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.

Study Overview

• Status: Withdrawn
• Conditions: Autism
• Intervention / Treatment: Procedure: Fat Harvesting and Stem Cell Injection

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Aventura, Florida, United States, 33180
      • Ageless Regenerative Institute LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Improvement in the Aberrant Behavior Checklist, ABC	3 months
Improvement in the Aberrant Behavior Checklist, ABC	6 months

Collaborators and Investigators

• Sponsor: Ageless Regenerative Institute
• Collaborators: Instituto de Medicina Regenerativa

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: December 27, 2011
• First Submitted That Met QC Criteria: December 29, 2011
• First Posted (Estimate): December 30, 2011

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Autistic; ADSC; ASC therapy
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: ADI-AT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided