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Trial record 38 of 56 for:    stem cell Spinal Cord Injury AND cells

Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01624779
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : February 13, 2015
Sponsor:
Information provided by (Responsible Party):
Bukwang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE June 18, 2012
First Posted Date  ICMJE June 21, 2012
Last Update Posted Date February 13, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2012)
Significant MRI Change before and after intervention [ Time Frame: 6 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01624779 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2012)
  • Significant neurologic funtion Change before and after intervention [ Time Frame: 6 month ]
  • Significant Electrophysiological Change before and after intervention [ Time Frame: 6 month ]
  • Adverse event [ Time Frame: 6 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury
Official Title  ICMJE The Effect of Intrathecal Transplantation of Autologous Adipose Tissue Derived Mesenchymal Stem Cells in the Patients With Spinal Cord Injury, Phase I Clinical Study
Brief Summary The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal stem cells in the patients with spinal cord injury, Phase I Clinical study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Drug: autologous adipose tissue derived mesenchymal stem cells
autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1&2
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 19, 2012)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient who don't have any possiblity of improving neurological function despite performed the optimal treatment after spinal cord injury
  2. No change in neurological function for 4weeks interval by at least 2 clincal medical specialists
  3. Patient who is able to give written informed consent of clinical trial about stemcells treatment

Exclusion Criteria:

  1. Patient who is under 19 years and over 70years
  2. Patient who must use the mechanical ventilator
  3. Patient who have a history of malignant tumor within 5 years
  4. Patient who is having a infectious disease of including current hepatitis and HIV
  5. Patient who had the brain or spinal cord injury before the spinal cord injury (confirm subject's history from their medical history)
  6. Patient who is having a acute disease judged by principle investigator or having a fever over 38.0 ℃ at the vaccination day
  7. Patient who is having an anemia or thrombopenia
  8. Patient who is having an angina, myocardial infarct, myocardiopathy, obstructive vessel disease, chronic renal failure, glomerulopathy and chronic obstruent lung disease (confirm subject's history from their medical history)
  9. Patient who is having a Congenital Immune Deficiency Syndrome or AIDS (confirm subject's history from their medical history)
  10. Patient who is having an amyotrophia or joint atrophy
  11. Patient who is having an disturbanace of consciousness or dysphrasia
  12. Patient who is taking an immunosuppressive agents or corticosteroids agents or cytotoxic agents or needed administration
  13. Patient who have experienced another clinical trials within 3 months involving this clinical trial
  14. Patient who can't participate in this clinical trial having any opinion regarded as clinical significance judged by principle investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01624779
Other Study ID Numbers  ICMJE KOR-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bukwang Pharmaceutical
Study Sponsor  ICMJE Bukwang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Taehyeong Jo, PhD Korea University Anam Hospital
PRS Account Bukwang Pharmaceutical
Verification Date June 2012

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