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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03225651

Acronym

ASPRA

Enrollment

Registered

2017-07-21

Start date

2017-07-18

Completion date

2019-08-30

Last updated

2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stem Cell Transplantation

Keywords

Stem cell, Autism, Psychological, Rehabilitation

Brief 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

Detailed 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

Interventions

BIOLOGICALStem cell transplantation

Transplantation of Autologous Bone Marrow Mononuclear cells

BEHAVIORALPsychological therapy and Rehabilitation

Psychological Therapy and Rehabilitation for autism children around 3 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

Open Label

Eligibility

Sex/Gender

ALL

Age

3 Years to 7 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026