Chronic and Subacute Traumatic Spinal Cord Injury. Injury of spinal cord, level unspecified
Conditions
Interventions
Intervention group: Receiving mesenchymal stem cells derived from Wharton's jelly of the umbilical cord at the site of the spinal cord lesion, approximately 1 to 2 million cells (per kilogram of body
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Definitive diagnosis of traumatic spinal cord injury with a specific level of injury (cervical or thoracic levels) At least 3 months (subacute) or a maximum of 12 months (chronic) have passed since the injury. Neurological Functional Score Level A to C Stable hemodynamic and metabolic status Written informed consent
Exclusion criteria
Exclusion criteria: History of seizures or progressive neurological diseases History of autoimmune disease or immunodeficiency Having an active systemic or local infection History of taking immunosuppressive or anticancer drugs Pregnancy or breastfeeding Lack of cooperation in long-term follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of direct injection of mesenchymal stem cells derived from umbilical cord Wharton's jelly into the spinal cord lesion site. Timepoint: Months 1, 3, 6 and 12. Method of measurement: Through clinical examination, routine tests, Magnetic Resonance Imaging (MRI), and patients' self-report. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improved neurological function (American Spinal Injury Association (ASIA) scale). Timepoint: At baseline, week 2, months 1, 3, 6, and 12. Method of measurement: History and clinical examination.;Improving daily and motor function. Timepoint: At baseline, week 2, months 1, 3, 6, and 12. Method of measurement: Barthel Index and Spinal Cord Independence Measure (SCIM) Index.;Spinal cord changes. Timepoint: At baseline, week 2, months 1, 3, 6, and 12. Method of measurement: MRI.;Improving the quality of life. Timepoint: At baseline, week 2, months 1, 3, 6, and 12. Method of measurement: World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMisagh Shafizad
Mazandaran University of Medical Sciences
Outcome results
None listed