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Adipose Derived Stem Cell Therapy for Autism

This study is not yet open for participant recruitment. (see Contacts and Locations)
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: March 19, 2014
Last verified: December 2011

December 27, 2011
March 19, 2014
October 2014
November 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01502488 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Adipose Derived Stem Cell Therapy for Autism
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

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autism
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
January 2017
November 2016   (final data collection date for primary outcome measure)

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.
Both
3 Years to 12 Years
No
Contact: Kristin Comella 813 390 9874 comella_5@yahoo.com
Mexico
 
NCT01502488
ADI-AT-001
No
Ageless Regenerative Institute
Ageless Regenerative Institute
Instituto de Medicina Regenerativa, S.A. de C.V.
Principal Investigator: Arnoldo Sierra, MD Instituto de Medicina Regenerativa
Ageless Regenerative Institute
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP