Effect of autograft/allograft combination of bone marrow stem cells and Schwann cells on complete chronic and subacute spinal cord injuries.

Evaluation of the efficacy of autograft/allograft stem cells and schwann cells transplantation in patients with complete chronic and subacute spinal cord injuries: A phase II randomized controlled study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200502047277N8

Enrollment

Registered

2022-06-12

Start date

2022-06-21

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Cronic and subacute 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 from the patient or allograft stem cells from the umbilical cord, and Schwann cells were

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 60 Root lesion less than three levels 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 Amputation Brain damage

Design outcomes

Primary

Measure	Time frame
Mean of the motor score of the American Spinal Injury Association Impairment Scale. Timepoint: Before treatment, 6, and 12 months after injury. Method of measurement: Physical examination.;Mean of the sensory score of the American Spinal Injury Association Impairment Scale. Timepoint: Before treatment, 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, 6, and 12 months after injury. Method of measurement: Spinal Cord Independence Measure III questionnaire.;Quality life of the patients. Timepoint: Before treatment and 6 months after injury. Method of measurement: WHOQOL-BREF Quality of Life questionnaire.;Pain of the patients. Timepoint: Before treatment and 6 months after injury. Method of measurement: Questionnaire of the International SCI Pain Basic Data Set (ISCIPBDS) version 2.;Neurogenic bowel dysfunction score. Timepoint: Before treatment and 6 months after injury. Method of measurement: Questionnaire of neurogenic bowel dysfunction.;Level of the constipation of the patients. Timepoint: Before treatment and 6 months after injury. Method of measurement: Cleavland constipation questionnaire.;Incontinence quality of life. Timepoint: Before treatment and 6 months after injury. Method of measurement: Incontinence quality of life questionnaire.;Urinary Tract Function. Timepoint: Before treatment and 6 months after injury. Method of measurement: INTERNATIONAL SPINAL CORD INJURY LOWER URINARY TRACT FUNCTION BASIC DATA SET Questionnaire.;Diffusion tensor imaging and fiber tractography of spine and brain. Timepoint: Before treatment and 6 months after injury. Method of measurement: Diffusion tensor imaging and fiber tractography.	—

Measure

Time frame

Mean of the motor score of the American Spinal Injury Association Impairment Scale. Timepoint: Before treatment, 6, and 12 months after injury. Method of measurement: Physical examination.;Mean of the sensory score of the American Spinal Injury Association Impairment Scale. Timepoint: Before treatment, 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, 6, and 12 months after injury. Method of measurement: Spinal Cord Independence Measure III questionnaire.;Quality life of the patients. Timepoint: Before treatment and 6 months after injury. Method of measurement: WHOQOL-BREF Quality of Life questionnaire.;Pain of the patients. Timepoint: Before treatment and 6 months after injury. Method of measurement: Questionnaire of the International SCI Pain Basic Data Set (ISCIPBDS) version 2.;Neurogenic bowel dysfunction score. Timepoint: Before treatment and 6 months after injury. Method of measurement: Questionnaire of neurogenic bowel dysfunction.;Level of the constipation of the patients. Timepoint: Before treatment and 6 months after injury. Method of measurement: Cleavland constipation questionnaire.;Incontinence quality of life. Timepoint: Before treatment and 6 months after injury. Method of measurement: Incontinence quality of life questionnaire.;Urinary Tract Function. Timepoint: Before treatment and 6 months after injury. Method of measurement: INTERNATIONAL SPINAL CORD INJURY LOWER URINARY TRACT FUNCTION BASIC DATA SET Questionnaire.;Diffusion tensor imaging and fiber tractography of spine and brain. Timepoint: Before treatment and 6 months after injury. Method of measurement: Diffusion tensor imaging and fiber tractography.

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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