Effect of the combination of artificial dura and umbilical cord and placenta mesenchymal stem cell-derived exosomes in patients with complete spinal cord injury

Safety and Efficacy Assessment of Combination of Artificial Dura and Umbilical Cord and Placenta Mesenchymal Stem Cell-Derived Exosomes in Patients with Acute, Sub-acute and Chronic Complete Spinal Cord Injury: A Single-blinded Controlled Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200502047277N1

Enrollment

Registered

2020-10-02

Start date

2020-09-02

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete spinal cord injury. Injury of spinal cord, level unspecified

Interventions

Intervention 1: Intervention group: In this group, patients underwent spinal decompression surgery in the injured area and the patient's dura will be repaired by artificial dura made of polyethylene t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Traumatic spinal cord injury Time from injury up to 36 months Complete spinal cord injury (class A in ASIA scale) Written informed consent

Exclusion criteria

Exclusion criteria: History of previous spinal surgery Amputation Having underlying diseases affecting the diagnosis and treatment process (such as: diabetes mellitus, osteopenia, spinal cord injury, etc.)

Design outcomes

Primary

Measure	Time frame
Motor score of the American Spinal Injury Association Impairment Scale. Timepoint: Before treatment, 3, 6, and 12 months after injury. Method of measurement: Physical examination.;Sensory score of the American Spinal Injury Association Impairment Scale. Timepoint: Before treatment, 3, 6, and 12 months after injury. Method of measurement: Physical examination.;Mean of the "Spinal Cord Independence Measure III" scores of patients. Timepoint: Before treatment, 3, 6, and 12 months after injury. Method of measurement: Spinal Cord Independence Measure III questionnaire.	—

Measure

Time frame

Motor score of the American Spinal Injury Association Impairment Scale. Timepoint: Before treatment, 3, 6, and 12 months after injury. Method of measurement: Physical examination.;Sensory score of the American Spinal Injury Association Impairment Scale. Timepoint: Before treatment, 3, 6, and 12 months after injury. Method of measurement: Physical examination.;Mean of the "Spinal Cord Independence Measure III" scores of patients. Timepoint: Before treatment, 3, 6, and 12 months after injury. Method of measurement: Spinal Cord Independence Measure III questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadhosein Akhlaghpasand

Shahid Beheshti University of Medical Sciences

akhlaghpasandm@yahoo.com+98 21 25719

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026