Back to resultsAdipose Derived Stem Cell Therapy for Autism
Primary Purpose
Autism
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fat Harvesting and Stem Cell Injection
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autistic, ASC therapy, ADSC
Eligibility 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.
Sites / Locations
- Ageless Regenerative Institute LLC
Outcomes
Primary Outcome Measures
Improvement in the Childhood Autism Rating Scale，CARS
Improvement in the Clinical Global Impression Scale, CGI
Improvement in the Childhood Autism Rating Scale，CARS
Improvement in the Clinical Global Impression Scale, CGI
Secondary Outcome Measures
Improvement in the Aberrant Behavior Checklist, ABC
Improvement in the Aberrant Behavior Checklist, ABC
Full Information
NCT ID
NCT01502488
First Posted
December 27, 2011
Last Updated
July 19, 2017
Sponsor
Ageless Regenerative Institute
Collaborators
Instituto de Medicina Regenerativa
1. Study Identification
Unique Protocol Identification Number
NCT01502488
Brief Title
Adipose Derived Stem Cell Therapy for Autism
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Study Start Date
October 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ageless Regenerative Institute
Collaborators
Instituto de Medicina Regenerativa
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autistic, ASC therapy, ADSC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Fat Harvesting and Stem Cell Injection
Other Intervention Name(s)
Liposuction, Adipose Derived Stem Cell Injection, ADSC, Lipo, Fat Stem Cells, IV
Intervention Description
Cells will be harvested through a local liposuction and injected via IV delivery
Primary Outcome Measure Information:
Title
Improvement in the Childhood Autism Rating Scale，CARS
Time Frame
3 months
Title
Improvement in the Clinical Global Impression Scale, CGI
Time Frame
3 months
Title
Improvement in the Childhood Autism Rating Scale，CARS
Time Frame
6 months
Title
Improvement in the Clinical Global Impression Scale, CGI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in the Aberrant Behavior Checklist, ABC
Time Frame
3 months
Title
Improvement in the Aberrant Behavior Checklist, ABC
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon McQuillan, MD
Organizational Affiliation
Ageless Regenerative Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ageless Regenerative Institute LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Adipose Derived Stem Cell Therapy for Autism
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