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IRCT20180826040869N4 IRCT 2026-05-05 Mazandaran University of Medical Sciences Evaluate the Safety and Efficacy of Wharton’s Jelly-Derived Mesenchymal Stem Cell Therapy on Sensory-Motor Function and Functional Status in Patients with Chronic and Subacute Traumatic Spinal Cord Injury: A Single-Arm Clinical Trial phase 1 Evaluate the Safety and Efficacy of Wharton’s Jelly-Derived Mesenchymal Stem Cell Therapy on Sensory-Motor Function and Functional Status in Patients with Chronic and Subacute Traumatic Spinal Cord Injury: A Single-Arm Clinical Trial phase 1 2026-05-23 anticipated 10 Complete https://irct.ir/trial/89684 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Chronic and Subacute Traumatic Spinal Cord Injury. 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 weight), once, for 30 minutes, injected. The cells are prepared from reliable sources and under good manufacturing principles and quality control.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Misagh Shafizad
Imam Khomeini Hospital, Amir Mazandarani Street, Imam Square
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 1700 mi.shafizad@gmail.com Mazandaran University of Medical Sciences scientific Misagh Shafizad
Imam Khomeini Hospital, Amir Mazandarani Street, Imam Square
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 1700 mi.shafizad@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both 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 T09.3 Injury of spinal cord, level unspecified Treatment - Other 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 weight), once, for 30 minutes, injected. The cells are prepared from reliable sources and under good manufacturing principles and quality control. 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. 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). Mazandaran University of Medical Sciences Approved 2025-12-13 Ethics Committee in Organizational Research of Imam (RA) Sari Educational and Therapeutic Hospital Imam Khomeini Hospital, Amir Mazandarani Street, Imam Square, Sari Mazandaran Iran (Islamic Republic of)