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
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Protocol summary
This study is a non-randomized, controlled, and open-label phase 1/2 pilot trial on 32 patients.
This study is a randomized, controlled, and open-label phase 1/2 trial on 32 patients.
This study is a non-randomized, controlled, and open-label phase 1/2 pilot trial on 32 patients.
این مطالعه یک کارآزمایی آزمایشی فاز 1/2 کنترل شده، برچسب باز و غیر تصادفی روی 32 بیمار است.
این مطالعه یک کارآزمایی فاز 1/2 کنترل شده، برچسب باز و تصادفی روی 32 بیمار است.
این مطالعه یک کارآزمایی آزمایشی فاز 1/2 کنترل شده، برچسب باز و غیر تصادفی روی 32 بیمار است.
General information
N/A
Randomized
narand
Natural urological changes in spinal cord injury patients over time will be a factor in the bias in the study results. Due to the nature of phase one and two of the article and the purpose of investigating the possible effectiveness of the intervention and creating reliable data for larger studies, including phase 3 trials, adding a control group to the intervention was necessary and important.
Natural urological changes in spinal cord injury patients over time will be a factor in the bias in the study results. Due to the nature of phase one and two of the article and the purpose of investigating the possible effectiveness of the intervention and creating reliable data for larger studies, including phase 3 trials, adding a control group to the intervention was necessary and important.
The patients in this study were randomly assigned with a sealed envelopes from the date of the first patient's enrollment, and the trial status was changed from non-randomized to randomized. The term of "pilot study" was removed from the title.
Natural urological changes in spinal cord injury patients over time will be a factor in the bias in the study results. Due to the nature of phase one and two of the article and the purpose of investigating the possible effectiveness of the intervention and creating reliable data for larger studies, including phase 3 trials, adding a control group to the intervention was necessary and important. The patients in this study were randomly assigned with a sealed envelopes from the date of the first patient's enrollment, and the trial status was changed from non-randomized to randomized. The term of "pilot study" was removed from the title.
تغییرات طبیعی اورولوژی بیماران ضایعات نخاعی در گذر زمان از عوامل ایجاد کننده ی سوگیری در بررسی نتایج مطالعه مورد نظر خواهد بود. با توجه به ماهیت فاز یک به دو بودن مقاله و هدف بررسی اثربخشی احتمالی مداخله و ایجاد داده های قابل اعتماد برای مطالعات بزرگتر از جمله کارآزمایی های فاز ۳ اضافه کردن گروه کنترل به مداخله لازم و مهم بوده.
تغییرات طبیعی اورولوژی بیماران ضایعات نخاعی در گذر زمان از عوامل ایجاد کننده ی سوگیری در بررسی نتایج مطالعه مورد نظر خواهد بود. با توجه به ماهیت فاز یک به دو بودن مقاله و هدف بررسی اثربخشی احتمالی مداخله و ایجاد داده های قابل اعتماد برای مطالعات بزرگتر از جمله کارآزمایی های فاز ۳ اضافه کردن گروه کنترل به مداخله لازم و مهم بوده.
بیماران در این مطالعه از تاریخ تایید ورود اولین بیمار با روش پاک سر بسته تصادفی سازی شده بودند که وضعیت کارآزمایی از حالت غیر تصادفی به تصادفی اصلاح گردید. کلمه ی مطالعه ی آزمایشی از عنوان برداشته شد.
تغییرات طبیعی اورولوژی بیماران ضایعات نخاعی در گذر زمان از عوامل ایجاد کننده ی سوگیری در بررسی نتایج مطالعه مورد نظر خواهد بود. با توجه به ماهیت فاز یک به دو بودن مقاله و هدف بررسی اثربخشی احتمالی مداخله و ایجاد داده های قابل اعتماد برای مطالعات بزرگتر از جمله کارآزمایی های فاز ۳ اضافه کردن گروه کنترل به مداخله لازم و مهم بوده. بیماران در این مطالعه از تاریخ تایید ورود اولین بیمار با روش پاک سر بسته تصادفی سازی شده بودند که وضعیت کارآزمایی از حالت غیر تصادفی به تصادفی اصلاح گردید. کلمه ی مطالعه ی آزمایشی از عنوان برداشته شد.
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 Non-Randomized Open-Label Phase 1/2 Pilot Study
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
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 Non-Randomized Open-Label Phase 1/2 Pilot Study
تأثیر تزریق اینتراتکال سلول های بنیادی مزانشیمال و سلول های شوان بر پارامترهای یوروداینامیکی در بیماران با آسیب نخاع کامل: نتایج حاصل از یک مطالعه آزمایشی فاز 1/2 برچسب باز غیر تصادفی
تأثیر تزریق اینتراتکال سلول های بنیادی مزانشیمال و سلول های شوان بر پارامترهای یوروداینامیکی در بیماران با آسیب نخاع کامل: نتایج حاصل از یک مطالعه آزمایشی فاز 1/2 برچسب باز تصادفی
تأثیر تزریق اینتراتکال سلول های بنیادی مزانشیمال و سلول های شوان بر پارامترهای یوروداینامیکی در بیماران با آسیب نخاع کامل: نتایج حاصل از یک مطالعه آزمایشی فاز 1/2 برچسب باز غیر تصادفی
Study subjects are divided into two equal groups by block randomization. The tool of randomization was sealed envelops.
Study subjects are divided into two equal groups by block randomization. The tool of randomization was sealed envelops.
افراد مطالعه توسط تصادفی سازی بلوک به دو گروه مساوی تقسیم می شوند. وسیله ی تصادفی سازی پاک های سربسته بود.
افراد مطالعه توسط تصادفی سازی بلوک به دو گروه مساوی تقسیم می شوند. وسیله ی تصادفی سازی پاک های سربسته بود.
Protocol summary
Study aim
Assessing the effect of intrathecal transplantation of combination of autologous Schwann cell and bone marrow mesenchymal stromal cell on urodynamic parameters in patients with complete spinal cord injury
Design
This study is a randomized, controlled, and open-label phase 1/2 trial on 32 patients.
Settings and conduct
This study includes 32 patients undergoing transplantation of a combination of autologous Schwann cell and bone marrow mesenchymal stem cell. Patients will be assessed in terms of the study outcomes before and 6 months after treatment
Participants/Inclusion and exclusion 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:
Systemic diseases like diabetes, Cancer, Advanced neuropathy, Myopathy, Neuromuscular disorder, etc.
Epilepsy
Concurrent lesions of peripheral nerve including traumatic lesion
Brain damage
Intervention groups
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 the cells, at a concentration of one million cells per milliliter through Lumbar punctures are transplanted.
Control group: Patients with complete spinal cord injury who were evaluated without intervention during the follow-up period.
Main outcome variables
Primary outcomes: Bladder Maximum Capacity, Maximum Pressure of Detrusor in Filling, Maximum Pressure of Detrusor in Voiding.
Secondary outcomes: Quality of Life
General information
Reason for update
Natural urological changes in spinal cord injury patients over time will be a factor in the bias in the study results. Due to the nature of phase one and two of the article and the purpose of investigating the possible effectiveness of the intervention and creating reliable data for larger studies, including phase 3 trials, adding a control group to the intervention was necessary and important.
The patients in this study were randomly assigned with a sealed envelopes from the date of the first patient's enrollment, and the trial status was changed from non-randomized to randomized. The term of "pilot study" was removed from the title.
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047277N4
Registration date:2020-10-19, 1399/07/28
Registration timing:registered_while_recruiting
Last update:2023-02-13, 1401/11/24
Update count:2
Registration date
2020-10-19, 1399/07/28
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
2020-07-01, 1399/04/11
Expected recruitment end date
2022-05-01, 1401/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of combination therapy with mesenchymal stem cells and Schwann cells on urological parameters in patients with complete spinal cord injury
Purpose
Treatment
Inclusion/Exclusion 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:
Systemic diseases like diabetes, Cancer, Advanced neuropathy, Myopathy, Neuromuscular disorder, etc.
Epilepsy
Concurrent lesions of peripheral nerve including traumatic lesion
Brain damage
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Study subjects are divided into two equal groups by block randomization. The tool of randomization was sealed envelops.
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
2020-06-30, 1399/04/10
Ethics committee reference number
IR.SBMU.MSP.REC.1399.153
Health conditions studied
1
Description of health condition studied
Complete spinal cord injuries
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Bladder Maximum Capacity
Timepoint
Before and 6 months after treatment
Method of measurement
Urodynamic study
2
Description
Maximum Pressure of Detrusor in Filling
Timepoint
Before and 6 months after treatment
Method of measurement
Urodynamic study
3
Description
Maximum Pressure of Detrusor in Voiding
Timepoint
Before and 6 months after treatment
Method of measurement
Urodynamic study
4
Description
Bladder Compliance
Timepoint
Before and 6 months after treatment
Method of measurement
Urodynamic study
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and 6 months after treatment
Method of measurement
Incontinence quality of life questionnaire
Intervention groups
1
Description
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 the cells, at a concentration of one million cells per milliliter through Lumbar punctures are transplanted.
Category
Treatment - Other
2
Description
Control group: Patients with complete spinal cord injury will be evaluated according the fullow up period without intervention
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
Assistant 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
Saeed Oraee Yazdani
Position
Assistant 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 updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roozbeh Tavanaei
Position
Research Associate
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
19899 , Shahrdari St, Tehran, Tehran Province, Iran.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2270 1022
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
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Details of statistical analysis results will be provided to applicants only
When the data will become available and for how long
starting 12 months after publication
To whom data/document is available
Principal investigator of other clinical trial.
Under which criteria data/document could be used
Only the results of statistical data analysis are allowed and raw data is not available to other researchers.
From where data/document is obtainable
Requests must be made via email saeed_o_yazdani@SBMU.ac.ir.
What processes are involved for a request to access data/document
The applicant must send the reason for his request and resume to the email saeed_o_yazdani@SBMU.ac.ir. After review by the principal researcher, the data will be provided to the applicant at its discretion.