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Autologous Adipose Derived Stem Cell Therapy for Intervertebral Disc Degeneration

Unknown statusPhase 1NCT02338271
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)

1. Subject: 10 patients : Chronic low back pain patients with lumbar intervertebral disc degeneration 2. Investigational Product : Autologous adipose derived mesenchymal stem cells plus hyaluronic acid derivatives (Tissuefill) 3. Time frame * 1 year

Study details

Official title
Safety and Efficacy Study of Autologous Adipose Derived Mesenchymal Stem Cells Implantation in Chronic Low Back Pain Patients With Lumbar Intervertebral Disc Degeneration
Conditions
Interventions
  • Other: autologous adipose derived mesenchymal stem cell
Sponsor
Inbo Han
Collaborators
CHA University
Organization
Bundang CHA Hospital
Start date
2015-01
Primary completion
2017-12
Sex
All
Age range
from 18 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: 1. Subjects who have experienced pain in the lower back or buttocks who have failed to respond to conservative therapies performed for a period of 3 months or longer. 2. Oswestry Disability Index of 30% or higher. 3. Visual Analogue Scale of 4 or higher. 4. Subjects who have received a Magnetic Resonance Imaging (hereinafter referred to as MRI) assessment of grades 3 to 4 for Lumbar 1 - Sacral 1, according to the Pfirrmann grading system. 5. Subjects who are assessed to have a similar degree of pain as usual when a discogram is performed on the degenerative lumbar disc(s) identified by MRI, having one or two discs that cause the pain. 6. Subjects who have signed the informed consent form for stem cell transplantation therapy. Exclusion Criteria: 1. Subjects with severe lumbar stenosis or herniated nucleus pulposus in the lumbar exhibiting symptoms of nerve compression and requiring surgery. 2. Subjects with spinal instability, spondylitis, or vertebral fractures 3. Patients with severe intervertebral disc degeneration that has resulted in a reduction of the disc height by ½ or more. 4. Subjects with severe osteoporosis (with an average T-score of -2.5 or below in the lumbar bone density test) 5. Patients who have received intra-discal procedures such as stem cell therapy or the injection of steroids into the disc or surgery such as discectomy on the disc on which the cell transplantation is planned to be performed. 6. Patients who have received a lumbar epidural steroid injection within a week prior to the cells transplantation. 7. Subjects who are hypersensitive to sodium hyaluronate. 8. Pregnant or breastfeeding women 9. Female patients with the possibility of pregnancy during the period of the clinical study who are not using a medically acceptable method of contraception. \* Medically acceptable methods of contraception: condoms, an oral contraceptive administered continually for at least 3 months, an implantable contraceptive surgically inserted 3 months prior to the clinical study, injected or inserted contraceptives, an intrauterine contraceptive device, etc. 10. Subjects with mental illness or a drug or alcohol addiction or subjects who are incapable of understanding the purpose and method of this clinical study. 11. Subjects who have participated in another clinical study in the 30 days prior to this study. 12. Subjects with a severe medical disease (hypertension unresponsive to drug treatment, diabetes unresponsive to drug tre…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02338271