Allogeneic Umbilical Cord Blood Therapy for Chronic TBI

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01451528
• Other study ID #: TBIUCB
• Secondary ID: 2011-141
• Status: Withdrawn
• Phase: N/A
• First received: October 11, 2011
• Last updated: April 2, 2014
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2014
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic Traumatic Brain Injury Patient (onset duration: over 6 months)

• Glasgow Outcome Scale: 2, 3, 4, 5

Exclusion Criteria:

• High risk of pneumonia or renal function deterioration after immunosuppressant

• Possibility of drug hypersensitivity which is related to this study remedy

• Intractable seizure disorder

• Poor cooperation of guardian,including inactive attitude for rehabilitation

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Biological:
• Allogeneic Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Short-term Memory Function		Baseline - 6 months	No
Secondary	Changes in Global Outcome		Baseline - 6 months	No
Secondary	Changes in Intelligence		Baseline - 6 months	No
Secondary	Changes in Frontal Lobe Function		Baseline - 6 months	No
Secondary	Changes in Traumatic Brain Injury-related Symptoms		Baseline - 6 months	No
Secondary	Changes in Attention		Baseline - 6 months	No
Secondary	Changes in Behavior		Baseline - 6 months	No
Secondary	Changes in Emotion and Personality		Baseline - 6 months	No
Secondary	Changes in Motor Function and Activities of Daily Living		Baseline - 6 months	No
Secondary	Changes in Brain Structure		Baseline - 6 months	No
Secondary	Changes in Brain Glucose Metabolism		Baseline - 2 weeks	No