Evaluation of efficacy and safety of autologous bone marrow mesenchymal stem cells for traumatic spinal cord injury: Use-results comparative survey

JRCT ID: jRCT2053210130

Registered date:10/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Spinal Cord Injury
• Date of first enrollment: 16/05/2019
• Target sample size: 612
• Study type: Interventional
• Intervention(s): Intravenous infusion of autologous mesenchymal stem cells derived from bone marrow

Outcome(s)

Primary Outcome

Cohort 1:
Percentage of the case with 2 or more levels of AIS improvement from 6-8 weeks (49 +/- 7 days) to 180 days +/- 30 days after injury in AIS A patients aged 20 to 70 years with traumatic cervial spinal cord injury
Cohort 2:
Percentage of the case with 1 or more levels of AIS improvement from 6-8 weeks (49 +/- 7 days) to 180 days +/- 30 days after injury in AIS B or C patients aged 20 to 70 years with traumatic cervial spinal cord injury

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients using autologous mesenchymal stem cells derived from bone marrow for the first time for traumatic spinal cord injury
(2) Patients or their surrogates must provide informed consent before the start

• Exclude criteria: none

Related Information

• Primary Sponsor: Room Stemirac Information