View older revisions Content changed at 2024-03-26, 1403/01/07

Protocol summary

Study aim
Evaluation of the efficacy of autograft/allograft stem cells and Schwann cells transplantation in patients with complete chronic and subacute spinal cord injuries
Design
This study is a controlled and open-label phase 2 clinical trial on 90 patients.
Settings and conduct
This study included 90 patients in two control and intervention groups who underwent a combination of autologous Schwann cell and autograft/allograft stem cells. Patients are evaluated for the results of the study before, 6, and 12 months after treatment.
Participants/Inclusion and exclusion 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: Systemic diseases like diabetes, Cancer, Advanced neuropathy, Myopathy, Neuromuscular disorder, etc. Epilepsy Concurrent lesions of peripheral nerve including traumatic lesion Amputation Brain damage
Intervention groups
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 extracted by removing part of the sural nerve. After culturing and preparing the cells, MSC cells were transplanted at a concentration of 1 million cells per ml and SC cells at a concentration of 1 million cells per ml prepared through a puncture lumbar in the L4 / L5 region.
Main outcome variables
Sensory and motor score of the American Spinal Injury Association Impairment Scale, Spinal Cord Independence Measure III, quality of life, pain, urinary function, quality of life dependent on urinary incontinence, neurogenic bowel dysfunction, diffusion tensor imaging and fiber tractography, and constipation in the patients

General information

Reason for update
The clinical trial method was conducted as randomized to increase the accuracy of the study.
Acronym
IRCT registration information
IRCT registration number: IRCT20200502047277N8
Registration date: 2022-06-12, 1401/03/22
Registration timing: prospective

Last update: 2024-03-26, 1403/01/07
Update count: 1
Registration date
2022-06-12, 1401/03/22
Registrant information
Name
saeed oraee yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 25719
Email address
saeed_o_yazdani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-21, 1401/03/31
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Effect of autograft/allograft combination of bone marrow stem cells and Schwann cells on complete chronic and subacute spinal cord injuries.
Purpose
Treatment
Inclusion/Exclusion 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:
Systemic diseases like diabetes, Cancer, Advanced neuropathy, Myopathy, Neuromuscular disorder, etc. Epilepsy Concurrent lesions of peripheral nerve including traumatic lesion Amputation Brain damage
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Study subjects are divided into two equal groups by block randomization. The tool of randomization was sealed envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences ,Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2011-10-11, 1390/07/19
Ethics committee reference number
IR.SBMU.MSP.REC.1401.053

Health conditions studied

1

Description of health condition studied
Cronic and subacute spinal cord injuries
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified

Primary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
Quality life of the patients
Timepoint
Before treatment and 6 months after injury.
Method of measurement
WHOQOL-BREF Quality of Life questionnaire

5

Description
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.

6

Description
Neurogenic bowel dysfunction score
Timepoint
Before treatment and 6 months after injury.
Method of measurement
Questionnaire of neurogenic bowel dysfunction

7

Description
Level of the constipation of the patients
Timepoint
Before treatment and 6 months after injury.
Method of measurement
Cleavland constipation questionnaire.

8

Description
Incontinence quality of life
Timepoint
Before treatment and 6 months after injury.
Method of measurement
Incontinence quality of life questionnaire

9

Description
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

10

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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 extracted by removing part of the sural nerve. After culturing and preparing the cells, MSC cells were transplanted at a concentration of 1 million cells per ml and SC cells at a concentration of 1 million cells per ml prepared through a puncture lumbar in the L4 / L5 region.
Category
Treatment - Other

2

Description
Control group: In this group, patients with spinal cord injury were treated with a standard physiotherapy and rehabilitation program.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Saeed Oraee Yazdani
Street address
Shohadaye Tajrish hospital, Tajrish Square.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Saeed_o_yazdani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Oraee Yazdani
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Shohadaye Tajrish Hospital, Tajrish Ave.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
saeed_o_yazdani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadhosein Akhlaghpasand
Position
Research Associate
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
19899 , Shahrdari St, Tehran, Tehran Province, Iran.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 919 844 5400
Email
akhlaghpasandm@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roozbeh Tavanaee
Position
Research Associate
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
19899 , Shahrdari St, Tehran, Tehran Province, Iran.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 919 844 5400
Email
rtavanaei@sbmu.ac.ir

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
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