CClinicalTrials.gg
Status unknownNCT05011474MANT3_ASCUpdated Aug 25, 2021

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 interventional study of administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3 in Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc, sponsored by Inbo Han. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-08-25.

Sponsored by Inbo Han · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2021, registered Aug 2021).
Phase
Phase 1/2
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
19 Years to 70 Years
Sex
All
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Study 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.

02

Conditions studied

  • Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc
03

In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's planned enrollment of 4 is below the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

Inbo Han is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Interventions

  • Biologicaladministered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3

    Adipose-derived mesenchymal stem cells isolated from subject's adipose tissue are pretreated with matrillin 3 and produced in spheroid form.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: During Clinical Trial Period

Secondary outcomes

  1. 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

    Time frame: before and at 1 week, 1, 3, 6 months after stem cell injection

  2. 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

    Time frame: before stem cell injection and at 1 week, 1, 3, and 6 months after injection

  3. 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

07

Study locations

1 site
  • CHA University, CHA Bundang Medical Center
    Seongnam-si, Gyeonggi-do, Korea, Republic of
08

References and documents

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05011474
Lead sponsor
Inbo Han
Responsible party
Inbo Han (Professor, Spine Neurosurgeon, Bundang CHA Hospital, CHA University) — Sponsor-investigator
First posted
Aug 18, 2021
Start date
Apr 23, 2021
Primary completion
Jan 20, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Aug 25, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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