At the end of March 2021, my third child participated in a clinical trial at Sheba Medical Center in Israel. The clinical trial aims to find out the effect of a cord blood transfusion for autism or cerebral palsy. My son is diagnosed with autism spectrum disorder. I am hoping to see improvements in his communication. The treatment has the potential to give him improvements in balance and motor skills as well. In this post I will describe the cord blood transfusion at Sheba MC.
Participating in a clinical trial in Israel to test the effect of cord blood on autism
Our story with the cord blood begins years before we even had children, when Shira was a neonatal nurse at Sheba.
In one of the hospital courses for neonatal nurses, a local cord blood bank “Taburit” gave a lecture about cord blood and their work. Shira was later invited as a neonatal nurse to Taburit’s convention where Professor Joanne Kurtzberg was invited to give a lecture about her clinical trails on the effects of cord blood for autism, cerebral palsy, leukemia and more.
Following that lecture, Shira explained to me the importance of preserving cord blood. Unfortunately, this is very expensive. At the times our eldest and second child were born we decided not to preserve. Fortunately the price in Israel has gone down. The local HMOs take part in the expenses.
When our third child was born, our eldest was just a few months after his autism diagnosis. Since we already knew about the Duke clinical trial, we thought we will have a use for his cord blood for our eldest’s autism. We would have preserved it even at the original cost.
The clinical trials at Duke University allow the use of siblings cord blood. Our first attempt at using our third child’s cord blood was for our eldest’s autism.
However, the clinical trial at Duke has a very long waiting list. The cord blood unit we had, was not going to be big enough. Eventually our eldest received MSC stem cells, in Russia. A similar procedure in terms of medical treatment and expected outcome. He had very good results for both autism and epilepsy.
Eventually, our third child was also diagnosed with autism. As soon as the clinical trial was opened at Sheba, we signed up. We started on August 2020. Each participant goes through two rounds, and we are currently after our second.
Arriving at Sheba Medical Center for the clinical trial
The clinical was approved to open at March 2020. As soon as it did we immediately filed our papers to register our third child. We already had nearly everything prepared, since we had the paperwork prepared for the registration of the eldest in the Duke trial. Our eldest couldn’t be entered at the Sheba trial since it doesn’t accept sibling cord blood.
We had some additional testing to do, and filed all the paperwork. After we received, approval to start, and a date, we did the first round in August. The first round was basically the same as the current one. (I hadn’t translated that post yet.)
Some of the stages repeat themselves. The administration day repeats twice. Once with a placebo and once with the cord blood. In this manner, the researchers create a control group. This is a necessary requirement for quality clinical research.
This research method is called Double Blind. In this method each participant knows they receive the real treatment. Otherwise we wouldn’t want to enter such a trial.
After receiving approval to participate, the next stage will be a developmental assessment. Autistic children will need to have their communication skills assessed. CP children will need to have their motor skill assessed.
As we have an autistic child he had his cognitive and communicational skills assessed.
We entered one of the offices. He was asked to solve some puzzles, and answer some questions. He was shown some pictures to recognize. It wasn’t too bad, but he had a hard time sitting in the room for long. The research consultants played some games with him. They also raced in the hallway to help him focus.
We also received a questionnaire to fill out at home, and return in the next session.
Cord blood or placebo transfusion
About a week after the assessment, we returned to the hospital. We received the cord blood or the placebo.
Since this was our second round, we did the assessment again, and received another transfusion. If the first transfusion was the placebo, this time we got the cord blood. The syringe is covered so we won’t be able to guess its contents.
Mental reinforcement as preparation for an injection
In order to make things smoother for our child, we prepared a social story. We gave a copy to his kindergarten as well. We read him the story everyday about two weeks in advance. (Contact us if you need a copy of this social story)
Entering the nurse’s office to draw blood was still difficult. He is young. But knowing how the day will look like helps a lot.
The story visually describes the daily schedule. Knowing what to expect helps with waiting a long time too.
We arrived early in the morning, at 7:30am. The research consultant greeted us and made sure we know what’s the schedule. She introduced us to the medical staff, and made sure we were comfortable.
First stop – blood tests
The first stop after arrival was the nurse’s office. He was very worried about getting a needle injection.
He was weighed, and his height was measured. The nurse drew blood for a blood test. She left the intravenous cannula in his hand. This will later be used to transfuse the placebo/cord blood unit.
After leaving the line in his hand, we had to wait a few hours. The cord blood needs to be defrosted and prepared for the transfusion. This takes a while, and they can’t prepare it in advance. If anything happens it might go to waste.
The placebo doesn’t need as much preparation, but it is given at about the same time to give the impression of the real deal.
So we waited a few hours. We watched TV, played some games, and had some snacks. We were resting on the hospital bed as the staff brought the transfusion unit.
Cord blood / placebo transfusion
The cord blood or placebo comes in a large covered syringe so we don’t know what he’s getting. The syringe is marked so we’ll know it’s his. We signed some paperwork that we agree to transfuse the unit and some medications.
The nurse attached the syringe, then covered everything with a cloth. This is so we don’t see the color of the fluid as it goes through the tubes. It was all very exciting.
The nurse started pushing on the syringe. In a very anticlimactic minute or two it was finished.
We had to wait around another couple of hours to make sure he doesn’t have any adverse reactions. And we returned home.
Three days after the transfusion we went back to the hospital. They took another blood test. This is to monitor that the cord blood was accepted. As a result of a real cord blood transfusion, stem cells will be see in the blood test.
About half a year after the second round we will be asked to return for another follow-up. And that’s it.
What is the expected effect of cord blood for autism or CP?
When cord blood is given to a child for autism, the researchers expect improvements in communication. CP children will be expected to improve in mobility.
Since my child is autistic, I would like to see the improvements in his communicational skills. For example, that he will have less echolalia. I hope he will do better in social understanding.
From the experience we have with our eldest’s results, I can also hope for other skills to improve. For instance, his balance and motor skills could improve. His sensory processing issues could also decrease. And much much more.
Adverse side-effects from a cord blood transfusion
This is not a medicine, and since it’s his own tissues being returned there shouldn’t be any adverse side-effects. However, cord blood is cryo-preserved. As a result of the preservation process there might be a reaction to the preservation chemicals.
When the cord blood is defrosted and prepared for a transfusion, The chemicals are washed out. But there will always be some left in the blood. This is the reason we had to stay in the hospital after the transfusion.
Another side-effect that is well documented is a period of increased hyperactivity. Many parents on stem cell Facebook groups report this effect. That for a few weeks and up to about 8 months their child was intolerable.
I am not worried about this happening, because I understand this is a representation of the stem cells activity. Whether or not there will be increased hyperactivity, it will pass within a few months.
Finally, if the effect of the cord blood on my third child is similar to the effect of the stem cells on my eldest, I also expect to see some temporary behavioral regressions.
Temporary Behavioral Regressions
My eldest had his first stem cell therapy (SCT) two years ago. The clinic in Russia suggested we have up to five SCT six months apart. Our third session was in March 2019, just as the pandemic hit Israel and Russia. We are aiming to return to the Russian or Serbian clinic in the summer.
During the period six month periods after the treatments he had incredible leaps in behavioral development. During these periods there were also temporary behavioral regressions. It felt like his development was running to catch up, and then suddenly came to a halt. Each time for about a week he would regress just a little. It was quite frustrating, but after a few days, he would rejoin the race.
If the same effect happens with cord blood, I will no be worried. I realized that the regressions are a part of the process that leads to surprising results. If he starts hitting again as he used to, he will probably have a quicker time learning that he is expected to behave more calmly , for instance.
Some background on cord blood for autism and cerebral palsy
In the late 80s, Professor Kurtzberg discovered the potential of cord blood when one of her patients was transplanted with his sister’s cord blood. Following the transfusion, her then 5 year old patient recovered from Fanconi Anemia. This led her into research on the potential of this treatment for other conditions.
From there, Kurtzberg started focusing on the potential to help children with CP and autism.
Her research showed that children with cerebral palsy can have significant improvement in motor skills.
Under certain conditions children with autism had significant improvements in communication. Autistic children with normal or higher IQ (>70), and with a minimal cell count in the cord blood unit (above 20 million cells per child’s weight in kilograms). Improvements were most significant in children between the age of 3 to 7 years old.
Expanding on the research
The fact is that Professor Kurtzberg wasn’t the first to research stem cell therapy. However, her name has become prominent and she is considered the guru of stem cell research. Many stem cell clinics refer to her for consultation.
As a result of her publications, the stem cell research field has expanded increasingly fast. It has since expanded to many more clinical research fields in other countries. Even here in Israel, there are more than a few clinical trials that look into stem cell potential in governmental hospitals and private companies.
On top of cord blood, there are many more sources for stem cells. These are employed in regenerative medicine for more and more conditions. This allows patients to obtain stem cell therapy even without cord blood.
In Israel the stem cell treatment field is still really still in infancy, but there are more and more options and advances all the time. Sheba Medical Center’s cord blood research opened in 2020. If it’s results will show that cord blood significantly improves the condition of autism or CP children, it will probably expand the research into additional fields in Sheba and other Israeli research centers.
How to enter the cord blood for autism or cerebral palsy clinical trial
The clinical trial entry conditions are similar to those in Duke. There are other research centers around the globe that accept patients under different conditions. If you do not meet the entry conditions or even have a unit of cord blood, it might be worthwhile to expand the search.
Sheba clinical trial entry conditions
The Sheba clinical trial is at its first stage, and only accepts Israeli residents. First stage clinical trials aim mainly to prove that a procedure is safe. There is only room for about 30 patients, but since the entry conditions are very limiting, there are still spots available. *At the time of writing the article.
Autologous cord blood
This clinical trail accepts only patients that have cord blood that was taken at their own birth. Sibling or donor cord blood will not be accepted at this stage. Dr. Bar-Yossef applied for a sibling cord blood trial as well, but it was not approved.
Some clinics accept sibling or donated cord blood for autism and other conditions.
Minimal cell count and clean cord blood unit
The Duke cord blood for autism/CP has already established the minimum unit size for results. Any cord blood unit that is too small will not be accepted in the trial. It also must be clean from any viral, bacterial or fungal infection.
Contact your cord blood bank to send you the preserved unit information. The document should detail the cell count, and that the unit is clean from any infections.
Calculate if your cord blood unit has the minimal amount of cells before applying to save yourself the effort:
Look at the document and locate the cell count. It will usually be a three digit number with an exponent. You can ignore the exponent for the calculation. In the example below the important number is 386. Divide that number on your cord blood document by your child’s weight in kilograms. The result should be bigger than 20.
For example if your child weighs 15kg: 386/15 = 25.7 . This is more than enough to enter the research.
But if your child weighs 20kg: 386/20 = 19.3 . Since the result is less than 20, the child will not be accepted to the research.
The research team will access the candidate’s medical history. They are looking for any background illnesses that could skew the results of the study. They will also look for medical conditions that would put the candidate at risk from the transfusion.
For example, if a child with autism also has epilepsy, there might be a relief of seizures. (Such as what happened with my eldest). It would be impossible to attribute the developmental improvements only to autism. This would be an excellent outcome for the child, but useless for research purposes.
If the candidate has cancer for example, the transfusion would put him at risk. The stem cells might act as growth factors for the cancer tissue.
The Sheba trial is open to children up to the age of 12 years old. If your child is older but there are still enough cells in the unit, it is worthwhile to check other clinics. Check out our clinic recommendations page (will be translated soon).
How to Register
If your cord blood and child meet all the requirement, send your documents to the trial email: (email was removed as the Sheba clinical trial is currently not actively recruiting candidates).
*Unfortunately at the time of writing the post the clinical trial was still recruiting candidates. At this stage the Sheba clinical trial is no longer looking for candidates. This leaves the option of registering for clinical trials at other countries. Go to our clinics recommendations page to look for our list of private clinics and clinical trials. Go to clinicaltrials.gov to search for trials that are actively recruiting.
Alternatively, we will be happy to offer our services to help to you find the right clinic/trial. Please fill out the contact form.
When we finish our obligations to the trial in about six month, we will hopefully report on the incredible results we might see in our child. It is possible that he will not have significant improvements.
Improvements my appear within a few days or only be clear after a few months. There is no way to tell in advance how a child will react to the treatment.
Even if my child does not show any improvements, I am very excited that the study opened. I feel this study is a gate to something very big happening in Israel. It makes me happy that the healthcare system in Israel is growing in stem cell therapy.
Stem cell therapy has the potential to help syndromes, illnesses and conditions that were either untreatable or required much more invasive treatments with harsh side-effects and low success rates. Our blog mainly focus on the benefits stem cell and cord blood for autism and epilepsy, since we saw the incredible results with our own eyes. However, the list of conditions that can be treated overseas, in the private sector is incredible, and we would love to see our public healthcare system making this treatment routine.
We are hoping to create a clinic in Israel, where parents of special needs parents will receive guidance one understanding and raising special needs children. Our blog will probably undergo some changes soon. We will be taking a break from blogging to finalize the new design and launch our new plan.