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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Changes in Short-term Memory Function
Time frame: Baseline - 6 months
Changes in Global Outcome
Time frame: Baseline - 6 months
Changes in Intelligence
Time frame: Baseline - 6 months
Changes in Frontal Lobe Function
Time frame: Baseline - 6 months
Changes in Traumatic Brain Injury-related Symptoms
Time frame: Baseline - 6 months
Changes in Attention
Time frame: Baseline - 6 months
Changes in Behavior
Time frame: Baseline - 6 months
Changes in Emotion and Personality
Time frame: Baseline - 6 months
Changes in Motor Function and Activities of Daily Living
Time frame: Baseline - 6 months
Changes in Brain Structure
Time frame: Baseline - 6 months
Changes in Brain Glucose Metabolism
Time frame: Baseline - 2 weeks
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