Clinical trial NCT01451528: Allogeneic Umbilical Cord Blood Therapy for Chronic TBI
Official title: The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Umbilical Cord Blood
Allogeneic
Traumatic Brain Injury
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Short-term Memory Function
timeFrame: Baseline - 6 months
Secondary outcomes:
measure: Changes in Global Outcome
timeFrame: Baseline - 6 months
measure: Changes in Intelligence
timeFrame: Baseline - 6 months
measure: Changes in Frontal Lobe Function
timeFrame: Baseline - 6 months
measure: Changes in Traumatic Brain Injury-related Symptoms
timeFrame: Baseline - 6 months
measure: Changes in Attention
timeFrame: Baseline - 6 months
measure: Changes in Behavior
timeFrame: Baseline - 6 months
measure: Changes in Emotion and Personality
timeFrame: Baseline - 6 months
measure: Changes in Motor Function and Activities of Daily Living
timeFrame: Baseline - 6 months
measure: Changes in Brain Structure
timeFrame: Baseline - 6 months
measure: Changes in Brain Glucose Metabolism
timeFrame: Baseline - 2 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: Minyoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: