Adipose Derived Stem Cell Therapy for Autism

NCT ID: NCT01502488

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-01-31

Brief 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.

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.

Conditions

Autism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Fat Harvesting and Stem Cell Injection

Cells will be harvested through a local liposuction and injected via IV delivery

Intervention Type: PROCEDURE

Other Intervention Names

Liposuction; Adipose Derived Stem Cell Injection; ADSC; Lipo; Fat Stem Cells; IV

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Medicina Regenerativa

INDUSTRY

Sponsor Role: collaborator

Ageless Regenerative Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon McQuillan, MD

Role: PRINCIPAL_INVESTIGATOR

Ageless Regenerative Institute

Locations

Ageless Regenerative Institute LLC

Aventura, Florida, United States

Countries

United States

Other Identifiers

ADI-AT-001

Identifier Type: -

Identifier Source: org_study_id