Safety and Efficacy Assessment of Combination of Artificial Dura and Exosome in Patients with Acute, Sub-acute and Chronic Complete Spinal Cord Injury: A Single-blinded Controlled Clinical Trial
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Protocol summary
Assessment of the combination of artificial dura and exosome in patients with acute and complete spinal cord injury.
Assessment of the combination of artificial dura and exosome in patients with complete spinal cord injury.
Assessment of the combination of artificial dura and exosome in patients with acute and complete spinal cord injury.
ارزیابی ترکیب دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب حاد و کامل نخاع.
ارزیابی ترکیب دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب کامل نخاع.
ارزیابی ترکیب دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب حاد و کامل نخاع.
This study is a non-randomized, controlled, three-arm parallel-group, phase 2 trial on 20 patients.
This study is a non-randomized, controlled, four-arm parallel-group, phase 2 trial on 20 patients.
This study is a non-randomized, controlled, threefour-arm parallel-group, phase 2 trial on 20 patients.
این مطالعه کارآزمایی غیر تصادفی، کنترل شده، سه بازوی موازی، فاز 2 روی 20 بیمار است.
این مطالعه کارآزمایی غیر تصادفی، کنترل شده، چهار بازوی موازی، فاز 2 روی 20 بیمار است.
این مطالعه کارآزمایی غیر تصادفی، کنترل شده، سهچهار بازوی موازی، فاز 2 روی 20 بیمار است.
This study includes 20 patients having acute complete spinal cord injury. All the patients will be followed their standard spinal surgery in the hospital and assigned non-randomly in three groups to receive new treatments. Patients will be assessed in terms of the study outcomes before treatment, 3, 6, and 12 months after injury.
This study includes 20 patients having acute complete spinal cord injury. All the patients will be followed their standard spinal surgery in the hospital and assigned non-randomly in four groups to receive new treatments. Patients will be assessed in terms of the study outcomes before treatment, 3, 6, and 12 months after injury.
This study includes 20 patients having acute complete spinal cord injury. All the patients will be followed their standard spinal surgery in the hospital and assigned non-randomly in threefour groups to receive new treatments. Patients will be assessed in terms of the study outcomes before treatment, 3, 6, and 12 months after injury.
این مطالعه شامل 20 بیمار مبتلا به آسیب حاد کامل نخاع است. بر روی همه بیماران جراحی استاندارد ستون فقرات در بیمارستان انجام می شود و به طور غیر تصادفی در سه گروه برای دریافت درمان های جدید قرار می گیرند. بیماران از نظر نتایج مطالعه قبل از درمان ، 3 ، 6 و 12 ماه پس از آسیب ارزیابی می شوند.
این مطالعه شامل 20 بیمار مبتلا به آسیب حاد کامل نخاع است. بر روی همه بیماران جراحی استاندارد ستون فقرات در بیمارستان انجام می شود و به طور غیر تصادفی در چهار گروه برای دریافت درمان های جدید قرار می گیرند. بیماران از نظر نتایج مطالعه قبل از درمان ، 3 ، 6 و 12 ماه پس از آسیب ارزیابی می شوند.
این مطالعه شامل 20 بیمار مبتلا به آسیب حاد کامل نخاع است. بر روی همه بیماران جراحی استاندارد ستون فقرات در بیمارستان انجام می شود و به طور غیر تصادفی در سهچهار گروه برای دریافت درمان های جدید قرار می گیرند. بیماران از نظر نتایج مطالعه قبل از درمان ، 3 ، 6 و 12 ماه پس از آسیب ارزیابی می شوند.
Inclusion criteria:
Traumatic spinal cord injury
Time from injury up to 6 months
Complete spinal cord injury (class A in ASIA scale)
Written informed consent
Exclusion criteria:
History of previous spinal surgery
Amputation
Having underlying diseases affecting the diagnosis and treatment process (such as diabetes mellitus, osteopenia, spinal cord injury, etc.)
Inclusion criteria:
Traumatic spinal cord injury
36 months have passed since the spinal cord injury
Complete spinal cord injury (class A in ASIA scale)
Written informed consent
Exclusion criteria:
History of previous spinal surgery
Amputation
Having underlying diseases affecting the diagnosis and treatment process (such as diabetes mellitus, osteopenia, spinal cord injury, etc.)
Inclusion criteria: Traumatic spinal cord injury Time from36 months have passed since the spinal cord injury up to 6 months Complete spinal cord injury (class A in ASIA scale) Written informed consent Exclusion criteria: History of previous spinal surgery Amputation Having underlying diseases affecting the diagnosis and treatment process (such as diabetes mellitus, osteopenia, spinal cord injury, etc.)
معیار های ورود:
آسیب تروماتیک طناب نخاعی
تا 6 ماه از مدت زمان آسیب
آسیب کامل نخاع (کلاس A در مقیاس ASIA)
دریافت رضایت آگاهانه
معیار های عدم ورود:
سابقه جراحی قبلی ستون فقرات
قطع عضو
ابتلا به بیماریهای زمینه ای اثر گذار بر تشخیص و پروسه درمان (مانند: دیابت شیرین، استئوپنی، آسیب ستون خلفی نخاع و ...)
معیار های ورود:
آسیب تروماتیک طناب نخاعی
تا ۳۶ ماه از آسیب نخاع گذشته باشد
آسیب کامل نخاع (کلاس A در مقیاس ASIA)
دریافت رضایت آگاهانه
معیار های عدم ورود:
سابقه جراحی قبلی ستون فقرات
قطع عضو
ابتلا به بیماریهای زمینه ای اثر گذار بر تشخیص و پروسه درمان (مانند: دیابت شیرین، استئوپنی، آسیب ستون خلفی نخاع و ...)
معیار های ورود: آسیب تروماتیک طناب نخاعی تا 6۳۶ ماه از مدت زمان آسیب نخاع گذشته باشد آسیب کامل نخاع (کلاس A در مقیاس ASIA) دریافت رضایت آگاهانه معیار های عدم ورود: سابقه جراحی قبلی ستون فقرات قطع عضو ابتلا به بیماریهای زمینه ای اثر گذار بر تشخیص و پروسه درمان (مانند: دیابت شیرین، استئوپنی، آسیب ستون خلفی نخاع و ...)
Patients in the present study will be non-randomly assigned to three groups including the patients treated with artificial dura and exosome group, the patients treated with artificial dura group, and the control group which receives the standard therapy.
Patients in the present study will be non-randomly assigned to three groups including the patients treated with artificial dura and exosome group, the patients treated with artificial dura group, patients treated with exosome alone, and the control group which receives the standard therapy.
Patients in the present study will be non-randomly assigned to three groups including the patients treated with artificial dura and exosome group, the patients treated with artificial dura group, patients treated with exosome alone, and the control group which receives the standard therapy.
بیماران در مطالعه حاضر به طور غیر تصادفی به سه گروه شامل گروه بیماران تحت درمان با دورای مصنوعی و اگزوزوم ، گروه بیماران تحت درمان با دوای مصنوعی و گروه شاهد كه درمان استاندارد دریافت می كنند ، تقسیم می شوند.
بیماران در مطالعه حاضر به طور غیر تصادفی به چهار گروه شامل گروه بیماران تحت درمان با دورای مصنوعی و اگزوزوم ، گروه بیماران تحت درمان با دورای مصنوعی، بیماران تحت درمان با اگزوزوم به تنهایی و گروه شاهد كه درمان استاندارد دریافت می كنند ، تقسیم می شوند.
بیماران در مطالعه حاضر به طور غیر تصادفی به سهچهار گروه شامل گروه بیماران تحت درمان با دورای مصنوعی و اگزوزوم ، گروه بیماران تحت درمان با دوایدورای مصنوعی، بیماران تحت درمان با اگزوزوم به تنهایی و گروه شاهد كه درمان استاندارد دریافت می كنند ، تقسیم می شوند.
General information
empty
According to the definition of the inclusion criteria, the patients who were initially included in the study had been up to six months since their injury, unfortunately, at the beginning of the study, only the word acute was written in the definitions of the protocol title, which has been corrected. On the other hand, to include patients with chronic phases, the time interval from the injury was changed to 36 months.
Due to the possible effects of exosome, we needed to add the exosome treatment group alone so that the clinical trial does not suffer from problems in terms of methodology and results, and the results of other groups can be compared with this group.
According to the definition of the inclusion criteria, the patients who were initially included in the study had been up to six months since their injury, unfortunately, at the beginning of the study, only the word acute was written in the definitions of the protocol title, which has been corrected. On the other hand, to include patients with chronic phases, the time interval from the injury was changed to 36 months. Due to the possible effects of exosome, we needed to add the exosome treatment group alone so that the clinical trial does not suffer from problems in terms of methodology and results, and the results of other groups can be compared with this group.
empty
بیمارانی که در ابتدا وارد مطالعه شده بودند طبق تعریف معیار ورود تا شش ماه از زمان آسیبشان گذشته بود که متاسفانه در ابتدای مطالعه در تعاریف عنوان پروتکل صرفا کلمه ی حاد نوشته شده بود که اصلاح شده. از طرفی جهت دربرگیری بیماران با فاز مزمن معیار ورود فاصله ی زمانی از آسیب به ۳۶ ماه تغییر یافت.
با توجه به اثرات احتمالی اگزوزوم نیازمند اضافه کردن گروه درمان با اگزوزوم به صورت تنها بودیم که کارآزمایی بالینی از جهت متدولوژی و نتایج دچار اشکال نشود و نتایج سایر گروه ها با این گروه نیز مقایسه شود.
بیمارانی که در ابتدا وارد مطالعه شده بودند طبق تعریف معیار ورود تا شش ماه از زمان آسیبشان گذشته بود که متاسفانه در ابتدای مطالعه در تعاریف عنوان پروتکل صرفا کلمه ی حاد نوشته شده بود که اصلاح شده. از طرفی جهت دربرگیری بیماران با فاز مزمن معیار ورود فاصله ی زمانی از آسیب به ۳۶ ماه تغییر یافت. با توجه به اثرات احتمالی اگزوزوم نیازمند اضافه کردن گروه درمان با اگزوزوم به صورت تنها بودیم که کارآزمایی بالینی از جهت متدولوژی و نتایج دچار اشکال نشود و نتایج سایر گروه ها با این گروه نیز مقایسه شود.
Effect of the combination of artificial dura and exosome in patients with acute and complete spinal cord injury
Effect of the combination of artificial dura and exosome in patients with complete spinal cord injury
Effect of the combination of artificial dura and exosome in patients with acute and complete spinal cord injury
اثر ترکیبی دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب حاد و کامل نخاع
اثر ترکیبی دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب کامل نخاع
اثر ترکیبی دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب حاد و کامل نخاع
Safety and Efficacy Assessment of Combination of Artificial Dura and Exosome in Patients with Acute and Complete Spinal Cord Injury: A Single-blinded Controlled Clinical Trial
Safety and Efficacy Assessment of Combination of Artificial Dura and Exosome in Patients with Acute, Sub-acute and Chronic Complete Spinal Cord Injury: A Single-blinded Controlled Clinical Trial
Safety and Efficacy Assessment of Combination of Artificial Dura and Exosome in Patients with Acute, Sub-acute and Chronic Complete Spinal Cord Injury: A Single-blinded Controlled Clinical Trial
ارزیابی ایمنی و کارآیی ترکیبی دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب حاد و کامل نخاع: یک کارآزمایی بالینی کنترل شده تک سو کور
ارزیابی ایمنی و کارآیی ترکیبی دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب حاد، تحت حاد و مزمن کامل نخاع: یک کارآزمایی بالینی کنترل شده تک سو کور
ارزیابی ایمنی و کارآیی ترکیبی دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب حاد، تحت حاد و مزمن کامل نخاع: یک کارآزمایی بالینی کنترل شده تک سو کور
Traumatic spinal cord injury
Time from injury up to 6 months
Complete spinal cord injury (class A in ASIA scale)
Written informed consent
Traumatic spinal cord injury
Time from injury up to 36 months
Complete spinal cord injury (class A in ASIA scale)
Written informed consent
Traumatic spinal cord injury Time from injury up to 636 months Complete spinal cord injury (class A in ASIA scale) Written informed consent
آسیب تروماتیک طناب نخاعی
تا 6 ماه از مدت زمان آسیب
آسیب کامل نخاع (کلاس A در مقیاس ASIA)
دریافت رضایت آگاهانه
آسیب تروماتیک طناب نخاعی
تا 36 ماه از مدت زمان آسیب
آسیب کامل نخاع (کلاس A در مقیاس ASIA)
دریافت رضایت آگاهانه
آسیب تروماتیک طناب نخاعی تا 636 ماه از مدت زمان آسیب آسیب کامل نخاع (کلاس A در مقیاس ASIA) دریافت رضایت آگاهانه
Health conditions studied
#1
Complete acute spinal cord injury
Complete spinal cord injury
Complete acute spinal cord injury
آسیب طناب نخاعی کامل و حاد
آسیب طناب نخاعی کامل
آسیب طناب نخاعی کامل و حاد
Intervention groups
#1
empty
Treatment - Other
treatment-other
empty
Intervention group: In this group, patients underwent standard spine decompression surgery in the injured area and stem cell exosomes were injected in each patient.
Intervention group: In this group, patients underwent standard spine decompression surgery in the injured area and stem cell exosomes were injected in each patient.
empty
گروه مداخله: در این گروه بیماران تحت عمل جراحی استاندارد دکمپرسیون ستون فقرات در ناحیه ی آسیب دیده شده و در تکای بیماران اگزوزوم های سلول های بنیادی تزریق شده.
گروه مداخله: در این گروه بیماران تحت عمل جراحی استاندارد دکمپرسیون ستون فقرات در ناحیه ی آسیب دیده شده و در تکای بیماران اگزوزوم های سلول های بنیادی تزریق شده.
Protocol summary
Study aim
Assessment of the combination of artificial dura and exosome in patients with complete spinal cord injury.
Design
This study is a non-randomized, controlled, four-arm parallel-group, phase 2 trial on 20 patients.
Settings and conduct
This study includes 20 patients having acute complete spinal cord injury. All the patients will be followed their standard spinal surgery in the hospital and assigned non-randomly in four groups to receive new treatments. Patients will be assessed in terms of the study outcomes before treatment, 3, 6, and 12 months after injury.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Traumatic spinal cord injury
36 months have passed since the spinal cord injury
Complete spinal cord injury (class A in ASIA scale)
Written informed consent
Exclusion criteria:
History of previous spinal surgery
Amputation
Having underlying diseases affecting the diagnosis and treatment process (such as diabetes mellitus, osteopenia, spinal cord injury, etc.)
Intervention groups
Patients in the present study will be non-randomly assigned to three groups including the patients treated with artificial dura and exosome group, the patients treated with artificial dura group, patients treated with exosome alone, and the control group which receives the standard therapy.
Main outcome variables
Primary outcomes: Sensory and motor scores of the American Spinal Injury Association Impairment Scale, mean of the Spinal Cord Independence Measure III scores of patients.
General information
Reason for update
According to the definition of the inclusion criteria, the patients who were initially included in the study had been up to six months since their injury, unfortunately, at the beginning of the study, only the word acute was written in the definitions of the protocol title, which has been corrected. On the other hand, to include patients with chronic phases, the time interval from the injury was changed to 36 months.
Due to the possible effects of exosome, we needed to add the exosome treatment group alone so that the clinical trial does not suffer from problems in terms of methodology and results, and the results of other groups can be compared with this group.
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047277N1
Registration date:2020-10-02, 1399/07/11
Registration timing:registered_while_recruiting
Last update:2023-01-28, 1401/11/08
Update count:2
Registration date
2020-10-02, 1399/07/11
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
2020-09-02, 1399/06/12
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and Efficacy Assessment of Combination of Artificial Dura and Exosome in Patients with Acute, Sub-acute and Chronic Complete Spinal Cord Injury: A Single-blinded Controlled Clinical Trial
Public title
Effect of the combination of artificial dura and exosome in patients with complete spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic spinal cord injury
Time from injury up to 36 months
Complete spinal cord injury (class A in ASIA scale)
Written informed consent
Exclusion criteria:
History of previous spinal surgery
Amputation
Having underlying diseases affecting the diagnosis and treatment process (such as: diabetes mellitus, osteopenia, spinal cord injury, etc.)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
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
2020-09-01, 1399/06/11
Ethics committee reference number
IR.SBMU.MSP.REC.1399.235
Health conditions studied
1
Description of health condition studied
Complete spinal cord injury
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Motor score of the American Spinal Injury Association Impairment Scale
Timepoint
Before treatment, 3, 6, and 12 months after injury.
Method of measurement
Physical examination
2
Description
Sensory score of the American Spinal Injury Association Impairment Scale
Timepoint
Before treatment, 3, 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, 3, 6, and 12 months after injury.
Method of measurement
Spinal Cord Independence Measure III questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients underwent spinal decompression surgery in the injured area and the patient's dura will be repaired by artificial dura made of polyethylene terephthalate then pre-prepared stem cell exosomes were injected in the injury area.
Category
Treatment - Other
2
Description
Intervention group: In this group, patients underwent spinal decompression surgery in the injured area and the patient's dura will be repaired by artificial dura made of polyethylene terephthalate.
Category
Treatment - Other
3
Description
Control group: In this group, patients underwent standard spinal decompression surgery in the injured area and standard physiotherapy will be prescribed for him.
Category
Treatment - Other
4
Description
Intervention group: In this group, patients underwent standard spine decompression surgery in the injured area and stem cell exosomes were injected in each patient.