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Trial record 2 of 48 for:    lumbar stem cell

Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Biostar.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643681
First Posted: July 18, 2012
Last Update Posted: March 26, 2014
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.
Collaborator:
Korea University Anam Hospital
Information provided by (Responsible Party):
Biostar
  Purpose
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with lumbar intervertebral disc degeneration.

Condition Intervention Phase
Lumbar Intervertebral Disc Degeneration Procedure: Autologous Adipose Tissue derived MSCs Transplantation Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration

Resource links provided by NLM:


Further study details as provided by Biostar:

Primary Outcome Measures:
  • Magnetic Resonance Imaging [ Time Frame: 24 weeks ]
    To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs.


Secondary Outcome Measures:
  • Changes of Neurological Functions [ Time Frame: 24 weeks ]
    To evaluate the change of treated lumbar intervertebral discs using Muscle Test, Somatosensory Test, Deep Tendon Reflex and VAS (Visual Analogue Scale Score 0-10) at 6 months post injection of MSCs.

  • Safety evaluation [ Time Frame: 24 weeks ]
    To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.


Estimated Enrollment: 8
Study Start Date: July 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Autologous Adipose Tissue derived MSCs Transplantation
    Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL
  Eligibility

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:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who understand and sign the consent form for this study
  • Age :19-70, males and females
  • Have chronic low back pain for at least 1 year
  • Have failed 1 year of non-operative low back pain management
  • Have degenerated intervertebral disc on T2-weighted MR images
  • confirmed by positive discography
  • Have significant lumbar instability at degenerated intervertebral disc

Exclusion Criteria:

  • Have significant lumbar herniated intervertebral disc
  • Women who are pregnant or breast feeding or planning to become pregnant during the study
  • History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications
  • Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus
  • Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
  Contacts and Locations
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): NCT01643681


Contacts
Contact: Tai-Hyoung Cho, M.D. & Ph.D. 82-10-3791-5338 choth2@korea.ac.kr

Locations
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Tai-Hyoung Cho, M.D. & Ph.D.    82-10-3791-5338    choth2@korea.ac.kr   
Principal Investigator: Tai-Hyoung Cho, M.D. & Ph.D.         
Sub-Investigator: Dong-Hyuk Park, M.D. & Ph.D.         
Sub-Investigator: Jang-Bo Lee, M.D. & Ph.D.         
Sub-Investigator: Sang-Heon Lee, M.D. & Ph.D.         
Sponsors and Collaborators
Biostar
Korea University Anam Hospital
  More Information

Responsible Party: Biostar
ClinicalTrials.gov Identifier: NCT01643681     History of Changes
Other Study ID Numbers: KSC-MSCs-LIDD
First Submitted: July 16, 2012
First Posted: July 18, 2012
Last Update Posted: March 26, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases