Peleg’s Story of Cell Therapy for Autism

Orly is a 41-year-old mother who lives with her husband Roy and her three children in kibbutz Givat Brenner, near Rehovot Israel. Her youngest child, Peleg, was born in Sept. 2018. Aside from a long labor (4 days), his birth was normal and for the first two years his development was normal. He passed all the milestones for motor skills on time. His social and communication skills started out normal. As a baby and toddler, he made eye contact and mimicked his mother’s face. He started babbling, then he started to speak.

As he approached age 2, Peleg began to withdraw. His eye contact and use of words decreased, he stopped playing with his older brother and sister. By then it was 2020 and everyone was locked down at home during the Coronavirus pandemic. People reassured his mother, “Oh it is just because he does not see other children that he does not speak.” But as this situation progressed, his mother observed that he seemed to be stuttering on consonants, trying to get words out, and he could not. He would become very angry and hit his parents instead of using words.

Peleg’s mother tried to intervene with speech therapy. Since she was at home in pandemic lockdown, she was already running a school at home for her children. She learned different methods of speech therapy and tried them all with Peleg, working on his speech every day. She tried to help Peleg develop his facial muscles for speech, she even took Peleg for hydrotherapy once the lockdown was lifted. There were small improvements with these interventions, but then Peleg would lose skills again. It took constant effort to make small progress and prevent him from falling back.

Meanwhile, as time passed, Peleg’s behavior was lagging behind milestones or deteriorating in many other ways. He did not learn to put his clothes on by himself, he did not learn to use the toilet. He did not know how to play with other children. He even had a hard time playing pretend games alone. He followed ritual behaviors, and he made repetitive movements. He was sleeping less and less at night. He became a very picky eater, and even though his mother was constantly chasing him with food he started losing weight.

Orly was convinced something was seriously wrong with her son, that he was disappearing before her eyes. But when she tried to look up his symptoms on Google, she found that any one symptom can have many possible explanations, some of them terrible. She did not see an explanation for the pattern. Finally, late one night she googled the English phrase, “child stopped talking,” and learned that this is called “regression,” and that regression is a symptom of Autism. She went to her husband and told him “I think Peleg has Autism. He meets 8 of the 10 criteria”.

Before Cell Therapy July 2022

Orly believes that Israel needs to do more to raise awareness of autism among parents and pediatricians. She says there is very little information about autism on the internet in Hebrew. She only found the information she needed because she is fluent in English. A proper diagnosis of Autism Spectrum Disorder (ASD) requires a full neurological – psychological evaluation that takes hours over multiple days. Orly tried to take Peleg for a neuro-psych through the public health service, but they told her to wait 8 months. Orly went to a private doctor instead and paid for the neuro-psych out of pocket. Peleg was diagnosed at age 2 years old as being on the autism spectrum. In Israel, a child diagnosed with ASD is considered “disabled.” Once Peleg had a positive diagnosis, Orly was reimbursed for his neuro-psych testing, and she began to receive a monthly disability stipend for Peleg.

A lot of parents in support groups believe that vaccines cause autism. But Peleg had not been vaccinated on time, because his mother was stuck in the house with three children during a pandemic. Peleg’s autism could not be blamed on vaccines. Orly believes the language regression happened around age 2 because that is when his autism predisposition activated. Orly has obtained genetic testing for her entire extended family, and she now knows that there is a gene associated with autism which runs in her family.

Having the autism diagnosis was just the beginning. Orly was still seeking an intervention that could help Peleg. She was aware of cell therapy for autism and started talking to other parents who had tried it. As he approached age 4, Peleg was down to sleeping three hours per night. He had lost a few kilos of weight. Orly and her husband Roy decided to try cell therapy. “There is no harm in that therapy – what could I lose?”

In August 2022, Orly and Roy took Peleg to Swiss Medica stem cells clinic in Belgrade, Serbia. Since Orly had not saved cord blood from her children’s births, she needed to find a clinic that provided mesenchymal stromal cells (MSC) from a donor. The decision to try Swiss Medica was partly because several Israeli families had gone there and were able to give feedback about their experiences. Another important factor is that Serbia is only 3.5 hours by plane from Israel. Orly felt that any stem cell clinic in Latin America was out of the question, because Peleg could not stay in his seat for long and would try to exit the plane in mid-air.

The family spent a week in Belgrade and Peleg received cell therapy over the course of five days. According to the certificates from the Swiss Medica clinic, on day one Peleg received an intravenous infusion that contained 79 million cells of MSC from umbilical cord tissue (UC-MSC). On day two he received an infusion of 80 million cells of MSC from placenta (PL-MSC). Days three and four were intramuscular injections into the buttocks of 32 million PL-MSC and 34 million UC-MSC, respectively. Finally, on each day Peleg received two intranasal doses of exosomes (EV) from placenta MSC, which the laboratory certificate describes as holding a minimum of 400 million EV with a maximum of size of 200 nm.

After Cell Therapy August 2022 + 2 Weeks

It is difficult to compare Peleg’s therapy at Swiss Medica to the treatments in official clinical trials. The registered clinical trials of cell therapy for autism all deliver cells either by infusion into a vein or by intrathecal injection into the spinal cord. There are no clinical trials that employ intramuscular injections of cells. There has never been any clinical trial of exosomes for autism. However, we can compare the intravenous cell doses. Peleg received two intravenous infusions at a dose of 4.75 million MSC per kg (his weight at the time was 16.7 kg). By comparison, the largest trial of UC-MSC for autism in children at Duke used a dose of 6 million MSC/kg, but only one dose. Hence the net dose of IV MSC at Swiss Medica was about 50% higher than the Duke dose, if the cell viability was comparable across the two centers.

Peleg started to transform rapidly after the cell therapy. The night after his first infusion, Peleg slept through the entire night. Orly had been taking lots of photos and videos of Peleg to document his behavior.  Two days after his first infusion, he said his first 3-word sentence: “Mommy, I’m hungry”. You can imagine his mother’s shock and delight. During the week that the family was in Serbia, he played hide and seek with his sister for the first time. Since then, Peleg has made rapid progress in many behaviors, summarized in the table below. The embedded videos of Peleg from the month before and after cell therapy show that the improvements in his language skills were too rapid to be explained away by standard interventions. His professional speech therapist says that in the six months after his cell therapy, he made four years of progress.

This is just one case report and does not guarantee results for other children, but Peleg’s family is very glad that they took the chance on cell therapy for this autism while he was still young.

Appendix on Cell Preparation

Swiss Medica is headquartered in Switzerland and operates clinics in Switzerland, Serbia, and Slovenia. Swiss Medica of Serbia has a relationship with Burnasyan FMBC of FMBA, a fully equipped state-of-the-art laboratory which is capable of preparing and characterizing stem cells for medical therapy. Parent’s Guide to Cord Blood submitted interview questions about the cell preparation procedures and obtained the following answers.

Informed consent of the mothers is obtained prior to delivery. The donor must meet certain criteria, such as maternal age up to 35 years old, unhampered medical history, fetus at least 38 weeks gestation. Birth tissues are only collected from C-section births, to minimize contamination.

MSC Isolation: Mesenchymal Stromal Cells (MSC) are isolated from both the umbilical cord tissue and from the placenta. The umbilical cord is dissected to separate the Wharton’s Jelly from the blood vessels and the outer sheath. The MSC are isolated form the pure Wharton’s Jelly by the explants method. The placenta is dissected to separate decidua basalis, chorionic plate, chorionic vili, and amniotic membrane. The placenta MSC that are used for therapy are isolated by enzymatic cleavage from tissue that comes from the chorionic plate and chorionic vili.

MSC culture: The culture medium for the MSC expansion phase is MesenPRO or Dulbecco's Modified Eagle Medium F12 (DMEM F12), both from Thermo Fisher Scientific, with antibiotic/antimycotic, as well as the growth supplements MesenPRO and/or human blood serum.

Passages: The MSC are expanded for two passages before being harvested and frozen in cryogenic storage.

MSC clinical delivery: At the time of treatment, the MSC are thawed and reconstituted in a brief culture to recover from cryopreservation. They are subjected to a final inspection. The parents are given a certificate describing the type of cells, the cell counts, cell viability, results of sterility tests, and the results of cell characterization according to immunophenotype surface markers. The certificate will say that cells were cultured to passage three, because this is the net number of passages combining cultures both pre-storage and post-storage.

Exosomes. The exosomes, also known as extracellular vesicles (EV), are derived from the medium in which the placenta MSC were cultured. They are isolated by ultrafiltration and diafiltration (UF/DF). Sample lots were characterized by flow cytometry of immunophenotype (markers CD63, CD9, CD81). The EV were subjected to in-vitro testing to confirm that their functional behavior is consistent with the expected influence of EV on T-reg cell proliferation, macrophage polarization, and fibroblast monolayer repair. The goal of the strict quality controls is to achieve an EV product that is stable enough so that parents can take home a vial of the product and continue giving intranasal doses for several weeks at home.