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Stem Cell Therapy

group 1 for Autism Spectrum Disorder

Phase 2
Recruiting
Led By Omer Bar-Yosef, MD.PHD
Research Sponsored by Sheba Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This study is a phase II, prospective, double blind, placebo-controlled study of the efficacy of autologous umbilical cord blood infusion. The study population will consist of 60 children ages 18 months to 12 years with ASD. The population will be randomly assigned to 2 groups, the study group be treated by cord blood in the beginning of the study and the control group by placebo product. The study will consist of 4 stages Stage 1: initial assessment by physiotherapist and occupational therapist / treatment by cord blood or placebo / blood work before and after treatment Stage 2: at stage 1 + 6 months assessment by physiotherapist and occupational therapist / cross-over treatment by cord blood or placebo / blood work before and after treatment Stage 4: at stage 1 + 12 months assessment by physiotherapist and occupational therapist The primary outcome is improvement of social communication skills six months after treatment at stage 1

Eligible Conditions
  • Autism Spectrum Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Functional assessment
Improvement of social communication skills

Trial Design

2Treatment groups
Experimental Treatment
Group I: group 2Experimental Treatment1 Intervention
The placebo product will consist of the standard ingredients of the acellular content of the UCB unit. It will consist of 20 ml Dextran (Plander 40.000 - 50g/500ml, solution for infusion) and 20 ml of human Albumin 5% (solution for infusion). The volume of placebo product will be 40 ml,
Group II: group 1Experimental Treatment1 Intervention
Autologous umbilical cord blood transfusion Single dose of an Autologous umbilical cord blood transfusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous umbilical cord blood
2019
Completed Phase 1
~40
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Sheba Medical CenterLead Sponsor
727 Previous Clinical Trials
2,840,608 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
390 Patients Enrolled for Autism Spectrum Disorder
Omer Bar-Yosef, MD.PHDPrincipal InvestigatorSheba Medical Center
1 Previous Clinical Trials
72 Total Patients Enrolled
~2 spots leftby Dec 2024