NCT01451528

Allogeneic Umbilical Cord Blood Therapy for Chronic TBI

The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bundang CHA Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open label trial is conducted to investigate the efficacy and safety of umbilical cord blood therapy for chronic traumatic brain injury patients. The study hypothesis is that the participants will show significant improvement in cognition and function after Umbilical cord blood (UCB) transplantation.

Detailed description

Traumatic brain injury patients have been increasing due to various accidents. After acute therapeutic intervention, rehabilitation is the conventional main treatment with medication. However, in chronic stage, there seems to be some limitation in obtaining functional improvement in spite of comprehensive rehabilitation. Cell therapy like Umbilical cord blood (UCB) transplantation has showed promising results in many animal studies. The mechanism of such neurological improvement is not fully understood. Stem cells included in UCB are expected to secrete neurotrophic factors to enhance brain function. In addition, anti-inflammatory effects of UCB are suggested. Autologous UCB are not available in most of the cases in fact. The aim of this clinical trial is to determine the safety and efficacy of allogeneic UCB.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Umbilical Cord Blood	Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2011-10-13
• Last updated: 2014-04-03

Locations

1 site across 1 country: South Korea