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Treatment of Children With Cerebral Palsy With Autologous Umbilical Cord Blood, a Pilot Study

Cerebral Palsy Clinical Trial

Official title:
Treatment of Children With Cerebral Palsy With Autologous Umbilical Cord Blood, a Pilot Study

Clinical Trial 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 72 children ages 2 months to 12 years with cerebral palsy. The population will be randomly assigned to 2 groups, 36 children in each group. The study group be treated by cord blood in the beginning of the study and the control group by placebo product. The study population will be stratified to reduce variance 3 groups by age: 2-12 months / 1-6 years / 6-12 years 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 + 3 months assessment by physiotherapist and occupational therapist Stage 3: 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 motor skills six months after treatment at stage 3

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04243408
Study type Interventional
Source Sheba Medical Center
Contact Omer Bar-Yosef, MD.PHD
Phone 972-35302895
Email Omer.BarYosef@sheba.health.gov.il
Status Recruiting
Phase Phase 2
Start date July 8, 2020
Completion date December 2024
View Details
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