Spinal Cord InjuryPhase 1NCT01624779
Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury
A Phase 1 study testing autologous adipose tissue derived mesenchymal stem cells in people with Spinal Cord Injury, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- autologous adipose tissue derived mesenchymal stem cells
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Anam Hospital
Seoul, Seongbukgu, 136-705
About this study
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
The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal stem cells in the patients with spinal cord injury, Phase I Clinical study.
- Conditions
- Spinal Cord Injury
- Being tested
- autologous adipose tissue derived mesenchymal stem cells
- Keywords
- autologous adipose tissue
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous adipose tissue derived mesenchymal stem cellsDrug
autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1\&2
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant MRI Change before and after intervention
Measured: 6 month
Secondary outcomes (3)
Significant neurologic funtion Change before and after intervention
Measured: 6 month
Significant Electrophysiological Change before and after intervention
Measured: 6 month
Adverse event
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taehyeong Jo, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624779
- Sponsor's protocol ID
- KOR-01
- Status last verified
- Jun 2012
- First submitted
- 18 Jun 2012
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01624779
- Acronym / sponsor ID
- KOR-01
- Conditions
- Spinal Cord Injury
- Keywords
- autologous adipose tissue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous adipose tissue derived mesenchymal stem cellsautologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1\&2 | Drug | – |
Primary outcome
Significant MRI Change before and after intervention
Time frame: 6 month
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taehyeong Jo, PhD principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous adipose tissue derived mesenchymal stem cells in people with Spinal Cord Injury, run by Bukwang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant MRI Change before and after intervention (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.