Long-term follow-up study after '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: jRCT1010230005

Registered date:29/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Combined lumbar canal stenosis
• Date of first enrollment: 09/05/2023
• Target sample size: 45
• Study type: Observational

Outcome(s)

Primary Outcome

1)Safety
Adverse events occurring from 48 weeks to 96 weeks after the surgical treatment will be summarized with laboratory tests used as a safety assessment. The incidence of adverse events undeniably related to the investigational product in the physician-initiated clinical trial will be evaluated in the REC-02-dMD-001 implantation group, the dMD-001 implantation group, and the herniaectomy group.

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), T1 mapping, T2* mapping, DWI) will be conducted.

Secondary Outcome

1) JOA score
2) SF-36
3) ODI
4) RDQ
5) JOABPEQ
6) Zurich Lameness Questionnaire

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Willingness to provide written informed consent, fill in all necessary questionnaires, and return for follow-up.
• Exclude criteria: Any other reason judged by an investigator or clinical trial doctor that renders the candidate unsuitable for this clinical trial.

Related Information

• Primary Sponsor: Hideki Sudo
• Source(s) of Monetary Support: MOCHIDA PHARMACEUTICAL CO, LTD.