- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01502488
Adipose Derived Stem Cell Therapy for Autism
July 19, 2017 updated by: Ageless Regenerative Institute
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:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Autism.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Aventura, Florida, United States, 33180
- Ageless Regenerative Institute LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 10 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
Time Frame: 3 months
|
3 months
|
Improvement in the Clinical Global Impression Scale, CGI
Time Frame: 3 months
|
3 months
|
Improvement in the Childhood Autism Rating Scale,CARS
Time Frame: 6 months
|
6 months
|
Improvement in the Clinical Global Impression Scale, CGI
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in the Aberrant Behavior Checklist, ABC
Time Frame: 3 months
|
3 months
|
Improvement in the Aberrant Behavior Checklist, ABC
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADI-AT-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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