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

Stem Cell Transplantation Clinical Trial

— ASPRA  

Official title:

Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism: An Open Label Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225651
• Other study ID #: VinmecRISCGT69
• Status: Completed
• Phase: Phase 2
• Start date: July 18, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2018
• Source: Vinmec Research Institute of Stem Cell and Gene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Autistic Disorder
• Stem Cell Transplantation

Intervention

Biological:
• Stem cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear cells

Behavioral:
• Psychological therapy and Rehabilitation
Psychological Therapy and Rehabilitation for autism children around 3 months

Locations

Country	Name	City	State
Vietnam	Vinmec Research Institute of Stem Cell and Gene Technology	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vinmec Research Institute of Stem Cell and Gene Technology

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the change in autism level by using tools	using total score of childhood autism rating scale, autism diagnostic observation schedule second edition, DENVER II, Indian Scale for assessment of Autism	6 months and 12 months after transplantation
Primary	Evaluate the safety of therapy by record number of adverse events		Through study completion, an average of 12 months