JPRN-jRCT2013210076
Recruiting
Phase 2
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
Sudo Hideki0 sites45 target enrollmentMarch 18, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sudo Hideki
- Enrollment
- 45
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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.
Exclusion 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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Prophylaxis of lumbar spinal stenosis - associated muscle cramps by neuromuscular electrical stimulation: influence of different stimulation intensitiesM51.1R25.2M48.06Lumbar and other intervertebral disc disorders with radiculopathyCramp and spasmDRKS00011294Institut für Trainingswissenschaft und SportinformatikDeutsche Sporthochschule Köln32
Completed
Not Applicable
Helping Patients With Spinal Stenosis Make a Treatment Decision: A Randomized Study Assessing The Benefits of Health CoachingSpinal StenosisNCT01263678Dartmouth-Hitchcock Medical Center199
Completed
Not Applicable
Measuring the clinical validity of the nerve root sedimentation sign in magnetic resonance imaging for the diagnosis of lumbar spinal stenosisACTRN12610000567022Thomas Barz175
Completed
Phase 3
Surgical Versus Nonsurgical Treatment for Spinal StenosisSpinal StenosisNCT00022776University of Pittsburgh178
Active, not recruiting
Not Applicable
The NORDSTEN Studies/ The Spinal Stenosis StudyLumbar Spinal StenosisNCT02007083Haukeland University Hospital465