Safety of intradiscal injection of nucleus pulposus derived stromal cells in regeneration of human degenerated lumbar disc in patients with chronic low back pain
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Protocol summary
بررسی ایمنی واثر بخشی پیوند سلولهای مشتق از نوکلئوس پولپوزوس خودی در درمان دیسک بین مهره ای دژنره انسانی.
بررسی ایمنی و اثر بخشی پیوند سلولهای مشتق از نوکلئوس پولپوزوس خودی در درمان دیسک بین مهره ای دژنره انسانی.
بررسی ایمنی واثرو اثر بخشی پیوند سلولهای مشتق از نوکلئوس پولپوزوس خودی در درمان دیسک بین مهره ای دژنره انسانی.
Inclusion criteria:
Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months.
The fibrous ring is able to hold the injected cell based on the discography performed. This means that stage of the disease must be 2,3 or 4 and stage 5 cannot be included in the study. Reduction of the height of the intervertebral disc by 50% or more based on radiography.
Do not have a vertebral infection.
Exclusion criteria:
Symptoms of a local infection at the site of the spine or viral illnesses such as hepatitis and AIDS
Allergy to compounds such as bovine serum, gentamicin or horse serum
Localized spinal imbalance, spinal canal stenosis, ischemic pathology, or other conditions that may adversely affect the study.
Severe bone marrow changes due to intervertebral disc degeneration called Modic 3.
Neoplasia
Inclusion criteria:
Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months.
Confirmation of fibrous ring integrity for cell implantation by MRI
Reduction of the height of the intervertebral disc by 50% or more based on radiography.
Do not have a vertebral infection.
Exclusion criteria:
Symptoms of a local infection at the site of the spine or viral illnesses such as hepatitis and AIDS
Allergy to compounds such as bovine serum, gentamicin or horse serum
Localized spinal imbalance, spinal canal stenosis, ischemic pathology, or other conditions that may adversely affect the study.
Severe bone marrow changes due to intervertebral disc degeneration called Modic 3.
Neoplasia
Inclusion criteria: Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months. TheConfirmation of fibrous ring is able to hold the injectedintegrity for cell based on the discography performed. This means that stage of the disease must be 2,3 or 4 and stage 5 cannot be included in the study.implantation by MRI Reduction of the height of the intervertebral disc by 50% or more based on radiography. Do not have a vertebral infection. Exclusion criteria: Symptoms of a local infection at the site of the spine or viral illnesses such as hepatitis and AIDS Allergy to compounds such as bovine serum, gentamicin or horse serum Localized spinal imbalance, spinal canal stenosis, ischemic pathology, or other conditions that may adversely affect the study. Severe bone marrow changes due to intervertebral disc degeneration called Modic 3. Neoplasia
معیارهای ورود:
دیسک بین مهر ه ای دژنره در یک یا دو دیسک بین مهره ای لومبار با دردی که به درمانهای حمایتی قبلی شامل استفاده از مسکنهای رایج و یا درمانهای فیزیوتراپی در عرض 6 ماه اخیر پاسخ نداده باشد.
رینگ فیبروس بر اساس دیسکوگرافی انجام شده قادر به نگهداری سلول تزریق شده باشد. این بدان معناست که در مرحله بیماری باید 2،3 و یا 4 باشد و stage 5 قابل ورود به مطالعه نمی باشد کاهش ارتفاع 50 درصدی یا بیشتر دیسک بین مهره ای بر اساس رادیوگرافی انجام شده.
عفونت مهره ای نداشته باشد.
معیارهای خروج:
علایم عفونت موضعی در محل اسپاین و یا بیماریهای ویروسی نظیر هپاتیت و ایدز
آلرژی به ترکیباتی نظیر سرم گاوی، جنتامایسین و یا سرم اسبی
عدم تعادل اسپاین بصورت موضعی، تنگی کانال نخاعی، پاتولوژی ایسم و یا سایر شرایطی که منجر به تاثیر سوء بر مطالعه خواهند شد.
تغییرات شدید مغز استخوان ناشی از دژنراسیون دیسک بین مهره ای که تحت عنوان مودیک 3 نامیده می شوند.
نئوپلازی
معیارهای ورود:
دیسک بین مهر ه ای دژنره در یک یا دو دیسک بین مهره ای لومبار با دردی که به درمانهای حمایتی قبلی شامل استفاده از مسکنهای رایج و یا درمانهای فیزیوتراپی در عرض 6 ماه اخیر پاسخ نداده باشد.
تأیید یکپارچگی حلقه فیبری برای پیوند سلول توسط ام آر آی
کاهش ارتفاع 50 درصدی یا بیشتر دیسک بین مهره ای بر اساس رادیوگرافی انجام شده.
عفونت مهره ای نداشته باشد.
معیارهای خروج:
علایم عفونت موضعی در محل اسپاین و یا بیماریهای ویروسی نظیر هپاتیت و ایدز
آلرژی به ترکیباتی نظیر سرم گاوی، جنتامایسین و یا سرم اسبی
عدم تعادل اسپاین بصورت موضعی، تنگی کانال نخاعی، پاتولوژی ایسم و یا سایر شرایطی که منجر به تاثیر سوء بر مطالعه خواهند شد.
تغییرات شدید مغز استخوان ناشی از دژنراسیون دیسک بین مهره ای که تحت عنوان مودیک 3 نامیده می شوند.
نئوپلازی
معیارهای ورود: دیسک بین مهر ه ای دژنره در یک یا دو دیسک بین مهره ای لومبار با دردی که به درمانهای حمایتی قبلی شامل استفاده از مسکنهای رایج و یا درمانهای فیزیوتراپی در عرض 6 ماه اخیر پاسخ نداده باشد. رینگ فیبروس بر اساس دیسکوگرافی انجام شده قادر به نگهداریتأیید یکپارچگی حلقه فیبری برای پیوند سلول تزریق شده باشد. این بدان معناست که در مرحله بیماری باید 2،3 و یا 4 باشد و stage 5 قابل ورود به مطالعه نمی باشدتوسط ام آر آی کاهش ارتفاع 50 درصدی یا بیشتر دیسک بین مهره ای بر اساس رادیوگرافی انجام شده. عفونت مهره ای نداشته باشد. معیارهای خروج: علایم عفونت موضعی در محل اسپاین و یا بیماریهای ویروسی نظیر هپاتیت و ایدز آلرژی به ترکیباتی نظیر سرم گاوی، جنتامایسین و یا سرم اسبی عدم تعادل اسپاین بصورت موضعی، تنگی کانال نخاعی، پاتولوژی ایسم و یا سایر شرایطی که منجر به تاثیر سوء بر مطالعه خواهند شد. تغییرات شدید مغز استخوان ناشی از دژنراسیون دیسک بین مهره ای که تحت عنوان مودیک 3 نامیده می شوند. نئوپلازی
General information
empty
The assessment of annulus fibrosus (AF) integrity was based on MRI findings instead of discography.
This decision was made following the recommendation of expert clinicians at the Royan Institute, considering both the comprehensive diagnostic capability of MRI for disc evaluation and the ethical concerns associated with discography as an additional invasive procedure.
The assessment of annulus fibrosus (AF) integrity was based on MRI findings instead of discography. This decision was made following the recommendation of expert clinicians at the Royan Institute, considering both the comprehensive diagnostic capability of MRI for disc evaluation and the ethical concerns associated with discography as an additional invasive procedure.
empty
ارزیابی یکپارچگی حلقه فیبروزی (AF) به جای دیسکوگرافی، بر اساس یافتههای MRI انجام شد.
این تصمیم پس از توصیه پزشکان متخصص در پژوهشگاه رویان، با در نظر گرفتن قابلیت تشخیصی جامع MRI برای ارزیابی دیسک و نگرانیهای اخلاقی مرتبط با دیسکوگرافی به عنوان یک روش تهاجمی اضافی، اخذ شد.
ارزیابی یکپارچگی حلقه فیبروزی (AF) به جای دیسکوگرافی، بر اساس یافتههای MRI انجام شد. این تصمیم پس از توصیه پزشکان متخصص در پژوهشگاه رویان، با در نظر گرفتن قابلیت تشخیصی جامع MRI برای ارزیابی دیسک و نگرانیهای اخلاقی مرتبط با دیسکوگرافی به عنوان یک روش تهاجمی اضافی، اخذ شد.
Age between 18 and 65 years
Of both sexes
Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months.
The fibrous ring is able to hold the injected cell based on the discography performed. This means that stage of the disease must be 2,3 or 4 and stage 5 cannot be included in the study.
Reduction of intervertebral disc height by 50% or more based on radiography.
Do not have a vertebral infection.
Have no uncontrolled chronic underlying disease that is prohibited for treatment.
Have no uncontrolled chronic underlying disease that is prohibited for treatment.
Do not be pregnant or breastfeeding women.
Not positive and transmissible viral infection.
Age between 18 and 65 years
Of both sexes
Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months.
Confirmation of fibrous ring integrity for cell implantation by magnetic resonance imaging (MRI)
Reduction of intervertebral disc height by 50% or more based on radiography.
Do not have a vertebral infection.
Have no uncontrolled chronic underlying disease that is prohibited for treatment.
Have no uncontrolled chronic underlying disease that is prohibited for treatment.
Do not be pregnant or breastfeeding women.
Not positive and transmissible viral infection.
Age between 18 and 65 years Of both sexes Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months. TheConfirmation of fibrous ring is able to hold the injectedintegrity for cell based on the discography performed. This means that stage of the disease must be 2,3 or 4 and stage 5 cannot be included in the study.implantation by magnetic resonance imaging (MRI) Reduction of intervertebral disc height by 50% or more based on radiography. Do not have a vertebral infection. Have no uncontrolled chronic underlying disease that is prohibited for treatment. Have no uncontrolled chronic underlying disease that is prohibited for treatment. Do not be pregnant or breastfeeding women. Not positive and transmissible viral infection.
سن بین18 تا 65 سال
از هر دو جنس
دیسک بین مهر ه ای دژنره در یک یا دو دیسک بین مهره ای لومبار با دردی که به درمانهای حمایتی قبلی شامل استفاده از مسکنهای رایج و یا درمانهای فیزیوتراپی در عرض 6 ماه اخیر پاسخ نداده باشد.
رینگ فیبروس بر اساس دیسکوگرافی انجام شده قادر به نگهداری سلول تزریق شده باشد. این بدان معناست که stageبیماری باید 2،3 و یا 4 باشد و stage 5 قابل ورود به مطالعه نمی باشد.
کاهش ارتفاع 50 درصدی یا بیشتر دیسک بین مهره ای بر اساس رادیوگرافی انجام شده.
عفونت مهره ای نداشته باشد.
بیماری زمینه ای مزمن کنترل نشده ای که منعی برای درمان باشد نداشته باشد.
بیمار قادر به فهم ماهیت مطالعه و درک رضایتنامه باشد و ان را بصورت اگاهانه امضا کرده باشد.
خانمهای باردار و یا شیرده نباشند.
عفونت ویروسی مثبت و قابل انتقال نداشته باشد.
سن بین18 تا 65 سال
از هر دو جنس
دیسک بین مهر ه ای دژنره در یک یا دو دیسک بین مهره ای لومبار با دردی که به درمانهای حمایتی قبلی شامل استفاده از مسکنهای رایج و یا درمانهای فیزیوتراپی در عرض 6 ماه اخیر پاسخ نداده باشد.
تأیید یکپارچگی حلقه فیبری برای پیوند سلول با استفاده از ام آر آی
کاهش ارتفاع 50 درصدی یا بیشتر دیسک بین مهره ای بر اساس رادیوگرافی انجام شده.
عفونت مهره ای نداشته باشد.
بیماری زمینه ای مزمن کنترل نشده ای که منعی برای درمان باشد نداشته باشد.
بیمار قادر به فهم ماهیت مطالعه و درک رضایتنامه باشد و ان را بصورت اگاهانه امضا کرده باشد.
خانمهای باردار و یا شیرده نباشند.
عفونت ویروسی مثبت و قابل انتقال نداشته باشد.
سن بین18 تا 65 سال از هر دو جنس دیسک بین مهر ه ای دژنره در یک یا دو دیسک بین مهره ای لومبار با دردی که به درمانهای حمایتی قبلی شامل استفاده از مسکنهای رایج و یا درمانهای فیزیوتراپی در عرض 6 ماه اخیر پاسخ نداده باشد. رینگ فیبروس بر اساس دیسکوگرافی انجام شده قادر به نگهداریتأیید یکپارچگی حلقه فیبری برای پیوند سلول تزریق شده باشد. این بدان معناست که stageبیماری باید 2،3 و یا 4 باشد و stage 5 قابل ورود به مطالعه نمی باشد.با استفاده از ام آر آی کاهش ارتفاع 50 درصدی یا بیشتر دیسک بین مهره ای بر اساس رادیوگرافی انجام شده. عفونت مهره ای نداشته باشد. بیماری زمینه ای مزمن کنترل نشده ای که منعی برای درمان باشد نداشته باشد. بیمار قادر به فهم ماهیت مطالعه و درک رضایتنامه باشد و ان را بصورت اگاهانه امضا کرده باشد. خانمهای باردار و یا شیرده نباشند. عفونت ویروسی مثبت و قابل انتقال نداشته باشد.
Recruitment centers
#1
Name of recruitment center - English: Royan Cell Therapy Center
Name of recruitment center - Persian: مرکز سلول درمانی پژوهشگاه رویان
Full name of responsible person - English: Nasser Aghdami
Full name of responsible person - Persian: ناصر اقدمی
Street address - English: Tehran, Baharestan Square, Mojahedin-e-Islam St., Shafayehiaian Educational and Medical Center
Street address - Persian: تهران، ميدان بهارستان، خیابان مجاهدین اسلام، مرکز آموزشی و درمانی شفایحیائیان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 148- 16635
Phone: +98 21 3848 7000
Fax:
Email: Regmed.department@gmail.com
Web page address:
Name of recruitment center - English: Royan Cell Therapy Center
Name of recruitment center - Persian: مرکز سلول درمانی پژوهشگاه رویان
Full name of responsible person - English: Nasser Aghdami
Full name of responsible person - Persian: ناصر اقدمی
Street address - English: No. 9, Shaghayegh Alley, North Bani Hashem St., Shahid Soleimani Highway (Resalat), Tehran
Street address - Persian: تهران، بزرگراه شهید سلیمانی (رسالت)،نتهای خیابان بنیهاشم شمالی، کوچه شقایق، پلاک ۹
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1951883831
Phone: +98 21 2251 8388
Fax:
Email: Regmed.department@gmail.com
Web page address:
Name of recruitment center - English: Royan Cell Therapy Center Name of recruitment center - Persian: مرکز سلول درمانی پژوهشگاه رویان Full name of responsible person - English: Nasser Aghdami Full name of responsible person - Persian: ناصر اقدمی Street address - English: TehranNo. 9, Baharestan SquareShaghayegh Alley, Mojahedin-e-IslamNorth Bani Hashem St., Shafayehiaian Educational and Medical CenterShahid Soleimani Highway (Resalat), Tehran Street address - Persian: تهران، ميدان بهارستانبزرگراه شهید سلیمانی (رسالت)،نتهای خیابان مجاهدین اسلامبنیهاشم شمالی، مرکز آموزشی و درمانی شفایحیائیانکوچه شقایق، پلاک ۹ City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 148- 166351951883831 Phone: +98 21 3848 70002251 8388 Fax: Email: Regmed.department@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Royan Institute
Name of organization / entity - Persian: پژوهشگاه رویان
Full name of responsible person - English: Hamid Gourabi
Full name of responsible person - Persian: حمید گورابی
Street address - English: Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
Street address - Persian: 45 متری رسالت، خ بنی هاشم شمالی،خ حافظ شرقی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 148- 16635
Phone: +98 21 2356 2000
Fax:
Email: Regmed.department@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Royan Institute
Name of organization / entity - Persian: پژوهشگاه رویان
Full name of responsible person - English: Massoud Vosough
Full name of responsible person - Persian: مسعود وثوق
Street address - English: Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
Street address - Persian: 45 متری رسالت، خ بنی هاشم شمالی،خ حافظ شرقی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1951883831
Phone: +98 21 2251 8388
Fax:
Email: Regmed.department@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Royan Institute Name of organization / entity - Persian: پژوهشگاه رویان Full name of responsible person - English: Hamid GourabiMassoud Vosough Full name of responsible person - Persian: حمید گورابیمسعود وثوق Street address - English: Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway Street address - Persian: 45 متری رسالت، خ بنی هاشم شمالی،خ حافظ شرقی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 148- 166351951883831 Phone: +98 21 2356 20002251 8388 Fax: Email: Regmed.department@gmail.com Web page address:
Protocol summary
Study aim
Evaluation of safety and efficacy of Nucleus pulposus ion-derived cell transplantation in the treatment of human degenerative intervertebral disc.
Design
Phase 1 clinical trial on 5 patients who underwent transplantation of nucleus pulposus-derived cells in the degenerative disc.
Settings and conduct
Nucleus pulposus tissue of patient is removed during surgery in Noor orthopedic clinic and sent to Royan Institute clean room for extraction and cell culture and then in the second surgery it will be transplanted to patients' degenerative disc in Noor clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months.
Confirmation of fibrous ring integrity for cell implantation by MRI
Reduction of the height of the intervertebral disc by 50% or more based on radiography.
Do not have a vertebral infection.
Exclusion criteria:
Symptoms of a local infection at the site of the spine or viral illnesses such as hepatitis and AIDS
Allergy to compounds such as bovine serum, gentamicin or horse serum
Localized spinal imbalance, spinal canal stenosis, ischemic pathology, or other conditions that may adversely affect the study.
Severe bone marrow changes due to intervertebral disc degeneration called Modic 3.
Neoplasia
Intervention groups
A group receiving intradiscal transplantation of 20 million autologous nucleus pulposus-derived cells
Main outcome variables
Clinical examination, evaluation of complications of surgery or aspiration
General information
Reason for update
The assessment of annulus fibrosus (AF) integrity was based on MRI findings instead of discography.
This decision was made following the recommendation of expert clinicians at the Royan Institute, considering both the comprehensive diagnostic capability of MRI for disc evaluation and the ethical concerns associated with discography as an additional invasive procedure.
Acronym
IRCT registration information
IRCT registration number:IRCT20080728001031N35
Registration date:2022-10-08, 1401/07/16
Registration timing:retrospective
Last update:2025-07-15, 1404/04/24
Update count:1
Registration date
2022-10-08, 1401/07/16
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology
Expected recruitment start date
2017-12-25, 1396/10/04
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
2021-04-27, 1400/02/07
Actual recruitment end date
2021-07-23, 1400/05/01
Trial completion date
2022-08-22, 1401/05/31
Scientific title
Safety of intradiscal injection of nucleus pulposus derived stromal cells in regeneration of human degenerated lumbar disc in patients with chronic low back pain
Public title
Chronic low back pain nucleus pulposus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years
Of both sexes
Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months.
Confirmation of fibrous ring integrity for cell implantation by magnetic resonance imaging (MRI)
Reduction of intervertebral disc height by 50% or more based on radiography.
Do not have a vertebral infection.
Have no uncontrolled chronic underlying disease that is prohibited for treatment.
Have no uncontrolled chronic underlying disease that is prohibited for treatment.
Do not be pregnant or breastfeeding women.
Not positive and transmissible viral infection.
Exclusion criteria:
infection signs or positive serology for HIV, hepatitis and syphilis
allergy to gentanicin, or to bovine, cattle or horse serum
congenital or acquired disease leading to spine deformities that may upset cell application
spinal segmental instability, spinal canal stenos, isthmus pathology, and other conditions that may compromise the study
modic 3 changes on MRI images
overweight with body mass index greater than 30.5
neoplasia
immunosuppression
participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study
other conditions that may, according to medical criteria, discourage participation in the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
Actual sample size reached:
5
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 of Royan infertility institute
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Province
Tehran
Postal code
148- 16635
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.ACECR.ROYAN.REC.1394.36
Health conditions studied
1
Description of health condition studied
chronic low back pain
ICD-10 code
M51.1
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy
Primary outcomes
1
Description
Clinical examination
Timepoint
1- Within one month after discharge every week
Method of measurement
1- Within one month after discharge every week: Responsible: Specialist: Action plan: Clinical examination, examination of complications of surgery or aspiration
2
Description
evaluation of complications of surgery or aspiration
Timepoint
2-6 weeks after injection
Method of measurement
2-6 weeks after injection: Responsible: Specialist: Action plan: Clinical examination, examination of complications of operation or aspiration
Secondary outcomes
1
Description
Clinical examination and evaluation of the safety
Timepoint
Three months after injection
Method of measurement
Three months after injection: Responsible: Physician specializing in measures: Evaluation of treatment safety by evaluating questionnaires for examination of complications and clinical examinations
2
Description
blood and urine tests
Timepoint
6 months after injection
Method of measurement
six months after injection: Responsible: Physician specializing in measures blood and urine tests
3
Description
The effect of treatment by MRI
Timepoint
one year after injection
Method of measurement
one year after injection: Responsible: specialist doctor Measurs assessment of the effectiveness of treatment by MRI
Intervention groups
1
Description
Injection of stem cells derived from the intervertebral disc
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Cell Therapy Center
Full name of responsible person
Nasser Aghdami
Street address
No. 9, Shaghayegh Alley, North Bani Hashem St., Shahid Soleimani Highway (Resalat), Tehran
City
Tehran
Province
Tehran
Postal code
1951883831
Phone
+98 21 2251 8388
Email
Regmed.department@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Massoud Vosough
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Province
Tehran
Postal code
1951883831
Phone
+98 21 2251 8388
Email
Regmed.department@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
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
Royan Institute
Full name of responsible person
Massoud Vosough
Position
M.D/ Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Eastern Hafez St, Northern Banihashem St, 45 m Resalat highway
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2251 8388
Fax
Email
masvos@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Nasser Aghdami
Position
M.D/ Ph.D
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Province
Tehran
Postal code
1665664511
Phone
+98 21 2251 8388
Fax
Email
nasser.aghdami@royaninstitute.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Hoda Madani
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 9, Shaghayegh Alley, North Bani Hashem St., Shahid Soleimani Highway (Resalat), Tehran
City
Tehran
Province
Tehran
Postal code
1665664511
Phone
+98 21 2251 8388
Fax
Email
hoda62_m@yahoo.com
Web page address
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