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Adipose Derived Stem Cell Therapy for Autism

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Instituto de Medicina Regenerativa, S.A. de C.V.
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT01502488
First received: December 27, 2011
Last updated: July 19, 2017
Last verified: July 2017
  Purpose

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.

Condition Intervention Phase
Autism Procedure: Fat Harvesting and Stem Cell Injection Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • Improvement in the Childhood Autism Rating Scale,CARS [ Time Frame: 3 months ]
  • Improvement in the Clinical Global Impression Scale, CGI [ Time Frame: 3 months ]
  • Improvement in the Childhood Autism Rating Scale,CARS [ Time Frame: 6 months ]
  • Improvement in the Clinical Global Impression Scale, CGI [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Improvement in the Aberrant Behavior Checklist, ABC [ Time Frame: 3 months ]
  • Improvement in the Aberrant Behavior Checklist, ABC [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: October 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Fat Harvesting and Stem Cell Injection
    Cells will be harvested through a local liposuction and injected via IV delivery
    Other Names:
    • Liposuction
    • Adipose Derived Stem Cell Injection
    • ADSC
    • Lipo
    • Fat Stem Cells
    • IV
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-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.
  Eligibility

Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502488

Locations
United States, Florida
Ageless Regenerative Institute LLC
Aventura, Florida, United States, 33180
Sponsors and Collaborators
Ageless Regenerative Institute
Instituto de Medicina Regenerativa, S.A. de C.V.
Investigators
Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute
  More Information

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT01502488     History of Changes
Other Study ID Numbers: ADI-AT-001
Study First Received: December 27, 2011
Last Updated: July 19, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ageless Regenerative Institute:
Autistic
ASC therapy
ADSC

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2017