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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Bukwang Pharmaceutical.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01624779
First received: June 18, 2012
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal stem cells in the patients with spinal cord injury, Phase I Clinical study.


Condition Intervention Phase
Spinal Cord Injury
Drug: autologous adipose tissue derived mesenchymal stem cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Intrathecal Transplantation of Autologous Adipose Tissue Derived Mesenchymal Stem Cells in the Patients With Spinal Cord Injury, Phase I Clinical Study

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Significant MRI Change before and after intervention [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Significant neurologic funtion Change before and after intervention [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Significant Electrophysiological Change before and after intervention [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Adverse event [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: autologous adipose tissue derived mesenchymal stem cells
    autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1&2
  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624779

Contacts
Contact: Taehyeong Jo, PhD 82-2-920-5550

Locations
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Seongbukgu, Korea, Republic of, 136-705
Contact: Taehyeong Jo, PhD    82-2-920-5550      
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
Principal Investigator: Taehyeong Jo, PhD Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01624779     History of Changes
Other Study ID Numbers: KOR-01
Study First Received: June 18, 2012
Last Updated: June 19, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bukwang Pharmaceutical:
autologous adipose tissue

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 29, 2014