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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

Unknown statusPhase 1, Phase 2NCT05011474
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

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
Conditions
  • Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc
Interventions
  • Biological: administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3
Sponsor
Inbo Han
Organization
CHA University
Start date
2021-04-23
Primary completion
2022-01-20
Sex
All
Age range
from 19 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
South Korea
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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: * 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…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05011474