Adipose Derived Stem Cell Therapy for Autism

Study Overview
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Brief Summary
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The intent of this clinical study is to answer the questions: Is the proposed treatment safe Is treatment effective in improving the disease pathology of patients with Autism.

Detailed Description
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This will be an open-label, non-randomized multi-center patient sponsored study of ASC implantation after liposuction using an IV delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered intravenously.

Official Title
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An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Autism

Conditions
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Autism

Intervention / Treatment
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* Procedure: Fat Harvesting and Stem Cell Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between the ages of 3 and 12 years. DSM-IV diagnosis of Autistic Disorder. Total score of CARS ≥ 30. Parents or legal guardian willing to sign the ICF. Exclusion Criteria: History of prior or current DSM-IV psychotic disorder (e.g., schizophrenia, bipolar disorder, other psychosis), Pervasive Developmental Disorder not otherwise specified (PDD NOS), Asperger's, or Rett's. History of Epileptic seizure activity in the past 6 months. Autism caused by seizure disorders (active), cerebrovascular disease or brain trauma. The global autism ratings are assessed as being absent, minimal or mild. Existing moderate or severe extrapyramidal symptoms (EPS) or history of tardive dyskinesia. Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have expert consultation to determine eligibility based on the patient's infectious status Enrollment in other trials in the last 3 months without agreement to discontinue them. Life expectancy < 6 months due to concomitant illnesses. Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results Patients on chronic immunosuppressive transplant therapy Active clinical infection within one week of enrollment. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. History of cancer Parental unwillingness and/or not able to give written informed consent.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Fat Harvesting and Stem Cell Injection|Cells will be harvested through a local liposuction and injected via IV delivery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the Childhood Autism Rating Scale，CARS |  | 3 months | 
| Improvement in the Clinical Global Impression Scale, CGI |  | 3 months | 
| Improvement in the Childhood Autism Rating Scale，CARS |  | 6 months | 
| Improvement in the Clinical Global Impression Scale, CGI |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the Aberrant Behavior Checklist, ABC |  | 3 months | 
| Improvement in the Aberrant Behavior Checklist, ABC |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autistic, ASC therapy, ADSC