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
To investigate the safety and efficacy of direct injection of mesenchymal stem cells derived from umbilical cord Wharton's jelly into the spinal cord lesion site on improving sensory-motor function and functional status of patients with traumatic spinal cord injury in the chronic or subacute phase.
Design
Clinical trial without control group, single, unblinded (due to the type of study and nature of the intervention), phase 1 on 10 patients
Settings and conduct
This study will be conducted on at least 10 patients with spinal cord injury who refer to Imam Khomeini Hospital in Sari.Due to the single-group design and the nature of the intervention, there is no possibility of blinding patients or investigators.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 18 and 60 years
Definite diagnosis of traumatic spinal cord injury with a specific lesion level (cervical or thoracic levels)
At least 3 months (subacute) or maximum 12 months (chronic) since the injury
Neurological functional score in levels A to C
Stable hemodynamic and metabolic status
Written informed consent
Exclusion criteria:
History of seizures or progressive neurological diseases
History of autoimmune disease or immunodeficiency
Active systemic or local infection
History of taking immunosuppressive or anticancer drugs
Pregnancy or breastfeeding
Non-cooperation in long-term follow-up
Intervention groups
Intervention group: Direct injection of approximately 1 to 2 million (per kilogram of body weight) of mesenchymal stem cells derived from umbilical cord Wharton's jelly into the spinal cord lesion site as a single injection for 30 minutes.
Main outcome variables
Injection safety, improvement of neurological function, improvement of daily and motor function, changes in spinal cord imaging, improvement of quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180826040869N4
Registration date:2026-05-05, 1405/02/15
Registration timing:prospective
Last update:2026-05-05, 1405/02/15
Update count:0
Registration date
2026-05-05, 1405/02/15
Registrant information
Name
Misagh Shafizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
mi.shafizad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-23, 1405/03/02
Expected recruitment end date
2026-07-25, 1405/05/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Organizational Research of Imam (RA) Sari Educational and Therapeutic Hospital
Street address
Imam Khomeini Hospital, Amir Mazandarani Street, Imam Square,
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2025-12-13, 1404/09/22
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1404.101
Health conditions studied
1
Description of health condition studied
Chronic and Subacute Traumatic Spinal Cord Injury
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
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
2
Description
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
3
Description
Spinal cord changes
Timepoint
At baseline, week 2, months 1, 3, 6, and 12
Method of measurement
MRI
4
Description
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)
Intervention groups
1
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Misagh Shafizad
Street address
Imam Khomeini Hospital, Amir Mazandarani Street, Imam Square
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3432 3434
Email
mi.shafizad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmadali Enayati
Street address
Moalem Square
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
ahmadali_enayati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Misagh Shafizad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Khomeini Hospital, Amir Mazandarani Street, Imam Square
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mi.shafizad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Misagh Shafizad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Khomeini Hospital, Amir Mazandarani Street, Imam Square
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mi.shafizad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Misagh Shafizad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Khomeini Hospital, Amir Mazandarani Street, Imam Square
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mi.shafizad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available