Attached is part of a PR Web Press Release for a clinical trial application being submitted to Greek authorities by AdiStem Tehcnology. It indicates that a group of doctors in Greece are preparing a protocol for submission to the Greek Ministry of Health for an official clinical trial of stem cell treatment on children with autism spectrum disorders:
Thestem cell technologydeveloped by AdiStem for the past 5 years has been used and trialed by doctors around the world for the treatment of type II diabetes and its complications, osteoarthritis, and cosmetic medicine. Physicians in Greece approached the company recently with the intent to treat Yannis, the son of Dr. Solomos, a cardiologist. Yannis, a 9 year old boy, had been diagnosed with autism but not responded to standard treatments.
An experienced doctor, the father, Dr Solomos, carefully reviewed the case studies of otherchildren with Autism who had received the AdiStem stem cell treatmentin Europe and Asia, and was convinced of its safety and potential for improving the condition of his son. With the help of experienced pediatric surgeons Yannis underwent an hour long mini-liposuction procedure at Kratiko Nikaias Hospital in Athens in which 200cc of abdominal fat was harvested. The fat was dissolved, the stem cells isolated and then activated, and over 100 million cells were returned to Yannis through a standard intravenous drip. Yannis was discharged on the same day.
Just one month later, his father was astonished to hear Yannis talking to him on the phone for the first time. Dr. Solomos explained: "my boy has simply not been able to speak to me on the phone before". Asked if he’d noticed any other changes, he replied: "His school tells me his attention has improved. We experience him nearer to us and he feels us. I see a change in his ability to connect with other children. He plays with them now, which he used to avoid. He has also become more interested in letters and numbers". (This interview with Dr.Solomos was recorded on video and can be viewed at"www.adistem.com/application/autism.htm").
Present during the treatment, Dr. Koliakos, Associate Professor at Aristotle University and President of Hellenic Research Foundation Stem Cell Bank pointed out: "One month after the therapy Yannis has shown remarkable progress according to his father's observations. The child will be reevaluated by pediatric psychiatrists 3 months after the therapy to measure the extent of progress in his condition and to decide if the remainder of his stem cells, presently stored in liquid nitrogen, should be administered".
Dr.Kolaikos continued: "We're convinced about the safety ofintravenous adipose stem cell therapy– if supported by accredited facilities – and our team has now applied for a large formal clinical trial on autism using AdiStem's stem cell protocol here in Greece".
Terry Grossman, M.D., stem cell researcher from Golden, Colorado said, "I was present to observe 9 year old Yannis undergo the stem cell procedure at the Kratiko Nikaias Hospital in Athens. Further studies are needed, but it is possible that stem cell therapy will soon be available asa powerful new tool to help children with autistic spectrum disorders."
There is much controversy surrounding most aspects of autism spectrum disorders including issues concerning treatment and research involving children. In this case the PR Web press release states that a trial was run with a child whose father, an experienced medical doctor, consented to his participation after reviewing case studies involving other children with autism who had received the treatment. The father, a medical doctor, also provide his observations which indicated substantial improvement in his son's condition. The procedure was performed by experienced pediatric surgeons and is vouched for by a Greek professor and researcher as being safe when administered at a proper facility. In addition to the father's observations the child will be seen at follow ups by pediatric psychiatrists for further measurement of his progress and for a determination of whether to continue with the treatment.
The procedure itself was observed by an American stem cell researcher/doctor who says further study is needed but that but it is possible that stem cell therapy will soon be available asa powerful new tool to help children with autistic spectrum disorders. The research team involved has applied for a large formal clinical trial on autism using AdiStem's stem cell protocol.
It will be interesting to see what comes of the Adistem application and formal clinical trial results. This father of a severely autistic 14 year old boy has insisted that my son receive only evidence based interventions and I will not depart from that principle. But I do not close my mind to new interventions either if they are subsequently supported by a strong evidence base. If responsible studies conducted safely, produce credible results and provide reliable evidence of new interventions that could help my son then I would want, in consultation with trusted professional advisers, to consider new interventions for his benefit.
It remains to be seen whether the AdiStem trials will provide such evidence but in the meantime this father of a severely autistic son will keep an open mind on the subject.