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Allogeneic Umbilical Cord Blood Therapy for Chronic TBI

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ClinicalTrials.gov Identifier: NCT01451528
Recruitment Status : Withdrawn (The research fund, which is yet to be raised and expected to take for a while)
First Posted : October 13, 2011
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Traumatic Brain Injury Biological: Allogeneic Umbilical Cord Blood

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients
Study Start Date : July 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Allogeneic Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation
Biological: Allogeneic Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route
Other Name: Umbilical Cord Blood


Outcome Measures

Primary Outcome Measures :
  1. Changes in Short-term Memory Function [ Time Frame: Baseline - 6 months ]

Secondary Outcome Measures :
  1. Changes in Global Outcome [ Time Frame: Baseline - 6 months ]
  2. Changes in Intelligence [ Time Frame: Baseline - 6 months ]
  3. Changes in Frontal Lobe Function [ Time Frame: Baseline - 6 months ]
  4. Changes in Traumatic Brain Injury-related Symptoms [ Time Frame: Baseline - 6 months ]
  5. Changes in Attention [ Time Frame: Baseline - 6 months ]
  6. Changes in Behavior [ Time Frame: Baseline - 6 months ]
  7. Changes in Emotion and Personality [ Time Frame: Baseline - 6 months ]
  8. Changes in Motor Function and Activities of Daily Living [ Time Frame: Baseline - 6 months ]
  9. Changes in Brain Structure [ Time Frame: Baseline - 6 months ]
  10. Changes in Brain Glucose Metabolism [ Time Frame: Baseline - 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451528


Locations
Korea, Republic of
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Sponsors and Collaborators
Bundang CHA Hospital
Investigators
Principal Investigator: Minyoung Kim, M.D., Ph.D. CHA University
More Information

Responsible Party: MinYoung Kim, M.D., Associate Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT01451528     History of Changes
Other Study ID Numbers: TBIUCB
2011-141 ( Other Identifier: IRB of CHA Bundang Medical Center )
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014

Keywords provided by MinYoung Kim, M.D., Bundang CHA Hospital:
Umbilical Cord Blood
Allogeneic
Traumatic Brain Injury

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries