Clinical trial NCT03002207: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: Tianjin Hospital
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline in Oswestry Disability Index(ODI)
timeFrame: Baseline, post-op 3 months, 6 months,12 months
Secondary outcomes:
measure: Changes from baseline in Visual Analogue Scale(VAS)
timeFrame: Baseline, post-op 3 months, 6 months,12 months
measure: Changes from baseline in The Short Form (36) Health Survey(SF-36)
timeFrame: Baseline, post-op 3 months, 6 months,12 months
measure: Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）
timeFrame: Baseline, post-op 12 months
measure: Change from Baseline in The Height of Disc on MRI Scans
timeFrame: Baseline, post-op 12 months
measure: Change from Baseline in The Size of Disc Protrusion
timeFrame: Baseline, post-op 12 months
Other outcomes:
measure: The Medical Records
timeFrame: 1 months after hospital discharge
Locations:
city: Tianjin
country: China
facility: Tianjin Hospital
Study officials:
affiliation: Tianjin Hospital Of Tianjin
name: Xinlong Ma
role: STUDY_CHAIR
References:
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.
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.
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.
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.