Adipose Derived Stem Cell Therapy for Autism

Autism Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01502488
• Other study ID #: ADI-AT-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: December 27, 2011
• Last updated: July 19, 2017
• Start date: October 2016
• Est. completion date: January 2018

Study information

• Verified date: July 2017
• Source: Ageless Regenerative Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Procedure:
• Fat Harvesting and Stem Cell Injection
Cells will be harvested through a local liposuction and injected via IV delivery

Locations

Country	Name	City	State
United States	Ageless Regenerative Institute LLC	Aventura	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Ageless Regenerative Institute	Instituto de Medicina Regenerativa, S.A. de C.V.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in the Childhood Autism Rating Scale,CARS		3 months
Primary	Improvement in the Clinical Global Impression Scale, CGI		3 months
Primary	Improvement in the Childhood Autism Rating Scale,CARS		6 months
Primary	Improvement in the Clinical Global Impression Scale, CGI		6 months
Secondary	Improvement in the Aberrant Behavior Checklist, ABC		3 months
Secondary	Improvement in the Aberrant Behavior Checklist, ABC		6 months