Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism

Autism Clinical Trial

Official title:

Open, Prospective Trial of Treatment of Autism Spectrum Disorders (ASD) Using Intravenous Infusion of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192749
• Other study ID #: TBS-UCMSC-ASD001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 12, 2014
• Last updated: October 12, 2017
• Start date: July 2014
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Translational Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Allogeneic (not from the subject) human umbilical cord tissue-derived stem cells administered intravenously (IV) in a series of 4 infusions every 3 months over the course of one year is safe and will induce a therapeutic effect in autism patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• Male or Female

• Ages 6 to 16

• Diagnostic and Statistical Manual of Mental Disorders (DSM IV) diagnosis of autism confirmed by Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised (ADI-R)

• No anticipated changes in treatment for the study duration (e.g., diet, nutrients)

• No additional biomedical treatments started 6 weeks prior to enrollment

• No changes in dietary management for 3 months prior to enrollment

• Ambulatory or require minimum support walking, per parent

• Able to sit still for 5 minutes or longer with a preferred toy item, per parent

• Adequate vision and hearing for the purposes of test administration, per parent

• Adequate arm-hand-finger coordination (i.e., able to point) for learning and cognitive tasks used in outcome measurement, per parent

• Stable and controlled mental disorder

• Under the care of a caregiver willing to participate by attending regularly scheduled appointments and completing the necessary measures

• Normal heavy metals test for lead and mercury levels performed within 30 days of first stem cell infusion

• Must provide name and specialty of specialist who has made Autism Spectrum Disorder (ASD) diagnosis

• Adequate financial means to cover $7,200 (US Dollars) plus travel expenses

Exclusion Criteria:

• Significant prematurity at birth (less than 32 weeks gestation); or birth weight significantly below normal for gestational age (SGA - small for gestational age)

• mental retardation

• seizure disorder

• auto-immune conditions

• history of head trauma and other neurological or medical conditions

• Abnormal heavy metals test for lead and mercury performed within 30 days of first stem cell infusion

• Prior stem cell therapy of any kind

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Biological:
• Umbilical cord mesenchymal stem cells

Locations

Country	Name	City	State
Panama	Stem Cell Institute	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
Translational Biosciences

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		89 weeks
Secondary	Number of participants with a change in disability as measured by the Autism Treatment Evaluation Checklist (ATEC)		13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks
Secondary	Number of participants with a change in disability as measured by the Childhood Autism Rating Scale (CARS)		13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks
Secondary	Change from baseline macrophage-derived chemokine (MDC)		13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks
Secondary	Change from baseline thymus and activation-regulated chemokine (TARC)		13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks