Adipose Derived Stem Cell Therapy for Autism

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Autism

In brief

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.

Key facts

Study ID

NCT01502488

Run by

Ageless Regenerative Institute

People needed

0

Starts

2016-10-01

Expected to finish

2018-01-01

Last updated by the study team

2017-07-21

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ageless Regenerative Institute LLC — Aventura, Florida, United States

Full record on ClinicalTrials.gov

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