Patients With Chronic Low Back Pain Due to Degenerative Lumbar DiscPhase 1/2MANT3_ASCNCT05011474
Safety and Efficacy Study of Matrilin-3 Pretreated Autologous Adipose Derived Mesenchymal Stem Cells Implantation in Chronic Low Back Pain Patients With Lumbar Intervertebral Disc Degeneration
A Phase 1/2 study testing administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3 in people with Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc, run by Inbo Han at 1 site in South Korea.
Trial summary
To investigate the safety and efficacy of autologous adipose-derived mesenchymal stem cell spheroids pretreated with matrillin-3 in chronic low back pain patients with lumbar intervertebral disc degeneration. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc
- What is being tested?
- administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3
- How many people
- 4 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Apr 2021to 31 Dec 2022
- 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
- Male and female patients aged 19-70 years
- Among the subjects with low back pain, conventional conservative treatment is performed, but the back pain or hip pain persists for more than 3 months, and it is determined that the cause of the back pain is a degenerative disc (MRI checks for a degenerative disc)
- Has Oswestry Disability score(ODI) ≥ 30%
- Has Visual Analogue Scale(VAS) ≥ 4
- Between lumbar 1-sacral 1, Magnetic Resonance Imaging (MRI) grade according to the Pfirrmann classification is 3~4.
- Has one or two degenerative lumbar discs identified by MRI (Confirmation of low back pain due to disc through various nerve block procedures.)
- Consent was prepared for stem cell administration
Who cannot join
- Patient requiring surgery due to severe pain in lower extremities due to severe nerve compression due to severe lumbar stenosis or prolapse of lumbar nucleus.
- patient with spinal instability, spondylitis, or vertebral fracture
- type 3 Modic change is in an endplate
- Patient whose disc height has decreased by more than 1/2 due to severe disc degenerative change
- Patient with severe osteoporosis (The average value of the T score in the lumbar spine bone density test is -2.5 or less)
- has undergone surgery, such as disc resection, on the disc to which the cells will be administered
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- Patient who received lumbar epidural steroid injection 3 weeks before cell administration
- Pregnant or lactating women
- Among female patients who are likely to become pregnant during the clinical trial, who do not use medically acceptable methods of contraception
- medically acceptable methods of contraception: condom, Oral contraception lasting for at least 3 months, Has received an infusion pill before 3 months, using an injectable or implantable contraceptive, or installed an intrauterine contraceptive device
- has a history of psychiatry or who are currently undergoing treatment, who judged that it is difficult to proceed with the clinical trial under the judgment of the researcher
- Patient with drug or alcohol addiction who cannot understand the purpose and method of this clinical trial
- Patient who participated in other clinical trials within 3 months prior to participation in the trial
- Patient who may affect this clinical trial due to serious medical conditions (hypertension not controlled by drugs, diabetes not controlled by drugs, cirrhosis, kidney failure, tumors)
- Patient with a history of malignant tumors within the last 5 years
- has a history of administration of cell therapy products
- Other persons who have clinically significant findings deemed inappropriate for this clinical trial due to medical judgment by the person in charge of the clinical trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA University, CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
About this study
To investigate the safety and efficacy of autologous adipose-derived mesenchymal stem cell spheroids pretreated with matrillin-3 in chronic low back pain patients with lumbar intervertebral disc degeneration.
- Being tested
- administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3Biological
Adipose-derived mesenchymal stem cells isolated from subject's adipose tissue are pretreated with matrillin 3 and produced in spheroid form.
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Adverse reaction and serious adverse reaction evaluation 2) laboratory inspection 3) Vital signs 4) Biochemical examination 5) Lumbar MRI 6) Monitoring systemic infection
It will be considered safe and tolerated in the absence of the following:
- Grade 3 (NCI grading system) or higher adverse reactions related to cell products
- Any evidence that the cells are contaminated with infectious substances
- Any evidence that cells show tumorigenic potential
Measured: During Clinical Trial Period
Secondary outcomes (3)
Confirmation of the degree of pain improvement in VAS
on a scale of 0 to 10, with 0 meaning no pain and 10 meaning the worst pain you can imagine
Measured: before and at 1 week, 1, 3, 6 months after stem cell injection
Confirmation of the degree of improvement in disability (ODI)
on a scale of 0 to 3, with 0 meaning no disability and 10 meaning severe disability
Measured: before stem cell injection and at 1 week, 1, 3, and 6 months after injection
Confirmation of increase in water content in the nucleus using MRI
Measured: before stem cell injection and at 1 and 6 month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start23 Apr 2021
- Primary completion20 Jan 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Chronic Low Back Pain Due to Degenerative Lumbar DiscStudies 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
- Model description
- This clinical trial is a Phase 1/2a, open and researcher-led clinical trial. Subjects will be enrolled in succession, signed informed consent, and administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3 to each eligible subject meeting all selection criteria.
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inbo Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inbo Han, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011474
- Sponsor's protocol ID
- 2018-10-013
- Acronym
- MANT3_ASC
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Matrilin-3 Pretreated Autologous Adipose Derived Mesenchymal Stem Cells Implantation in Chronic Low Back Pain Patients With Lumbar Intervertebral Disc Degeneration
- ClinicalTrials.gov ID
- NCT05011474
- Acronym / sponsor ID
- MANT3_ASC / 2018-10-013
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Inbo HanUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 20 Jan 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Aug 2021 (actual)
- 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.
To investigate the safety and efficacy of autologous adipose-derived mesenchymal stem cell spheroids pretreated with matrillin-3 in chronic low back pain patients with lumbar intervertebral disc degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- This clinical trial is a Phase 1/2a, open and researcher-led clinical trial. Subjects will be enrolled in succession, signed informed consent, and administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3 to each eligible subject meeting all selection criteria.
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients aged 19-70 years
- Among the subjects with low back pain, conventional conservative treatment is performed, but the back pain or hip pain persists for more than 3 months, and it is determined that the cause of the back pain is a degenerative disc (MRI checks for a degenerative disc)
- Has Oswestry Disability score(ODI) ≥ 30%
- Has Visual Analogue Scale(VAS) ≥ 4
- Between lumbar 1-sacral 1, Magnetic Resonance Imaging (MRI) grade according to the Pfirrmann classification is 3~4.
Key exclusion criteria (17 listed)
- Patient requiring surgery due to severe pain in lower extremities due to severe nerve compression due to severe lumbar stenosis or prolapse of lumbar nucleus.
- patient with spinal instability, spondylitis, or vertebral fracture
- type 3 Modic change is in an endplate
- Patient whose disc height has decreased by more than 1/2 due to severe disc degenerative change
- Patient with severe osteoporosis (The average value of the T score in the lumbar spine bone density test is -2.5 or less)
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 |
|---|---|---|
| administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3Adipose-derived mesenchymal stem cells isolated from subject's adipose tissue are pretreated with matrillin 3 and produced in spheroid form. | Biological | – |
Primary outcome
1) Adverse reaction and serious adverse reaction evaluation 2) laboratory inspection 3) Vital signs 4) Biochemical examination 5) Lumbar MRI 6) Monitoring systemic infection
Time frame: During Clinical Trial Period
It will be considered safe and tolerated in the absence of the following: * Grade 3 (NCI grading system) or higher adverse reactions related to cell products * Any evidence that the cells are contaminated with infectious substances * Any evidence that cells show tumorigenic potential
3 secondary outcomes
Confirmation of the degree of pain improvement in VAS
Time frame: before and at 1 week, 1, 3, 6 months after stem cell injection
Confirmation of the degree of improvement in disability (ODI)
Time frame: before stem cell injection and at 1 week, 1, 3, and 6 months after injection
Confirmation of increase in water content in the nucleus using MRI
Time frame: before stem cell injection and at 1 and 6 month after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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 Phase 1/2 study testing administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3 in people with Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc, run by Inbo Han 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 17 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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. 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?
Results are not available in the source record.
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?
1) Adverse reaction and serious adverse reaction evaluation 2) laboratory inspection 3) Vital signs 4) Biochemical examination 5) Lumbar MRI 6) Monitoring systemic infection (time frame: During Clinical Trial Period). 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 25 Aug 2021.