Autologous Bone Marrow Stem Cell Therapy for Autism

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2015
• Main ID: NCT02627131
• Date of registration: 07/12/2015
• Prospective Registration: No
• Primary sponsor: Vinmec International Hospital
• Public title: Autologous Bone Marrow Stem Cell Therapy for Autism
• Scientific title: Autologous Bone Marrow Stem Cell Therapy for Autism: An Open Label Uncontrolled Clinical Trial
• Date of first enrolment: April 2014
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02627131
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Vietnam

Contacts

• Name: Liem T Nguyen, MD., PhD.
• Affiliation: Vinmec International Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV
(DSM-IV) diagnostic criteria for autistic disorder

Exclusion Criteria:

- Epilepsy

- Hydrocephalus with ventricular drain

- Coagulation disorders

- Allergy to anesthetic agents

- Severe health conditions such as cancer, failure of heart, lung, liver or kidney

- Active infections

- Severe psychiatric disorders



Age minimum: 3 Years
Age maximum: 16 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Autistic Disorder

Intervention(s)

Biological: Autologous Bone Marrow Mononuclear Cells

Primary Outcome(s)

Number of adverse events [Time Frame: Through study completion, an average of 6 months]

Change in Total Score of Childhood Autism Rating Scale (CARS) [Time Frame: 3 months and 6 months after transplantation]

Secondary ID(s)

TBG 003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors