The effect of combination therapy with mesenchymal stem cells and Schwann cells on urological parameters in patients with complete spinal cord injury

Effects of Intrathecal Transplantation of Autologous Schwann Cell and Bone Marrow Mesenchymal Stromal Cell on Urodynamic Parameters in Patients With Complete Spinal Cord Injury: Results From a Randomized Open-Label Phase 1/2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200502047277N4

Enrollment

Registered

2020-10-19

Start date

2020-07-01

Completion date

Unknown

Last updated

2023-03-13

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

Conditions

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

Interventions

Intervention 1: Intervention group: In this group, patients' stem cells were isolated by bone marrow aspiration and Schwann cells by removing part of the sural nerve and after culturing and preparing

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 60 Root lesion less than three level Complete spinal cord injury (class A in ASIA scale) The patient who fills informed consent

Exclusion criteria

Exclusion criteria: Systemic diseases like diabetes, Cancer, Advanced neuropathy, Myopathy, Neuromuscular disorder, etc. Epilepsy Concurrent lesions of peripheral nerve including traumatic lesion Brain damage

Design outcomes

Primary

Measure	Time frame
Bladder Maximum Capacity. Timepoint: Before and 6 months after treatment. Method of measurement: Urodynamic study.;Maximum Pressure of Detrusor in Filling. Timepoint: Before and 6 months after treatment. Method of measurement: Urodynamic study.;Maximum Pressure of Detrusor in Voiding. Timepoint: Before and 6 months after treatment. Method of measurement: Urodynamic study.;Bladder Compliance. Timepoint: Before and 6 months after treatment. Method of measurement: Urodynamic study.	—

Measure

Time frame

Bladder Maximum Capacity. Timepoint: Before and 6 months after treatment. Method of measurement: Urodynamic study.;Maximum Pressure of Detrusor in Filling. Timepoint: Before and 6 months after treatment. Method of measurement: Urodynamic study.;Maximum Pressure of Detrusor in Voiding. Timepoint: Before and 6 months after treatment. Method of measurement: Urodynamic study.;Bladder Compliance. Timepoint: Before and 6 months after treatment. Method of measurement: Urodynamic study.

—

Secondary

Measure	Time frame
Quality of Life. Timepoint: Before and 6 months after treatment. Method of measurement: Incontinence quality of life questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Oraee Yazdani

Shahid Beheshti University of Medical Sciences

saeed_o_yazdani@yahoo.com+98 21 25719

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026