Status:
WITHDRAWN
Adipose Derived Stem Cell Therapy for Autism
Lead Sponsor:
Ageless Regenerative Institute
Collaborating Sponsors:
Instituto de Medicina Regenerativa
Conditions:
Autism
Eligibility:
All Genders
3-12 years
Phase:
PHASE1
PHASE2
Brief Summary
The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Autism.
Detailed Description
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-deriv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01502488
Start Date
October 1 2016
End Date
January 1 2018
Last Update
July 21 2017
Active Locations (1)
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1
Ageless Regenerative Institute LLC
Aventura, Florida, United States, 33180