Adipose Derived Stem Cell Therapy for Autism | NCT01502488

Studies
Adipose Derived Stem Cell Therapy for Autism

NCT01502488

Sponsor

Ageless Regenerative Institute

Status

Withdrawn

Last Update Posted

Jul 21, 2017Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Autism

Interventions

Fat Harvesting and Stem Cell Injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Nov 2017Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Dec 27, 2011

First Submission Date that Met QC Criteria

Dec 29, 2011

First Posted Date

Dec 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2017

Last Update Posted Date

Jul 21, 2017Actual

Name	Class
Instituto de Medicina Regenerativa	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Fat Harvesting and Stem Cell Injection	Procedure	Cells will be harvested through a local liposuction and injected via IV delivery		Liposuction Adipose Derived Stem Cell Injection ADSC Lipo Fat Stem Cells IV

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000067877	Autism Spectrum Disorder
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D015187	Lipectomy
D025743	HMGA2 Protein

ID	Term
D003357	Cosmetic Techniques
D013812	Therapeutics
D050110	Bariatric Surgery
D049088	Bariatrics