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:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04288934
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-70 years
* Complete SCI grade AIS-A or -B, or incomplete C
* SCI between cervical levels C5 and thoracic level T11
* At least 12 weeks since time of injury
* Prediction rule score of 10 or less
* Cognitively unaffected
* Motivated for stem cell transplantation
Exclusion Criteria:
* Reduced cognition
* Age under 18 years or above 70 years
* Significant osteoporosis in spine and/or joints
* Pregnancy (Adequate contraceptive use is required for women in fertile age)
* Anoxic brain injury
* Neurodegenerative diseases
* Evidence of meningitis
* Positive serology for HIV, HBV, HCV, or Syphilis.
* Medical Complications that contraindicate surgery, including major respiratory complications.
* Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate MRI.
* Other medical conditions which can interfere with stem cell transplantation
* Inability to provide informed consent.
* Uncorrected vision
* Cardiac abnormalities and uncontrolled hypertension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04288934
Study Brief:
Protocol Section:
NCT04288934