NCT01486732

FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy

FLT(3'-Deoxy-3'-[F-18]Fluorothymidine)-PET Activity Change After Allogeneic Umbilical Cord Blood Cell Therapy in Cerebral Palsy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bundang CHA Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 20 Years
• Healthy volunteers: Not accepted

Summary

This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.

Detailed description

FLT(3'-Deoxy-3'-\[F-18\]Fluorothymidine) has been developed as a cell-proliferation tracer. In animal study, FLT-PET was used as a tool that enables imaging and measuring of proliferation in the brain, thus it detects activity of endogenous neural stem cells noninvasively. This study aims to assess cell proliferation activity changes in the brain after Umbilical Cord Blood (UCB)Therapy for Cerebral Palsy patients using FLT-PET.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
BIOLOGICAL	Umbilical Cord Blood Infusion	The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
OTHER	Active Rehabilitation	All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 2.5 months.
OTHER	Placebo Umbilical Cord Blood	Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed : 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-04-01
• Completion: 2014-07-01
• First posted: 2011-12-06
• Last updated: 2013-11-19

Locations

1 site across 1 country: South Korea