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Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain

CompletedPhase 1, Phase 2NCT04530071
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)

The purpose of this clinical study is to evaluate the safety, tolerability, and efficacy of CordSTEM-DD, an allogeneic umbilical cord-derived mesenchymal stem cell, as a cell-therapeutic drug in patients with chronic low back pain due to lumbar intervertebral disc degeneration.

Study details

Official title
A Randomized, Double-blind, Placebo-controlled, Phase 1/2a, Multi-center Clinical Trial for Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain Due to Lumbar Intervertebral Disc Degeneration
Conditions
Interventions
  • Biological: CordSTEM-DD (0.7 x 10^7 cells)
  • Biological: CordSTEM-DD (2.1 x 10^7 cells)
  • Biological: Placebo
Sponsor
CHABiotech CO., Ltd
Collaborators
Seoul CRO Co., Ltd.
Start date
2020-09-21
Primary completion
2023-04-17
Sex
All
Age range
from 19 Years to 69 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: 1. Male and females aged ≥ 19 years and \< 70 years 2. Have low back or hip pain that has lasted ≥ 6 months at the time of screening and do not respond to conservative therapy\* given for ≥ 3 months \* Conservative therapy: Rest at an early stage, drug treatment (e.g., anti-inflammatory drugs, analgesics, anesthetics, narcotic analgesics, muscle relaxants), massage, acupuncture, chiropractic treatment, posture correction, home lumbar exercise programs, etc. 3. The Oswestry Disability Index (ODI) of 30% or greater and below 90% at screening 4. The Visual Analogue Scale (VAS) score for pain in the lumbar spine of ≥ 40 mm and ≤ 90 mm in the last 3 months prior to screening 5. The magnetic resonance imaging (MRI) grade 3 to 6 between lumbar vertebra 1 and sacral vertebra 1 according to the modified Pfirrmann classification method at screening 6. One pain-causing degenerative lumbar disc identified at screening. However, degenerative lumbar discs causing pain are identified by discography. 7. Those who provide written consent to comply with the precautions after they or their representatives voluntarily decide to participate subsequent to listening to a detailed explanation of this clinical study and understanding it completely Exclusion Criteria: 1. Body mass index (BMI) of 30 ㎏/m2 or greater 2. Those who require surgery because they have symptoms of nerve compression due to severe lumbar spinal stenosis or lumbar herniated nucleus pulposus 3. Those with spinal instability, spondylitis, or vertebral fractures 4. Severe degenerative changes in the intervertebral disc leading to a 30% or more decrease in the height of the intervertebral disc 5. Those who have modic type 3 changes on MRI 6. Those with severe osteoporosis \* An average T score of -2.5 or less in the lumbar bone density test (DEXA, Dual-Energy X-ray Absorptiometry) 7. Those who have undergone procedures (electrocoagulation of the intervertebral disc, etc.) and surgery such as discectomy on the disc to be administered with the investigational product However, in the case of electrocoagulation, enrollment is allowed if the procedure was performed 3 months prior to the administration of the investigational product on the annulus fibrosus, not on the nucleus pulposus. 8. Those who took at least 75 mg/day of morphine equivalent dose (MED) during the screening period 9. Those who have full-thickness annular tears (modified Dallas diagram scale grade 5) at index level when a contrast m…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04530071