Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury
This study is currently recruiting participants.
Verified June 2012 by Bukwang Pharmaceutical
Sponsor:
Bukwang Pharmaceutical
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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
Contacts and Locations
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 Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013