Allogeneic Umbilical Cord Blood Therapy for Chronic TBI

Bundang CHA Hospital

Status: Withdrawn

Conditions: Traumatic Brain Injury

Treatments: Biological: Allogeneic Umbilical Cord Blood

Study type: Interventional

Funder types: Other

Identifiers

NCT01451528

2011-141 (Other Identifier)

TBIUCB

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Allogeneic Umbilical Cord Blood

Experimental group

Description:

Allogeneic Umbilical Cord Blood Transplantation

Treatment:

Biological: Allogeneic Umbilical Cord Blood