Safety investigation of simultaneous injection of olfactory ensheathing cells and mesenchymal stem cells in treatment of spinal cord injury

Safety assessment for co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in complete human spinal cord injury

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160110025930N2

Enrollment

Registered

2018-09-29

Start date

2018-10-06

Completion date

Unknown

Last updated

2020-08-17

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

Conditions

Spinal Cord Injury. Unspecified cord compression

Interventions

Intervention 1: Intervention group: Patients with complete spinal cord injury who are co-transplanted with autologous Olfactory Ensheathing Cells (OECs) (isolated from olfactory mucosa) and Mesenchyma

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Traumatic thoracic spinal cord injury Complete loss of sensory and motor function below the injury (ASIA Category A) Time from injury at least 6 months (chronic phase) No mental disturbances in patient Good patient motivation and cooperation and confirmation of written informed consent

Exclusion criteria

Exclusion criteria: Coexisting lesion of the nervous system Transection lesions of the spinal cord due to sharp objects Spinal stenosis in parts other than the damaged area Muscle atrophy or joint ossification Severe systemic disease such as neoplasm and diabetes Chronic sinusitis, tumors or polyps of nasal cavities and presented hyposmia which can prevent from mucosal biopsy

Design outcomes

Primary

Measure	Time frame
Type and amount of observed side effects due to the co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in patients with complete spinal cord injury in order to safety assessment for this intervention. Timepoint: 1, 6, and 12 months post cell transplantation. Method of measurement: 1-General physical assessments and laboratory tests like blood, serum, and urine analysis 2- Spinal radiological assessments with MRI imaging.	—

Measure

Time frame

Type and amount of observed side effects due to the co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in patients with complete spinal cord injury in order to safety assessment for this intervention. Timepoint: 1, 6, and 12 months post cell transplantation. Method of measurement: 1-General physical assessments and laboratory tests like blood, serum, and urine analysis 2- Spinal radiological assessments with MRI imaging.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoma Zamani

Tarbiat Modares University

homa.zamani@modares.ac.ir+98 21 8288 4507

Outcome results

None listed

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