Safety and Efficacy Assessment of Combination of Artificial Dura and Umbilical Cord and Placenta Mesenchymal Stem Cell-Derived Exosomes 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 complete spinal cord injury.
Assessment of the combination of artificial dura and umbilical cord and placenta-derived mesenchymal stem cell exosomes in patients with complete spinal cord injury.
Assessment of the combination of artificial dura and exosomeumbilical cord and placenta-derived mesenchymal stem cell exosomes in patients with complete spinal cord injury.
ارزیابی ترکیب دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب کامل نخاع.
ارزیابی ترکیب دورای مصنوعی و اگزوزوم مشتق از سلول های بنیادی مزانشیمال بند ناف و جفت در بیماران مبتلا به آسیب کامل نخاع.
ارزیابی ترکیب دورای مصنوعی و اگزوزوم مشتق از سلول های بنیادی مزانشیمال بند ناف و جفت در بیماران مبتلا به آسیب کامل نخاع.
General information
20
60
2060
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. The source of the exosomes was added and the study population edited.
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. The source of the exosomes was added and the study population edited.
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. منبع اگزوزوم ها اضافه گردید و تعداد بیماران تصحیح شد.
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. منبع اگزوزوم ها اضافه گردید و تعداد بیماران تصحیح شد.
Effect of the combination of artificial dura and exosome in patients with complete spinal cord injury
Effect of the combination of artificial dura and umbilical cord and placenta mesenchymal stem cell-derived exosomes in patients with complete spinal cord injury
Effect of the combination of artificial dura and exosomeumbilical cord and placenta mesenchymal stem cell-derived exosomes in patients with complete spinal cord injury
اثر ترکیبی دورای مصنوعی و اگزوزوم در بیماران مبتلا به آسیب کامل نخاع
اثر ترکیبی دورای مصنوعی و اگزوزوم های مشتق از سلول های بنیادی مزانشیمی بند ناف و جفت در بیماران مبتلا به آسیب کامل نخاع
اثر ترکیبی دورای مصنوعی و اگزوزوم های مشتق از سلول های بنیادی مزانشیمی بند ناف و جفت در بیماران مبتلا به آسیب کامل نخاع
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 Umbilical Cord and Placenta Mesenchymal Stem Cell-Derived Exosomes 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 ExosomeUmbilical Cord and Placenta Mesenchymal Stem Cell-Derived Exosomes 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، تحت حاد و مزمن کامل نخاع: یک کارآزمایی بالینی کنترل شده تک سو کور
ارزیابی ایمنی و کارآیی ترکیبی دورای مصنوعی و اگزوزوم های مشتق از سلول های بنیادی مزانشیمی بند ناف و جفت از بند 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 های مشتق از سلول های بنیادی مزانشیمی بند ناف و جفت از بند در بیماران مبتلا به آسیب حاد، تحت حاد و مزمن کامل نخاع: یک کارآزمایی بالینی کنترل شده تک سو کور
Intervention groups
#1
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.
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 umbilical cord and placenta-derived mesenchymal stem cell exosomes were injected in the injury area.
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 umbilical cord and placenta-derived mesenchymal stem cell exosomes were injected in the injury area.
گروه مداخله: در این گروه بیماران تحت عمل جراحی دکمپرسیون ستون فقرات در ناحیه ی آسیب دیده شده و دورای این بیماران توسط دورای مصنوعی از جنس پلي اتیلن ترفتاالت ترمیم می شود سپس اگزوزوم های سلول های بنیادی که از قبل آماده شده اند در ناحیه ی آسیب تزریق شده.
گروه مداخله: در این گروه بیماران تحت عمل جراحی دکمپرسیون ستون فقرات در ناحیه ی آسیب دیده شده و دورای این بیماران توسط دورای مصنوعی از جنس پلي اتیلن ترفتاالت ترمیم می شود سپس اگزوزوم های سلول های بنیادی مزانشیمال مشتق از بند ناف و جفت که از قبل آماده شده اند در ناحیه ی آسیب تزریق شده.
گروه مداخله: در این گروه بیماران تحت عمل جراحی دکمپرسیون ستون فقرات در ناحیه ی آسیب دیده شده و دورای این بیماران توسط دورای مصنوعی از جنس پلي اتیلن ترفتاالت ترمیم می شود سپس اگزوزوم های سلول های بنیادی مزانشیمال مشتق از بند ناف و جفت که از قبل آماده شده اند در ناحیه ی آسیب تزریق شده.
#2
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 umbilical cord and placenta-derived mesenchymal stem cell exosomes were injected in each patient.
Intervention group: In this group, patients underwent standard spine decompression surgery in the injured area, and umbilical cord and placenta-derived mesenchymal stem cell exosomes were injected in each patient.
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 گزوزوم های سلول های بنیادی مزانشیمال مشتق از بند ناف و جفت 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 اگزوزومگزوزوم های سلول های بنیادی مزانشیمال مشتق از بند ناف و جفت تزریق شده.
Protocol summary
Study aim
Assessment of the combination of artificial dura and umbilical cord and placenta-derived mesenchymal stem cell exosomes 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. The source of the exosomes was added and the study population edited.
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047277N1
Registration date:2020-10-02, 1399/07/11
Registration timing:registered_while_recruiting
Last update:2023-03-25, 1402/01/05
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 Umbilical Cord and Placenta Mesenchymal Stem Cell-Derived Exosomes 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 umbilical cord and placenta mesenchymal stem cell-derived exosomes 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:
60
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 umbilical cord and placenta-derived mesenchymal 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 umbilical cord and placenta-derived mesenchymal stem cell exosomes were injected in each patient.