Lumbar Intervertebral Disc DegenerationNCT01643681
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
A study testing Autologous Adipose Tissue derived MSCs Transplantation in people with Lumbar Intervertebral Disc Degeneration, 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 lumbar intervertebral disc degeneration. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Lumbar Intervertebral Disc Degeneration
- 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
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Dec 2015
- Phase
- Interventional
- 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, males and females
- Have chronic low back pain for at least 1 year
- Have failed 1 year of non-operative low back pain management
- Have degenerated intervertebral disc on T2-weighted MR images
- confirmed by positive discography
- Have significant lumbar instability at degenerated intervertebral disc
Who cannot join
- Have significant lumbar herniated intervertebral disc
- Women who are pregnant or breast feeding or planning to become pregnant during the study
- History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications
- Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus
- Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
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 lumbar intervertebral disc degeneration.
- Conditions
- Lumbar Intervertebral Disc Degeneration
- Being tested
- Autologous Adipose Tissue derived MSCs Transplantation
- Medical subject headings
- Intervertebral Disc Degeneration
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
Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL
| Study group | Role | What they receive |
|---|---|---|
| AdMSC | Experimental | Autologous Adipose Tissue derived Mesenchymal Stem Cells 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.
Magnetic Resonance Imaging
To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs.
Measured: 24 weeks
Secondary outcomes (2)
Changes of Neurological Functions
To evaluate the change of treated lumbar intervertebral discs using Muscle Test, Somatosensory Test, Deep Tendon Reflex and VAS (Visual Analogue Scale Score 0-10) at 6 months post injection of MSCs.
Measured: 24 weeks
Safety evaluation
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionDec 2015
Why it stopped: No longer willing to continue clinical trials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Intervertebral Disc DegenerationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Korea University Anam Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643681
- Sponsor's protocol ID
- KSC-MSCs-LIDD
- Status last verified
- Jun 2019
- First submitted
- 16 Jul 2012
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
- ClinicalTrials.gov ID
- NCT01643681
- Acronym / sponsor ID
- KSC-MSCs-LIDD
- Conditions
- Lumbar Intervertebral Disc Degeneration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer willing to continue clinical trials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- R-BioIndustry (pharma, biotech, devices)
- Collaborators
- Korea University Anam Hospital
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Jul 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 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 lumbar intervertebral disc degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AdMSC | Experimental | Procedure: Autologous Adipose Tissue derived MSCs TransplantationAutologous Adipose Tissue derived Mesenchymal Stem Cells |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who understand and sign the consent form for this study
- Age :19-70, males and females
- Have chronic low back pain for at least 1 year
- Have failed 1 year of non-operative low back pain management
- Have degenerated intervertebral disc on T2-weighted MR images
Key exclusion criteria (6 listed)
- Have significant lumbar herniated intervertebral disc
- Women who are pregnant or breast feeding or planning to become pregnant during the study
- History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications
- Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus
- Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study
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 TransplantationInto lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL | Procedure or surgery | AdMSC |
Primary outcome
Magnetic Resonance Imaging
Time frame: 24 weeks
To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs.
2 secondary outcomes
Changes of Neurological Functions
Time frame: 24 weeks
Safety evaluation
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Adipose Tissue derived MSCs Transplantation in people with Lumbar Intervertebral Disc Degeneration, 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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Jun 2019. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Magnetic Resonance Imaging (time frame: 24 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 5 Jun 2019.