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

NCT03002207 | Completed DMC

• 1 other identifier: 2016(001)
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, post-op 3 months, 6 months,12 months

Secondary Outcomes (5)

• Changes from baseline in Visual Analogue Scale(VAS)

  Baseline, post-op 3 months, 6 months,12 months

• Changes from baseline in The Short Form (36) Health Survey(SF-36)

  Baseline, post-op 3 months, 6 months,12 months

• Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）

  Baseline, post-op 12 months

• Change from Baseline in The Height of Disc on MRI Scans

  Baseline, post-op 12 months

• Change from Baseline in The Size of Disc Protrusion

  Baseline, post-op 12 months

Other Outcomes (1)

• The Medical Records

  1 months after hospital discharge

Study Arms (4)

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.

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.

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.

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.

Interventions

Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge DEVICE

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 repaired and sutured; The defect is repaired but not sutured

The defect is sutured PROCEDURE

Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect is sutured after discectomy.

The defect is repaired and sutured; The defect is sutured but not repaired

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhanghao: lead

Study Sites (1)

Tianjin Hospital

Tianjin, 300211, China

Location

Related Publications (4)

• 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.

  PMID: 25708497 BACKGROUND

• 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.

  PMID: 25187512 BACKGROUND

• 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.

  PMID: 15995108 BACKGROUND

• 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.

  PMID: 35468690 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Xinlong Ma

  Tianjin Hospital Of Tianjin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tianjin Hospital

Study Record Dates

• First Submitted: December 10, 2016
• First Posted: December 23, 2016
• Study Start: October 1, 2016
• Primary Completion: December 20, 2024
• Study Completion: December 22, 2024
• Last Updated: December 27, 2024

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)