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Allogeneic Umbilical Cord Blood Therapy for Chronic TBI

This study has been withdrawn prior to enrollment.
(The research fund, which is yet to be raised and expected to take for a while)
Sponsor:
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT01451528
First received: October 11, 2011
Last updated: April 2, 2014
Last verified: April 2014

October 11, 2011
April 2, 2014
July 2014
December 2015   (final data collection date for primary outcome measure)
Changes in Short-term Memory Function [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01451528 on ClinicalTrials.gov Archive Site
  • Changes in Global Outcome [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
  • Changes in Intelligence [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
  • Changes in Frontal Lobe Function [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
  • Changes in Traumatic Brain Injury-related Symptoms [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
  • Changes in Attention [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
  • Changes in Behavior [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
  • Changes in Emotion and Personality [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
  • Changes in Motor Function and Activities of Daily Living [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
  • Changes in Brain Structure [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
  • Changes in Brain Glucose Metabolism [ Time Frame: Baseline - 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Allogeneic Umbilical Cord Blood Therapy for Chronic TBI
The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Traumatic Brain Injury
Biological: Allogeneic Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route
Other Name: Umbilical Cord Blood
Experimental: Allogeneic Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation
Intervention: Biological: Allogeneic Umbilical Cord Blood
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01451528
TBIUCB, 2011-141
No
MinYoung Kim, M.D., Bundang CHA Hospital
Bundang CHA Hospital
Not Provided
Principal Investigator: Minyoung Kim, M.D., Ph.D. CHA University
Bundang CHA Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP