蘇格蘭的醫生與英國生技業者再生神經元公司(ReNeuron)合作,展開開創性臨床試驗,把幹細胞注射入病患腦部,測試以此種全球首創方法治療中風殘障者的安全性。
數週前美國Geron公司率先利用胚胎幹細胞治療脊髓損傷的病人,開啟幹細胞對腦神經系統的臨床治療.ReNeuron的臨床試驗是利用12周大的胎兒神經幹細胞,藉由基因修飾來治療中風病患.這是全球首例,專家指稱,有理由對它抱持「審慎樂觀」。
主要研究人員格拉斯哥大學神經科學暨心理學研究所專家穆爾說,首位病人是60多歲男性,他的手術治療進展順利且已出院。格拉斯哥大學發言人表示,「他將會接受密切監視長達2年,參與這項臨床實驗的其他全部病患也一樣。」
這項治療程序涉及把ReNeuron的神經幹細胞注射入病患腦部,寄望它們將會修補因中風受損區域,進而改善病患的生理和心理功能。初期試驗的目的主要是測試這項實驗性治療方式對中風病患是否安全。
穆爾說,「我們希望未來它能帶動更大規模研究,判定幹細胞對中風導致殘障病患的效應。」
共有12名病患將在發生缺血性中風後6到24個月內,接受ReNeuron的ReN001細胞治療,並接受長達2年的進展追蹤。
詳細影片請見 http://www.bbc.co.uk/news/health-11763681
電子顯微鏡下的病人逐漸增加的高劑量幹細胞之立體圖像
Stem cells used in stroke trial
The elderly man is the first person in the world to receive this treatment - the start of a regulated trial at Southern General Hospital.
He was given very low doses over the weekend and has since been discharged - and his doctors say he is doing well.
Critics object as brain cells from foetuses were used to create the cells.
The patient received a very low dose of stem cells in an initial trial to assess the safety of the procedure.
Over the next year, up to 12 more patients will be given progressively higher doses - again primarily to assess safety - but doctors will be looking closely to see if the stem cells have begun to repair their brains and if their condition has improved.
Early stages
It also points out that foetuses were used in the very early stages of the research and are now no longer used.
Professor Keith Muir, a neuroscientist at Glasgow University and a consultant neurologist at Southern General Hospital, said if the trials went well it would lead to more detailed research.
"We hope that in the future it will lead to larger studies to determine the effectiveness of stem cells on the disabilities that result from strokes," he said.
The first group of patients to receive the treatment will be men over 60 who have shown little or no improvement in their condition over a number of years.
It is an ideal group to assess the safety of the procedure - doctors will be keen to know first of all that the treatment makes them no worse.
But having such a precisely defined group will enable doctors and scientists to compare like with like if they notice any improvement - even in these early stages.
If these trials show promise, doctors plan larger trials on a more varied group of patients. The earliest this could begin is in two years' time.
There will be more focus on assessing the effectiveness, if any, of the stem cell treatment and on which groups it works best.
Patients will be monitored for two years, followed by longer term procedures after that.
The announcement from the Glasgow team comes a few weeks after the US firm Geron said it had begun its clinical trials on a patient to develop a treatment for paralysis.
The development of stem cell treatments is still at a research stage and it is likely to be many years before becoming widely available.
But new potential treatments are now beginning to make their way from the scientist's laboratory into the doctor's clinic.
Strokes kill around 67,000 people in the UK every year, according to the Stroke Association.
The charity says it is the third most common cause of death in England and Wales after heart disease and cancer.
The disabilities suffered by patients also have a greater impact than any other chronic disease, it adds.
The trial is being carried out with ReNeuron Group plc which was given approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in January last year.
The company's Chief Executive Officer Michael Hunt said: "The initiation of the clinical trial is a major and hard-won milestone in the development of therapies to address the severely disabling effects of stroke."
