| BackgroundAutism is a behaviorally defined disorder associated with characteristic impairments in social interactions and communication,as well as restricted and repetitive behaviors and interest.The incidence of autism is about 0.6%-1%. There was obvious difference between boys and girls and the ratios were (4~5):1,but have no apparent cultural racial differences. At present,behavioral intervention,special education training and family treatment complementary with drug therapy were the main clinical treatment method of autistic patients. However,the result of those normal therapy was not good. The basic characteristics of stem cells was self-renewal,proliferation in vitro and the multiple differentiative potentials. It was proved that the stem cells could not only differentiate into several types of functioning mature cell but also treat for various organ damage. The aim of this study is to treat Low Functioning Autism with Human embryonic-derived Neural Precursor Cells(hNPCs) and autologous Bone Mesenchymal Stem Cells(BMSCs) , and to evaluate clinical safety and effectiveness by means of Autism Behavior Checklist(ABC),Childhood Autism Rating Scale(CARS) and revision of Chinese version of Psycho-ducational Profile(C-PEP) before and after treatment,and observe its adverse reactions.Object and Methods1. Object of studythis study of 18 Low Functioning Autism inpatients in November 2006 to September 2010 divided into Two groups. They treated with hNPCs and BMSCs respectively. hNPCs groups included 9 patients(1 women,8 men),whose mean age was 6.04±1.72 years and age range from 3.4 to 9.2. BMSCs groups included 9 male patients,whose mean age was 6.77±1.00 years and age range from 4.9 to 8.5. The standards of collection is that the age range from 3 to 12 and gender is not limited. And the diagnostic criteria for autism come from diagnostic and statistical manual of mental disorders-Ⅳand the psychiatrist diagnose clearly. And the intelligence quotient is smaller than 70.And there is no more effect on training half a year. And those patients must have legal guardian,who signed the cell transplantation therapy informed agreement and be under the consent and supervision of legal guardian.2. MethodshNPCs groups:Intracerebroventricular injection hNPCs by the skull drilling for one time.BMSCs groups:Subarachnoid and lumbar puncture injection BMSCs by the skull drilling once a week by 3 times.The number of stem cells every time was 2×10~6/Kg.3. Evaluation measurement and criterionThird-party physicians who has appraisal qualification evaluated those patients by means of ABC,CARS and C-PEP before cells treatment,1 months after cells treatment,3 months after cells treatment and 6 months after cells treatment,respectively. Meanwhile,the change between befor and after treatment observed and compared the two groups by statistical analysis.Results1. This study is a non-random,open,contrast clinical research.Research time:From November 2006 to September 2010.There was no one case dropped off in the process of research.The observation period is 6 months.In those two groups,which have the balanced data information at age,sex,history of encircles produces,family heredity history and IQ test(P>0.05),been provided with comparability.2. Safety Evaluation:The adverse event of the stem cells therapy in the treatment group is fever. When the stem cells therapeutic process terminated,this symptoms quickly disappeared. During the process of research,there are no reported severe adverse events.3. Effectiveness Evaluation:(1) From the statistical results,both of two treatment groups are affective,the different changing time of its curative effect among two groups has focused on after 3 months of the stem cells treatment. In which the hNPCs treatment Group has got the better effect than the BMSCs treatment Group. (2) Having compared those two treatment groups,the ABC grade has improved in these aspects:the ability of communication and speech ability. (3) Having compared those two treatment groups,the C-PEP grade has improved in these aspects:specific action.CONCLUSIONS1. Clinical practice of hNPCs and BMSCs for treating Low Functioning Autism is safe and feasible.2. Research shows that stem cells treatment has significant effects.3. Effectiveness comparison:Applying hNPCs therapy,this is better to using BMSCs therapy.
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