NCT01502488

Brief Summary

The intent of this clinical study is to answer the questions:

  1. 1.Is the proposed treatment safe
  2. 2.Is treatment effective in improving the disease pathology of patients with Autism.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
4.8 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

December 27, 2011

Last Update Submit

July 19, 2017

Conditions

Autism

Keywords

AutisticASC therapyADSC

Outcome Measures

Primary Outcomes (4)

  • Improvement in the Childhood Autism Rating Scale，CARS

    3 months

  • Improvement in the Clinical Global Impression Scale, CGI

    3 months

  • Improvement in the Childhood Autism Rating Scale，CARS

    6 months

  • Improvement in the Clinical Global Impression Scale, CGI

    6 months

Secondary Outcomes (2)

  • Improvement in the Aberrant Behavior Checklist, ABC

    3 months

  • Improvement in the Aberrant Behavior Checklist, ABC

    6 months

Interventions

Fat Harvesting and Stem Cell InjectionPROCEDURE

Cells will be harvested through a local liposuction and injected via IV delivery

Also known as: Liposuction, Adipose Derived Stem Cell Injection, ADSC, Lipo, Fat Stem Cells, IV

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ageless Regenerative Institute LLC

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

LipectomyHMGA2 Protein

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery ProceduresHMGA ProteinsDNA-Binding ProteinsProteinsAmino Acids, Peptides, and ProteinsHigh Mobility Group ProteinsChromosomal Proteins, Non-HistoneNuclear ProteinsNucleoproteins

Study Officials

  • Sharon McQuillan, MD

    Ageless Regenerative Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2011

First Posted

December 30, 2011

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(1)