Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism (ASPRA)

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Completed; Phase 2

Conditions: Stem Cell Transplantation

Treatments: Behavioral: Psychological therapy and Rehabilitation; Biological: Stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03225651

VinmecRISCGT69

Details and patient eligibility

About

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism children

Full description

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation in the management of autism of 60 patients at Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam from January 2017 to December 2018

Enrollment: 30 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-V 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
• Rett syndrome
• Fragile X syndrome

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Stem cell transplantation

Experimental group

Description:

Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward

Treatment:

Biological: Stem cell transplantation

Behavioral: Psychological therapy and Rehabilitation

Psychological therapy and rehabilitation

Experimental group

Description:

Psychological therapy Rehabilitation in 3 months

Treatment:

Biological: Stem cell transplantation

Behavioral: Psychological therapy and Rehabilitation