Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

November 30, 2016

Study Completion Date

October 31, 2017

Conditions
AutismAutism Spectrum
Interventions
BIOLOGICAL

Autologous Intrathecal Hematopoietic Stem Cells

Patients will be stimulated with granulocyte colony-stimulating factor (G-CSF) for 3 consecutive days. Bone marrow will be harvested, processed to isolate CD34+ hematopoietic stem cells and reduce red blood cells. An inoculum of 5-10 mL will then be infused intrathecally into the cerebrospinal fluid.

OTHER

Observation with IDEA and CARS Scales

Participants will be observed for 6 months without active intervention. They will be evaluated using the Childhood Autism Rating Scale (CARS) and the IDEA scale at baseline, 30 days, and 180 days. After 6 months, participants may crossover to the experimental arm.

Trial Locations (1)

64460

Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez, Monterrey

All Listed Sponsors
lead

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

NCT01740869 - Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders | Biotech Hunter | Biotech Hunter