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Adipose Derived Stem Cell Therapy for Autism

This study is currently recruiting participants.
Verified December 2011 by Ageless Regenerative Institute
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: December 29, 2011
Last verified: December 2011
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • Improvement in the Childhood Autism Rating Scale，CARS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in the Clinical Global Impression Scale, CGI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in the Childhood Autism Rating Scale，CARS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement in the Clinical Global Impression Scale, CGI [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in the Aberrant Behavior Checklist, ABC [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Improvement in the Aberrant Behavior Checklist, ABC [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502488

Contacts
Contact: Janny Garcia, Biomedical Engineer 855-274-2355 jgarcia@agelessregen.com
Contact: Kristin Comella, Chemical Engineer kcomella@agelessregen.com

Locations
Mexico
Instituto de Medicina Regenerativa Recruiting
Tijuana, Baja California, Mexico, 22010
Contact: Jesus A Perez            
Principal Investigator: ARNOLDO SIERRA, MD            
Sponsors and Collaborators
Ageless Regenerative Institute
Instituto de Medicina Regenerativa, S.A. de C.V.
Investigators
Principal Investigator: Arnoldo Sierra, MD Instituto de Medicina Regenerativa
  More Information

No publications provided

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: December 29, 2011
Health Authority: MEXICO: COFEPRIS- Comisión Federal para la Protección contra Riesgos Sanitarios

Keywords provided by Ageless Regenerative Institute:
Autistic
ASC therapy
ADSC

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013