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

V

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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