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Autologus cord blood in autism treatment- new clinical trial in Romania

Researchers at Bioforum Foundation have been studying whether intravenous infusions of cord blood stem cells can help young children with autism spectrum disorder (ASD). The leader of this research group is dr Felician Stăncioiu. Dr. Stăncioiu is the lead investigator of a registered clinical trial NCT04007224 named “CORDUS” that is using autologous umbilical cord blood to treat children that have Autism Spectrum Disorder (ASD). This therapy is being conducted at Medicover Hospital for children in Bucharest, with sponsorship from Bio-Forum Foundation.

Surprisingly, given Romania’s low birthrate, Romania is one of the most active markets in Europe for cord blood banking. There are ten different private cord blood banks participating in the market, and the two main birthing hospitals in Romania offer their own cord blood banking services. Romania does not have a public banking system to store cord blood donations. The percentage of new mothers that bank their baby’s cord blood is estimated to be 7% in Romania, second in Europe only to Portugal at 10%. By comparison, in many countries that are famous for their medical technology, such as the United States, the penetration of cord blood banking is less than 3% of births10. The presence of so many cord blood banks in Romania makes for fierce competition, but is beneficial for spreading awareness among parents about cord blood storage and therapies with cells from perinatal sources. Health care professionals in Romania play an important role in educating patients about the option to save stem cells now to protect the family's long-term well-being. The price range among the private cord blood banks in Romania is very wide, so that parents at different income levels can afford to participate, and instalment payment plans are offered.

Biogenis can offer cord blood storage either locally in their state-of-the-art laboratory in Bucharest, or at Famicord headquarters in Warsaw, Poland. The CEO of Biogenis, Bogdan Bulumac, MD MBA, says that “Biogenis offers DNA isolation and storage for the whole family, metabolic testing for the baby, extra mesenchymal cell isolation from cord tissue for multiple usage, Transplant Assistance offered by a specialized Patient Navigator, and free treatment for cerebral palsy with the Neuro Transplant package. In the near future, we plan to go beyond all this and make one step forward towards advanced genetic testing.”

Nevertheless, Biogenis feels that the most important advantage of being their client is having access to new and revolutionary therapies with stem cells, when the child or relatives need it. More than 80 Romanian clients have benefited from stem cells therapies before the end of 2022, out of which 19 used samples released from the Biogenis laboratory in Bucharest. “There is no greater satisfaction of our work than seeing the gratitude of parents who acknowledge the improvement in their children who suffer from autism, cerebral palsy or developmental delays”, admits Cristina Mihăilă, Sales Director of Biogenis. Another 5 samples are expected to be released from our bank in the next two weeks.

Medical Regulations and Autism Therapy in Romania

Romania follows the EU rules governing healthcare and medical research. There are different types of cellular therapy currently available in Romania, and all of them are administered in hospitals, none are given in doctor’s offices or clinics. Stem cell transplantation is regulated and closely supervised by the Romanian National Authority in Transplantation (ANT) and is only performed by the Fundeni Institute Hospital in Bucharest and the University Hospital in Targu Mures. At the Fundeni Institute in Bucharest, under Prof. Colita’s team, more than 1000 bone marrow and peripheral blood stem cell transplants have been performed for oncological and hematological pathologies since the year 2000. These treatments are also available in Targu Mures under Prof. Benedeck’s team. Advanced cell therapies for hematologic malignancies have also come to Romania. During the year 2022, the first three patients received CAR-T therapies at the Fundeni Institute. Investigational cell therapy is available in Romania either as part of a research clinical trial or under the framework of EU compassionate care regulations. The compassionate care criteria allow for the legal administration of stem cells when a patient suffers from a condition that is chronic, debilitating, or life-threatening. This last resort framework allows patients to receive a treatment which is not currently accepted as standard-of-care, after previous treatments have failed to cure or improve the patient’s condition, and if the doctor administering the investigational treatment considers that the risk/benefit ratio of the treatment is favorable. Compassionate care exemptions for stem cell therapy in Romania have been limited; “stem cell treatments were so far performed only sporadically - less than 100 patients since 2000”, according to Felician Stăncioiu, MD, co-author of this article and a medical researcher in Romania. He says that the compassionate care framework is being used at selected hospitals to treat patients with Mesenchymal Stromal Cells derived from the patient’s own fat tissue (autologous adipose MSC). This therapy is available at the Monza Hospital and Sanador Hospital, both of which are private hospitals. The Angiomedica Hospital use to have a research program giving adipose-derived MSC for several neurological pathologies, such as stroke or ALS, but this program is currently not active.

Dr. Stăncioiu is the lead investigator of a registered clinical trial NCT04007224 named “CORDUS” that is using autologous umbilical cord blood to treat children that have Autism Spectrum Disorder (ASD). This therapy is being conducted at Medicover Hospital for children in Bucharest, with sponsorship from Bio-Forum Foundation. The trial was originally launched in 2019 with the goal to test infusions of cord blood (the experimental arm of the controlled study) against a “non-invasive” therapy relying on intranasal oxytocin combined with dietary supplements ingested orally (the control arm of the study). The trial has a cross-over study design in which children that received one treatment at their first visit will receive the other treatment two months later. In this way, all children receive both therapies, and all children are followed until one year after the initial treatment. It must be cautioned that the results of this study will not be directly comparable to the well-known trials of cord blood for ASD at Duke University12, because the outcomes are measured on a different scoring system. This trial has been extended to a larger group of ASD patients ages 3 to 7 years old, due to good results so far. In the course of this study, Dr. Stăncioiu has discovered a new biomarker for ASD, and this finding will be published in the next months in the journal Experimental and Therapeutic Medicine. "Even though the Bucharest clinical study has so far treated a small number of ASD kids (around 40), it has also tested kids who were not enrolled, and has found out that blood levels of Neuron Specific Enolase (NSE) was elevated in most ASD kids. Only 1 in 20 ASD kids tested had a normal NSE value, so that NSE may be an important biomarker for ASD, and together with inflammation markers can better guide treatment strategies for ASD.” To conclude, Romania is emerging as a European destination that offers cutting edge banking and therapies with perinatal cells.