Clinical trial NCT01624779: Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spinal Cord Injury
Keywords: autologous adipose tissue
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-06-21
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Significant MRI Change before and after intervention
timeFrame: 6 month
Secondary outcomes:
measure: Significant neurologic funtion Change before and after intervention
timeFrame: 6 month
measure: Significant Electrophysiological Change before and after intervention
timeFrame: 6 month
measure: Adverse event
timeFrame: 6 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbukgu
Study officials:
affiliation: Korea University Anam Hospital
name: Taehyeong Jo, PhD
role: PRINCIPAL_INVESTIGATOR
References: