population doubling times, and of course clinical results allow us to extrapolate that the cells are secreting properly, there's an ELISA that can capture exosome expression but we haven't used that, yet. There's a cytokine secretion assay we could do as well, but it's very research oriented. We haven't found commercial services that assess for that.

[@guitarsz]

@@InnateHealthcareInstitute Thank you so much for your reply Travis!

[@jennifercarillio8403]

Has to do with how much one expands the MSCs as well as completely following regulatory guidelines as far as disease control.

[@jennifercarillio8403]

Yes, I'm glad you put out this video explaining that msc umbilical derived stem cells ARE legal.....under the correct FDA approved guidelines. I think the USA is not allowed to expand as much as other countries, though. If expanding too much, you have less efficacy in the regenerative processes.

[@traviswhitney8482]

Expansion is up to the doctor/lab/clinic etc. Yes too much expansion isn't healthy for the cells, no matter what part of the world you're in.

[@jennifercarillio8403]

Do you have any experience with facial nerve patients and Trigeminal damaged individuals​@traviswhitney8482

[@user-uq4fv7cc1r]

Thank you Dr. Whitney for great explanation with details. I am wondering Where do the clinic obtain umbilical tissue? are there FDA guideline to obtain tissue? or is it Tissue or cord blood? Thanks.

[@InnateHealthcareInstitute]

Cords can be acquired for research purposes from cord banks and certain hospitals. There are FDA criteria fro storing and banking cords.

[@michaelamiras9727]

Hi Dr. Whitney, Do you do UTZ quided shoulder injection ?

[@InnateHealthcareInstitute]

We can do ultrasound and fluoroscopy for shoulder injections

[@wferg1121]

Hi Dr, my wife has early onset alzheimers frontemporal, her first signs we went to the dr for memory and were dismissed as getting older, her second symptom was hallucinations took about 8 months for a diagnosis, that started on 11/20/2021 right before her 47th birthday. In her current state she says nothing is wrong with her, if I brought her in and we start talking about her, she is liable to flip out. I think for her she would have to be put under some sort of anesthesia or be restrained. Is that something you would do.

[@InnateHealthcareInstitute]

Hi @wferg1121, it would be hard to understand completely the extent of your wife's condition through text. The best thing to do would be to call the office and speak to one of our incredibly qualified doctors, [phone]. Or visit the website where we feature accessible information and an extensive FAQ and library, InnateHealthcare.org.

[@PrattPropertiesTeam]

Hello I just had stem cell intravenous in DR and he says I should return in 6 weeks is this correct? I did it for youth beauty and anti-aging - just want to know how necessary it is to return so soon

[@InnateHealthcareInstitute]

Every doctor is going to have their own recommendations. Having another IV 6 weeks later isn't necessarily "too soon", but you have to weigh each persons availability, finances, personal schedules etc. The DR seems like a long way to travel for IV stem cells, unless you live in south Florida maybe.

[@PrattPropertiesTeam]

What do you charge for IV stem cells?

[@InnateHealthcareInstitute]

You'd need to talk to one of our doctors to see if the treatment is an approved option. But prices can average from around $10,000 for hundreds of million of UC-MSCs to $26,000 or higher for billions of UC-MSCs. Patients work with their doctor to decide a dosing schedule.

[@dudejoyce]

So only the rich cam get help is what is happening

[@bendungee1669]

I know you can get stem cells in the USA, but your explanation made it more confusing now. I am not sure which part is suppose to be illegal by your explanation. Made redo the video. Both examples had expansion of stem cells, and selling to a MD or clinic basically. It’s the expansion and growth factors used from understanding that makes it illegal.

[@InnateHealthcareInstitute]

What part are you confused about?

[@100goodheart]

Autism stem cell cost?

[@InnateHealthcareInstitute]

Typically between $11,500 to $26,000 for 3 to 12 treatments. This link will help innatehealthcare.org/stem-cell-therapy-for-autism-faq/