NCT04243408

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 2 Months – 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
OTHER	Autologous umbilical cord blood transfusion	single dose of an autologous umbilical cord blood transfusion
OTHER	placebo	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

Timeline

• Start date: 2020-07-08
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-01-28
• Last updated: 2021-01-20

Locations

1 site across 1 country: Israel