Yes — but it depends on the therapy and how it's offered.

In the United States, all stem cell therapies are regulated by the U.S. Food and Drug Administration (FDA) as biologics. Only a limited number of stem cell treatments are fully FDA-approved for specific medical conditions. For example, stem cells derived from umbilical cord blood are FDA-approved to treat certain blood and immune system disorders, such as some cancers and inherited blood diseases.

For most other uses — including regenerative applications or neurodevelopmental conditions like autism — there is no FDA-approved stem cell therapy yet. The science is promising, and research is actively underway, but these treatments are still experimental and investigational.

Stem cell therapy for autism is not currently FDA-approved as a standard medical treatment, which means there is no marketed, approved stem cell product specifically for autism in the United States.

However, the Right-to-Try Act is a federal law that creates an additional pathway for patients with conditions with no remaining FDA-approved treatment options — to access certain investigational drugs or biologics that are being tested in clinical development and have completed at least Phase I safety testing, without being part of a clinical trial and without waiting for full FDA approval.

In practice:

• Right-to-Try does not require FDA approval or involvement in the application process.
• A patient's physician must certify that approved options are exhausted and that the patient isn't participating in a clinical trial.
• The treatment requested must be an investigational drug/biologic that has passed basic safety evaluation (e.g., Phase I).

BetterStem uses the Right-to-Try pathway to extend access to investigational stem cell therapies being studied for autism to eligible families who are not enrolled in existing clinical trials. These therapies remain investigational, and participation under Right-to-Try requires informed consent and physician oversight, but it does not require the family to be enrolled in a specific clinical trial to access the same investigational products.

Umbilical cord stem cells help reduce inflammation in the brain, which is common in children with autism. They also promote healing and support the creation of new neural connections. This can lead to improvements in language, behavior, focus, and emotional regulation.

Yes, the treatment is generally very safe. There are no known long-term side effects from using umbilical cord stem cells.

• In rare cases—about 2% of children—mild, short-term effects like low-grade fever or a light rash may occur. These usually pass within a day and are easily managed with over-the-counter medication like Tylenol or Benadryl.
• Around 20% of children may experience a temporary increase in certain behaviors—such as aggression, hyperactivity, or stimming—typically for a few weeks after treatment. This is not uncommon and always returns to baseline. In fact, most children see significant improvement shortly afterward.

No, there are no known long-term risks associated with umbilical cord stem cell therapy. These cells have been used safely for over 60 years in treating more than 80 diseases that is approved by the FDA. The product is carefully screened, and the safety profile is excellent.

We use FDA-regulated, minimally manipulated umbilical cord stem cell products. That means we do not expand, multiply, or alter the cells in any way — ensuring they remain as biologically safe and potent as when they were originally harvested from healthy live birth, ethically donated, full-term births. Every batch is rigorously tested for all sources of diseases, sterility, viability, and potency. Every vial comes with a Certificate of Analysis.

People of every age can benefit from stem cells therapies.

Many studies show that children with autism have significant brain inflammation. This has been confirmed through spinal fluid testing, PET scans, and even autopsies. While inflammation isn't the only factor, it's a major one—and it's something we can treat medically.

The stem cells are administered through intravenously (IV). Once the IV line is secured, we will run some saline, bring the stem cells to room temperature and then inject them directly into the IV line or IV bag. You can expect the entire appointment to be about an hour.

Dosage is based on your child's weight. Our IRB-approved protocol uses a minimum of 2.5 million MSC stem cells per kilogram of body weight.

We never know in advance exactly how many treatments will be needed. We don't recommend more than one treatment until we've seen the results from the first, and ongoing outcome monitoring after that treatment helps our medical team determine the most appropriate recommendation for any future treatments.

The entire visit usually takes about one hour. That includes meeting with the doctor, reviewing the plan, and completing the treatment.

About 65–70% of children experience meaningful improvement after stem cell treatment. Some see dramatic gains in speech, focus, or social interaction. Others improve more gradually. Every child is different, but the potential is significant.

Improvements may include better speech, increased eye contact, improved focus, reduced aggression, and less anxiety. Some kids start talking more, others sleep better, or engage more socially. Results vary, but many families see life-changing benefits.

Results are variable. We have seen results in as little as a few days, but it does take some time for the cells to set up residence in the body and start producing exosomes. We believe a reasonable time frame is 2-4 weeks but could take up to 2-3 months. Please note that results are not guaranteed, while 65-75% of people do see improvements, not everybody benefits.

Studies show that improvements in autistic symptoms typically begin around one month after treatment and continue to increase over the following six months. Around the six-month mark, progress tends to reach a plateau — meaning the gains stabilize — but importantly, there is no regression. This suggests that the benefits of treatment are sustained over time, offering long-term improvements in areas like speech, behavior, focus, and emotional regulation.

Yes. Many parents report a noticeable reduction in anxiety after treatment. Children may become calmer, less rigid, and better able to handle transitions or frustration. This is likely due to the stem cells reducing brain inflammation and improving communication between brain regions.

No, it can help teens and even young adults. While younger brains tend to be more adaptable, we've seen significant progress in older children too—especially in areas like anxiety, social interaction, and executive function. Every case is evaluated individually.

Yes. Many children on the spectrum experience increased aggression during puberty due to hormonal changes and brain inflammation. Stem cell therapy can help reduce inflammation and improve emotional regulation, often leading to calmer behavior.

Stem cell treatment may offer some benefit for children with genetic syndromes, particularly when inflammation or detoxification issues are involved. While research is still early, some families have reported improvements. Each case should be reviewed carefully with our doctors.

No, blood typing isn't necessary. All red blood cells are removed from the stem cell product. The remaining solution contains only the active stem cells and plasma, making it safe for all children regardless of blood type.

No, we cannot use personally stored stem cells.

Yes. Most families fly home the next day. If you need to travel the same day, we recommend scheduling the treatment in the morning so there's a few hours of observation before your flight or drive. There are no travel restrictions after the procedure.

The total cost depends on your child's weight and the number of vials needed. For smaller children, the cost ranges around $10,000, and for older or heavier children requiring more cells, total treatment can range into the mid- to high-$15,000s.

Currently, insurance does not cover umbilical cord blood stem cell therapy for autism, as it is still classified as an investigational treatment in the U.S.

However, we do offer flexible financing options through our financing partners. Depending on your family's eligibility, you may be able to pay for treatment over a period of up to 36 months, making it more accessible and manageable.

The FRAT test (Folate Receptor Antibody Test) is a blood test that checks for antibodies that block your child's ability to absorb folate, a critical nutrient for brain development and cellular function.

About 60% of autistic patients have autoantibodies to the folate receptor, making the incorporation of folate into the cells impossible. Folate is especially needed in brain cells for adequate function. Folinic acid (Leucovorin) enter the cell through a different mechanism, is converted to folate, and then folate metabolism can proceed normally. Multiple blinded placebo-controlled studies exist demonstrating benefit of folinic acid in this population.

If the test is positive through the FRAT test, we prescribe folinic acid (Leucovorin), a medical-grade supplement that bypasses the blocked pathway and helps restore normal brain chemistry. It's often used in combination with stem cell therapy to enhance cognitive and behavioral outcomes.

If parents would like to have this test performed, we provide a physician order to the parents to purchase the test online. Once ordered, the kit will be shipped to your home. Bring the kit with you on the day of the stem cell procedure — we can draw the blood sample at the same time, making the process easier for your child.

The gut health test is a simple urine test that checks for gut dysbiosis—an imbalance of bacteria in the digestive system. About 80% of kids with autism have it, and it's linked to behaviors like anxiety, aggression, and hyperactivity. Treating gut dysbiosis can improve outcomes and make stem cell treatment more effective.

The test can be purchased online at www.analutos.com, perform the test, and mail back to the laboratory.

If gut dysbiosis is confirmed, it can be treated in a fairly simple way. Dysbiosis is treated with FMT (fecal microbial transfer), a simple procedure that includes oral antibiotic and anti-yeast that are not absorbed and stay in the GI tract; followed by oral microbes for 3-4 months. The results are amazing in early studies (95% reduction in gut symptoms, 47% reduction in autism symptoms).

Not always—but they help personalize the treatment plan. If blood draws are difficult, we can draw blood for the test right before administering the stem cell treatment.

Simply call us or schedule a free 15-minute consultation. During this call, we'll review your form and discuss your treatment options in detail.

Tests are not mandatory, but we highly recommend them to help our medical team accurately evaluate your condition and determine the most appropriate treatment plan

Yes! We offer free financing with no interest or hidden fees through our trusted financing partners. The application process is simple, and approvals are typically issued in real time, making it easier for you to move forward with care.

A deposit is required to hold the appointment, and the remaining balance is due 2 weeks prior to the procedure date. A deposit is required to hold your appointment, and the remaining balance is due two weeks prior to the scheduled procedure date