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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT02165904
Eligibility Criteria:
Inclusion Criteria:
1. Incomplete SCI
2. Neurological deficit clinically stable at least 12 months prior to treatment, and with a minimum of one-year evolution after SCI.
3. Neurophysiological confirmation of incomplete SCI.
4. The MRI study that morphologically evaluate the SCI.
5. Age between 18 and 70 years
6. Thread Men and women will compromise to use anticonceptive issues from first cell´s extraction to 6 months after last cell´s administration.
7. Ability to attend clinical follow-up and perform physical therapy through the treatment period.
8. Written and signed informed consent, according to the local regulation.
9. Hematologic and creatinin parameters, SGOT and SGPT, within the normal range, according to laboratory standards considering that small variations could be accepted based on clinical study team criteria.
Exclusion Criteria:
1. A classification in ASIA and FRANKEL clinical scales to evaluate the SCI.
2. Neurophysiological records that confirm the complete SCI.
3. Age below 18 years or above 70.
4. Pregnancy or lactation.
5. Malignancy disease diagnosed or treated within the last 5 years.
6. Patients with systemic disease that represents and additional risk to treatment.
7. Patients with uncertain commitment to follow the physical therapy and clinical visits as well as patient with a negative input in the previous phycological assessment.
8. Inability to assess the SCI features through MRI either noise due to spinal stabilization systems or any other cause.
9. Patients currently under hematopoietic growth factors treatment or who required or maintained anticoagulation.
10. Neurodegenerative disease additional.
11. History of substance abuse, psychiatric disease or allergy to the protein products used in the process of cell expansion.
12. Positive serology for HIV and syphilis.
13. Active Hepatitis B or Hepatitis C.
14. With other reason that would consider the patient ineligible for cell therapy according to the investigators judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02165904
Study Brief:
Protocol Section:
NCT02165904