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Completed

NCT Number: NCT01624779

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

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

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam Hospital

Seoul, Seongbukgu, 136-705, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient who is under 19 years and over 70years
  • Patient who must use the mechanical ventilator
  • Patient who have a history of malignant tumor within 5 years
  • Patient who is having a infectious disease of including current hepatitis and HIV
  • Patient who had the brain or spinal cord injury before the spinal cord injury (confirm subject's history from their medical history)
  • Patient who is having a acute disease judged by principle investigator or having a fever over 38.0 ℃ at the vaccination day
  • Patient who is having an anemia or thrombopenia
  • 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)
  • Patient who is having a Congenital Immune Deficiency Syndrome or AIDS (confirm subject's history from their medical history)
  • Patient who is having an amyotrophia or joint atrophy
  • Patient who is having an disturbanace of consciousness or dysphrasia
  • Patient who is taking an immunosuppressive agents or corticosteroids agents or cytotoxic agents or needed administration
  • Patient who have experienced another clinical trials within 3 months involving this clinical trial
  • Patient who can't participate in this clinical trial having any opinion regarded as clinical significance judged by principle investigator

Treatment and study plan

autologous adipose tissue derived mesenchymal stem cells

Drug

autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1&2

Primary outcomes

  1. Significant MRI Change before and after intervention

    Time frame: 6 month

Secondary outcomes

  1. Significant neurologic funtion Change before and after intervention

    Time frame: 6 month

  2. Significant Electrophysiological Change before and after intervention

    Time frame: 6 month

  3. Adverse event

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2012
Registry last updated
Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.