Back to resultsRepairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation
Primary Purpose
Lumbar Disc Herniation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge
The defect is sutured
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
Eligibility Criteria
Inclusion Criteria:
- Participants with signs and symptoms of lumbar disc herniation requiring surgical treatment after conservative management;
- Radiological data on CT/MRI obtained within a period prior to enrollment;
- Participants give written informed consent before enrollment.
Exclusion Criteria:
- If participants had an incomplete medical record;
- Participants had spine tumor, spine infection, previous underwent lumbar surgery, or revision surgery.
- Participants are taking uninterruptible anticoagulation therapy.
- Dementia and/or inability to give informed consent.
- MRI contraindication (e.g. cerebral aneurysm clips, cochlear implants, pacemaker, implanted biostimulators);
- Pregnancy;
- Participation in other clinical trial within the last 30 days.
Sites / Locations
- Tianjin HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
The defect is repaired and sutured
The defect is repaired but not sutured
The defect is sutured but not repaired
The defect is neither sutured nor repaired
Arm Description
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured.
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the second group, the defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge but not sutured after discectomy.
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the third group, the defect of intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the four group, the defect of intervertebral disc is neither sutured nor repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
Outcomes
Primary Outcome Measures
Changes from baseline in Oswestry Disability Index(ODI)
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Secondary Outcome Measures
Changes from baseline in Visual Analogue Scale(VAS)
Self reported pain using a 10-point visual analogue scale (0=no pain;10=pain as bad as can be)
Changes from baseline in The Short Form (36) Health Survey(SF-36)
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）
The Pfirrmann grading system assesses degenerated intervertebral discs by MRI for the asymmetry in disc structure, distinction of the nucleus and the annulus, signal intensity of intervertebral discs and height of intervertebral discs and assigns grade I to V for disc degeneration。
Change from Baseline in The Height of Disc on MRI Scans
Using imaging software, physicians will measure disc height at the treatment discs on the midline T1 sagittal view
Change from Baseline in The Size of Disc Protrusion
We will measure the anteroposterior (AP) size of the disc protrusions that required treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03002207
Brief Title
Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation
Official Title
A Prospective, Comparative Study to Evaluate Effectiveness of Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhanghao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this prospective study the investigators seek to evaluate clinical outcomes after repairing the defect of intervertebral disc with autologous BMSC/gelatin sponge during microendoscopic discectomy for participants of lumbar disc herniation.
Detailed Description
The participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured. In the second group, the defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge but not sutured after discectomy. In the third group, the defect of intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy. In the four group, the defect of intervertebral disc is neither sutured nor repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The defect is repaired and sutured
Arm Type
Experimental
Arm Description
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured.
Arm Title
The defect is repaired but not sutured
Arm Type
Experimental
Arm Description
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the second group, the defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge but not sutured after discectomy.
Arm Title
The defect is sutured but not repaired
Arm Type
Experimental
Arm Description
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the third group, the defect of intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
Arm Title
The defect is neither sutured nor repaired
Arm Type
No Intervention
Arm Description
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the four group, the defect of intervertebral disc is neither sutured nor repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
Intervention Type
Device
Intervention Name(s)
Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge
Intervention Description
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
Intervention Type
Procedure
Intervention Name(s)
The defect is sutured
Intervention Description
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect is sutured after discectomy.
Primary Outcome Measure Information:
Title
Changes from baseline in Oswestry Disability Index(ODI)
Description
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time Frame
Baseline, post-op 3 months, 6 months,12 months
Secondary Outcome Measure Information:
Title
Changes from baseline in Visual Analogue Scale(VAS)
Description
Self reported pain using a 10-point visual analogue scale (0=no pain;10=pain as bad as can be)
Time Frame
Baseline, post-op 3 months, 6 months,12 months
Title
Changes from baseline in The Short Form (36) Health Survey(SF-36)
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
Baseline, post-op 3 months, 6 months,12 months
Title
Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）
Description
The Pfirrmann grading system assesses degenerated intervertebral discs by MRI for the asymmetry in disc structure, distinction of the nucleus and the annulus, signal intensity of intervertebral discs and height of intervertebral discs and assigns grade I to V for disc degeneration。
Time Frame
Baseline, post-op 12 months
Title
Change from Baseline in The Height of Disc on MRI Scans
Description
Using imaging software, physicians will measure disc height at the treatment discs on the midline T1 sagittal view
Time Frame
Baseline, post-op 12 months
Title
Change from Baseline in The Size of Disc Protrusion
Description
We will measure the anteroposterior (AP) size of the disc protrusions that required treatment
Time Frame
Baseline, post-op 12 months
Other Pre-specified Outcome Measures:
Title
The Medical Records
Description
The Medical Records including operative time、blood loss and hospital stay
Time Frame
1 months after hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with signs and symptoms of lumbar disc herniation requiring surgical treatment after conservative management;
Radiological data on CT/MRI obtained within a period prior to enrollment;
Participants give written informed consent before enrollment.
Exclusion Criteria:
If participants had an incomplete medical record;
Participants had spine tumor, spine infection, previous underwent lumbar surgery, or revision surgery.
Participants are taking uninterruptible anticoagulation therapy.
Dementia and/or inability to give informed consent.
MRI contraindication (e.g. cerebral aneurysm clips, cochlear implants, pacemaker, implanted biostimulators);
Pregnancy;
Participation in other clinical trial within the last 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baoshan Xu
Phone
86-13502028198
Email
xubaoshan99@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Liu
Phone
86-13652006399
Email
yourliuyue@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinlong Ma
Organizational Affiliation
Tianjin Hospital Of Tianjin
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Hospital
City
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoshan Xu
Phone
86-13502028198
Email
xubaoshan99@126.com
First Name & Middle Initial & Last Name & Degree
Yue Liu
Phone
86-13652006399
Email
yourliuyue@126.com
First Name & Middle Initial & Last Name & Degree
Kaihui Zhang
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25708497
Citation
Sakai D, Andersson GB. Stem cell therapy for intervertebral disc regeneration: obstacles and solutions. Nat Rev Rheumatol. 2015 Apr;11(4):243-56. doi: 10.1038/nrrheum.2015.13. Epub 2015 Feb 24.
Results Reference
background
PubMed Identifier
25187512
Citation
Pettine KA, Murphy MB, Suzuki RK, Sand TT. Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells. 2015 Jan;33(1):146-56. doi: 10.1002/stem.1845.
Results Reference
background
PubMed Identifier
15995108
Citation
Hernigou P, Poignard A, Beaujean F, Rouard H. Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 2005 Jul;87(7):1430-7. doi: 10.2106/JBJS.D.02215.
Results Reference
background
PubMed Identifier
35468690
Citation
Yuan Q, Du L, Xu H, Zhang K, Li Q, Zhang H, Liu Y, Ma X, Xu B. Autologous Mesenchymal Stromal Cells Combined with Gelatin Sponge for Repair Intervertebral Disc Defect after Discectomy: A Preclinical Study in a Goat Model. Front Biosci (Landmark Ed). 2022 Apr 19;27(4):131. doi: 10.31083/j.fbl2704131.
Results Reference
derived
Learn more about this trial
Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation
We'll reach out to this number within 24 hrs