search
Back to results

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

Primary Purpose

Lumbar Intervertebral Disc Degeneration

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous Adipose Tissue derived MSCs Transplantation
Sponsored by
R-Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Intervertebral Disc Degeneration

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Anam Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AdMSC

Arm Description

Autologous Adipose Tissue derived Mesenchymal Stem Cells

Outcomes

Primary Outcome Measures

Magnetic Resonance Imaging
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
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
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.

Full Information

First Posted
July 16, 2012
Last Updated
June 3, 2019
Sponsor
R-Bio
Collaborators
Korea University Anam Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01643681
Brief Title
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
Official Title
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No longer willing to continue clinical trials
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
Collaborators
Korea University Anam Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Intervertebral Disc Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AdMSC
Arm Type
Experimental
Arm Description
Autologous Adipose Tissue derived Mesenchymal Stem Cells
Intervention Type
Procedure
Intervention Name(s)
Autologous Adipose Tissue derived MSCs Transplantation
Intervention Description
Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL
Primary Outcome Measure Information:
Title
Magnetic Resonance Imaging
Description
To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Changes of Neurological Functions
Description
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.
Time Frame
24 weeks
Title
Safety evaluation
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs