Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation

December 21, 2024 updated by: Zhanghao

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Tianjin, China, 300211
        • Tianjin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants with signs and symptoms of lumbar disc herniation requiring surgical treatment after conservative management;
  2. Radiological data on CT/MRI obtained within a period prior to enrollment;
  3. Participants give written informed consent before enrollment.

Exclusion Criteria:

  1. If participants had an incomplete medical record;
  2. Participants had spine tumor, spine infection, previous underwent lumbar surgery, or revision surgery.
  3. Participants are taking uninterruptible anticoagulation therapy.
  4. Dementia and/or inability to give informed consent.
  5. MRI contraindication (e.g. cerebral aneurysm clips, cochlear implants, pacemaker, implanted biostimulators);
  6. Pregnancy;
  7. Participation in other clinical trial within the last 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The defect is repaired 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 first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured.
Device: Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge
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.
Procedure: The defect is sutured
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect is sutured after discectomy.
Experimental: The defect is repaired but not 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.
Device: Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge
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.
Experimental: The defect is sutured but not repaired
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.
Procedure: The defect is sutured
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect is sutured after discectomy.
No Intervention: The defect is neither sutured nor repaired
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in Oswestry Disability Index(ODI)
Time Frame: Baseline, post-op 3 months, 6 months,12 months
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.
Baseline, post-op 3 months, 6 months,12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in Visual Analogue Scale(VAS)
Time Frame: Baseline, post-op 3 months, 6 months,12 months
Self reported pain using a 10-point visual analogue scale (0=no pain;10=pain as bad as can be)
Baseline, post-op 3 months, 6 months,12 months
Changes from baseline in The Short Form (36) Health Survey(SF-36)
Time Frame: Baseline, post-op 3 months, 6 months,12 months
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.
Baseline, post-op 3 months, 6 months,12 months
Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）
Time Frame: Baseline, post-op 12 months
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。
Baseline, post-op 12 months
Change from Baseline in The Height of Disc on MRI Scans
Time Frame: Baseline, post-op 12 months
Using imaging software, physicians will measure disc height at the treatment discs on the midline T1 sagittal view
Baseline, post-op 12 months
Change from Baseline in The Size of Disc Protrusion
Time Frame: Baseline, post-op 12 months
We will measure the anteroposterior (AP) size of the disc protrusions that required treatment
Baseline, post-op 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Medical Records
Time Frame: 1 months after hospital discharge
The Medical Records including operative time、blood loss and hospital stay
1 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhanghao

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Xinlong Ma, Tianjin Hospital Of Tianjin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016(001)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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