ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Adipose Derived Stem Cell Therapy for Intervertebral Disc Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02338271
Recruitment Status : Unknown
Verified January 2015 by Inbo Han, Bundang CHA Hospital.
Recruitment status was:  Recruiting
First Posted : January 14, 2015
Last Update Posted : January 14, 2015
Sponsor:
Collaborator:
CHA University
Information provided by (Responsible Party):
Inbo Han, Bundang CHA Hospital

Brief Summary:
  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

Condition or disease Intervention/treatment Phase
Low Back Pain Other: autologous adipose derived mesenchymal stem cell Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
a single, open clinical trial

a single-group, open, investigator-initiated clinical study

: autologous adipose derived mesenchymal stem cell (2 x 10^7 cells/mL /vial or 4 x 10^7 cells/mL /vial) plus Tissuefill (hyaluronic acid derivatives) 1mL/syringe

Other: autologous adipose derived mesenchymal stem cell
autologous adipose derived mesenchymal stem cell (2 x 10^7 cells/mL /vial or 4 x 10^7 cells/mL /vial) and Tissuefill (hyaluronic acid derivatives) 1mL/syringe




Primary Outcome Measures :
  1. Evaluation of Safety and Tolerability (Adverse events) [ Time Frame: 12months ]

    The transplantation will be considered to be safe and tolerable, in the absence of the following types of counter evidence.

    - Adverse events of grade 3 (NCI grading system) or above related to the cell products/ any evidence that the cells were contaminated by pollutants / any evidence that the cells exhibit tumorigenic potential.

    Adverse events will be reported at 1, 3, 6, 9, and 12 months



Secondary Outcome Measures :
  1. Change in the T2 MRI signal intensity of the nucleus pulposus [ Time Frame: 12months ]
    Change in the T2 MRI signal intensity of the nucleus pulposus in autologous adipose derived mesenchymal stem cells at 6 and 12 months after the transplantation compared to before the transplantation

  2. Overall improvement in the Disc Height Index [ Time Frame: 12months ]
    Assessment of the overall improvement in the Disc Height Index at 6 and 12 months after the transplantation of autologous adipose derived mesenchymal stem cells, compared to before the transplantation

  3. improvement in Visual Analogue Scale (VAS) [ Time Frame: 12 months ]
    Change in the VAS at 1, 3, 6, 9, and 12 months after the transplantation of autologous adipose derived mesenchymal stem cells, compared to before the transplantation

  4. improvement in Oswestry Disability Index (ODI) [ Time Frame: 12 months ]
    Change in the ODI at 1, 3, 6, 9, and 12 months after the transplantation of autologous adipose derived mesenchymal stem cells, compared to before the transplantation

  5. improvement in Short Form-36 [ Time Frame: 12 months ]
    Change in the Short Form (SF)-36 at 1, 3, 6, 9, and 12 months after the transplantation of autologous adipose derived mesenchymal stem cells, compared to before the transplantation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 treatment, hepatocirrhosis, renal failure, tumor) that can affect the outcome of this clinical study.
  13. Subjects with any other clinically significant findings that renders the subject unsuitable for the clinical study, as judged by the investigator responsible for the clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338271


Contacts
Contact: Inbo Han, MD, PhD +82-31-780-5688 hanib@cha.ac.kr
Contact: Kyunghoon Min, MD +82-31-780-5688 minkh@chamc.co.kr

Locations
Korea, Republic of
CHA University, CHA Bundang Medical Center Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Contact: Inbo Han, MD, PhD    +82-31-780-5688    hanib@cha.ac.kr   
Sponsors and Collaborators
Inbo Han
CHA University
Investigators
Principal Investigator: Inbo Han, MD, PhD CHA Bundang Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Inbo Han, Associate Professor, Spine Neurosurgeon, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT02338271     History of Changes
Other Study ID Numbers: ADMSC-DD-Han
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by Inbo Han, Bundang CHA Hospital:
Low back pain
Mesenchymal stromal stem cell
Hyaluronic acid

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Intervertebral Disc Degeneration
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents