Treatment of lumbar canal stenosis with a combination of ultra-purified, allogenic, bone marrow-derived, mesenchymal stem cells (REC) and in situ-forming gel: a multicentre, prospective, double blind, randomised, controlled trial

JRCT ID: jRCT2013210076

Registered date:18/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Combined lumbar canal stenosis
• Date of first enrollment: 15/05/2022
• Target sample size: 45
• Study type: Interventional
• Intervention(s): All participants undergo standard laminoplasty and discectomy for combined LSCS. In a part of the participants, a mixture of REC-02 and dMD-001(REC-02-dMD-001) solution or dMD-001 solution is implanted in the fenestration of the intervertebral disc and calcium chloride aqueous solution is applied to the surface of the solution to gelate the alginate.

Outcome(s)

Primary Outcome

1)Safety
Adverse events occurring 48 weeks after the surgical treatment will be summarized with laboratory tests used as a safety assessment. Safety will be evaluated by the incidence of adverse events.
2)Effectiveness
The respective pain scores (VAS) for low back pain and leg pain (for both the most painful leg and the contralateral leg) [5] and MRI imaging assessment (modified Pfirrmann classification, disc height index (DHI)) will be conducted.

Secondary Outcome

1) JOA score
2) SF-36
3) ODI
4) RDQ
5) JOABPEQ
6) Zurich Lameness Questionnaire
7) MRI image evaluation (T1p mapping, T2 * mapping, DWI)
8) Amount of hernia removed
9) Evaluation of burial

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1.Candidate for laminoplasty following lumbar discectomy for combined lumbar spinal canal stenosis (LSCS).
2. Radiographic findings corroborating symptoms of combined LSCS.
3. Condition unresponsive to six consecutive weeks of therapy or experiencing acute/uncontrolled leg pain, defined as a score >80 on the 100-mm visual analogue scale (VAS), in which higher scores represent worse pain.
4. Single-level combined LSCS.
5. Persistent and predominant leg pain (score >40 on the 100-mm VAS)
6. Age between 20 and 75 years (inclusive).
7. Willingness to provide written informed consent, fill in all necessary questionnaires, and return for follow-up.

Exclude criteria

1. Previous surgery involving a lumbar level.
2. Prior or planned spinal fusion involving a lumbar level.
3. Local kyphosis involving the affected disc level, evident on plain radiography of the lumbar spine in the flexion, neutral or extension position.
4. Intradiscal air pattern at the affected level.
5. Spondylolisthesis or retrolisthesis above grade 1 at the affected level.
6. IVD (height obtained by averaging the anterior and posterior heights of the IVD to be operated in the lumbar X-ray image in the neutral position) less than or equal to an average half of the adjacent caudal disc height.
7. History of treatment with condoliase.
8. Severe hypersensitivity to serum albumin or antibiotics.
9. Acute local or systemic infection.
10. Active malignancy or other similar comorbidities.
11. Current drug or alcohol dependency.
12. Current significant emotional disturbance.
13. Current fracture, tumour, and/or deformity of the lumbar spine.
14. Current or planned pregnancy.
15. Currently enrolled in other research that could confound the results of the present trial.
16. Presence of a metal implant or any other contraindication to magnetic resonance imaging (MRI).
17. Allergy to sodium alginate revealed upon skin prick testing.
18. Any other reason judged by an investigator or clinical trial doctor that renders the candidate unsuitable for this clinical trial.

Related Information

• Primary Sponsor: Sudo Hideki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,MOCHIDA PHARMACEUTICAL CO, LTD.