Lumbar Disc HerniationNCT03002207

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

A study testing Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and The defect is sutured in people with Lumbar Disc Herniation, run by Zhanghao at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Lumbar Disc Herniation
What is being tested?: Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and The defect is sutured
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteChina
Study dates: Oct 2016to 22 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Tianjin Hospital
Tianjin, 300211

Other trials in China

About this study

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

Read the 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.

Conditions: Lumbar Disc Herniation
Being tested: Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge, The defect is sutured
Medical subject headings: Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous Bone Marrow Stem Cell (BMSC)/gelatin spongeDevice
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.
The defect is suturedProcedure or surgery
Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect is sutured after discectomy.

Study groups in NCT03002207
Study group	Role	What they receive
The defect is repaired and sutured	Experimental	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. Receives: Device: Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge; Procedure: The defect is sutured
The defect is repaired but not sutured	Experimental	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. Receives: Device: Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge
The defect is sutured but not repaired	Experimental	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. Receives: Procedure: The defect is sutured
The defect is neither sutured nor repaired	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, post-op 3 months, 6 months,12 months

Secondary outcomes (5)

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)
Measured: Baseline, post-op 3 months, 6 months,12 months
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.
Measured: Baseline, post-op 3 months, 6 months,12 months
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。
Measured: Baseline, post-op 12 months
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
Measured: Baseline, post-op 12 months
Change from Baseline in The Size of Disc Protrusion
We will measure the anteroposterior (AP) size of the disc protrusions that required treatment
Measured: Baseline, post-op 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201622 Dec 2024

First posted23 Dec 2016 (estimated)
Study startOct 2016
Primary completion20 Dec 2024
Study completion22 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03002207
Sponsor's protocol ID: 2016(001)
Status last verified: Oct 2021
First submitted: 10 Dec 2016
Last updated: 27 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 25708497
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.
PubMed 25187512
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.
PubMed 15995108
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.
PubMed 35468690

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse

All Lumbar Disc Herniation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03002207
Acronym / sponsor ID: 2016(001)
Conditions: Lumbar Disc Herniation
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: ZhanghaoUniversity, hospital or other
Study start: Oct 2016 (actual)
Primary completion: 20 Dec 2024 (actual)
Study completion: 22 Dec 2024 (actual)
First posted: 23 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
The defect is repaired and sutured	Experimental	Device: Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge, Procedure: The defect is suturedParticipants 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.
The defect is repaired but not sutured	Experimental	Device: Autologous Bone Marrow Stem Cell (BMSC)/gelatin spongeParticipants 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.
The defect is sutured but not repaired	Experimental	Procedure: The defect is suturedParticipants 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.
The defect is neither sutured nor repaired	No intervention	–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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autologous Bone Marrow Stem Cell (BMSC)/gelatin spongeParticipants 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.	Device	The defect is repaired and sutured, The defect is repaired but not sutured
The defect is suturedParticipants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect is sutured after discectomy.	Procedure or surgery	The defect is repaired and sutured, The defect is sutured but not repaired

Primary outcome

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.

5 secondary outcomes

Changes from baseline in Visual Analogue Scale(VAS)
Time frame: 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
Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）
Time frame: Baseline, post-op 12 months
Change from Baseline in The Height of Disc on MRI Scans
Time frame: Baseline, post-op 12 months
Change from Baseline in The Size of Disc Protrusion
Time frame: Baseline, post-op 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Background: PubMed 25708497Sakai 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.
Background: PubMed 25187512Pettine 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.
Background: PubMed 15995108Hernigou 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.
Derived from this study: PubMed 35468690Yuan 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.
Individual participant dataSharing planned: No

Related trials for Lumbar Disc Herniation

Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xinlong Ma study chair

Tianjin Hospital Of Tianjin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and The defect is sutured in people with Lumbar Disc Herniation, run by Zhanghao at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline in Oswestry Disability Index(ODI) (time frame: Baseline, post-op 3 months, 6 months,12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03002207, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.