Spinal Cord InjuryPhase 1/2NCT01769872
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury
A Phase 1/2 study testing Autologous Adipose Tissue derived MSCs Transplantation in people with Spinal Cord Injury, run by R-Bio at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with spinal cord injury 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 MSCs Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Jan 2016
- Phase
- Phase 1/2
- 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
- Subjects who understand and sign the consent form for this study
- Age : 19-70
- Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C)
- Duration of injury : > 3 month
Who cannot join
- Subjects who must put on a respirator
- Subjects who had malignant tumor within 5 years
- Subjects with a infectious disease include HIV and hepatitis
- Subjects who injured brain or spinal cord before spinal cord injury
- Subjects with anemia or thrombocytopenia
- Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
Show all 11Show fewer
- Subjects with congenital or acquired immunodeficiency disorders
- Patients with clouded consciousness or speech disorder
- treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
- participating another clinical trials within 3 months
- other serious disease or disorder that could seriously affect ability to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with spinal cord injury
- Conditions
- Spinal Cord Injury
- Being tested
- Autologous Adipose Tissue derived MSCs Transplantation
- 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 MSCs TransplantationProcedure or surgery
Intravenous injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e8 cells / 20mL Intrathecal injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 5x10e7 cells / 2mL Into a spinal cord injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e7 cells / 1mL
| Study group | Role | What they receive |
|---|---|---|
| Autologous Adipose Tissue derived MSCs | Experimental | Not described Receives: Procedure: Autologous Adipose Tissue derived MSCs Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASIA (American Spinal Injury Association) scale
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Measured: 32 weeks
Secondary outcomes (6)
Magnetic Resonance Imaging
To evaluate the change of treated spinal cord injury using Magnetic Resonance Imaging (MRI) at 3 and 6 months post injection of MSCs.
Measured: 32 weeks
MEP/SSEP
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Measured: 32 weeks
ADL (activities of daily living)
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Measured: 32 weeks
SF-36
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Measured: 32 weeks
ODI (Oswestry Disability Questionnaire)
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Measured: 32 weeks
Frequency of Adverse Events
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Korea University Anam Hospital
- Responsible party
- Sponsor
- Investigators
- Tai-Hyoung Cho, M.D. & Ph.D., Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769872
- Sponsor's protocol ID
- KSC-MSCs-SPI
- Status last verified
- Aug 2016
- First submitted
- 15 Jan 2013
- Last updated
- 2 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01769872
- Acronym / sponsor ID
- KSC-MSCs-SPI
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- R-BioIndustry (pharma, biotech, devices)
- Collaborators
- Korea University Anam Hospital
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- First posted
- 17 Jan 2013 (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 purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with spinal cord injury
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Adipose Tissue derived MSCs | Experimental | Procedure: Autologous Adipose Tissue derived MSCs Transplantation |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who understand and sign the consent form for this study
- Age : 19-70
- Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C)
- Duration of injury : > 3 month
Key exclusion criteria (11 listed)
- Subjects who must put on a respirator
- Subjects who had malignant tumor within 5 years
- Subjects with a infectious disease include HIV and hepatitis
- Subjects who injured brain or spinal cord before spinal cord injury
- Subjects with anemia or thrombocytopenia
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 MSCs TransplantationIntravenous injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e8 cells / 20mL Intrathecal injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 5x10e7 cells / 2mL Into a spinal cord injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e7 cells / 1mL | Procedure or surgery | Autologous Adipose Tissue derived MSCs |
Primary outcome
ASIA (American Spinal Injury Association) scale
Time frame: 32 weeks
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
6 secondary outcomes
Magnetic Resonance Imaging
Time frame: 32 weeks
MEP/SSEP
Time frame: 32 weeks
ADL (activities of daily living)
Time frame: 32 weeks
SF-36
Time frame: 32 weeks
ODI (Oswestry Disability Questionnaire)
Time frame: 32 weeks
Frequency of Adverse Events
Time frame: 32 weeks
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 2 Aug 2016.
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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.
Tai-Hyoung Cho, M.D. & Ph.D. 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 1/2 study testing Autologous Adipose Tissue derived MSCs Transplantation in people with Spinal Cord Injury, run by R-Bio 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 4 inclusion and 11 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 2 Aug 2016. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
ASIA (American Spinal Injury Association) scale (time frame: 32 weeks). 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 2 Aug 2016.