Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT04096950
Eligibility Criteria:
Inclusion Criteria:
Additional screening criteria check may apply for qualification:
* Provide written informed consent prior to beginning any study procedures
* Cervical spinal cord injury, ASIA impairment scale grade A, B, and C with the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological level of injury between C4 and C8
* Male or female subjects aged between 18 and 65 years
* Body mass index (BMI) \<35
* Has had stabilization surgery (if needed) following their SCI and prior to receiving MT-3921
Exclusion Criteria:
Additional screening criteria check may apply for qualification:
* Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations
* Poly-traumatic Injury as defined by Injury Severity Score (ISS) values \> 25
* Penetrating spinal cord injuries
* Traumatic transection of the spinal cord or spinal cord contusion size \> 3 cm determined by MRI
* Any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iInvestigator, may increase the risks associated with study participation
* Subjects with HIV, HBV or HCV positive
* Psychoactive substance use disorder
* History or presence of malignancy within the last 5 years prior to screening
* Pregnant or nursing women
* Subjects with hereditary fructose intolerance
* History of anaphylaxis or significant allergy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04096950
Study Brief:
Protocol Section:
NCT04096950