Evaluation of Safety and Effectiveness of Expanded Allogenic Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer (Phase I/II Clinical Trail)
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Evaluation of Safety and Effectivness of Expanded Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer
Evaluation of Safety and Effectivness of Expanded Allogenic Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer
Evaluation of Safety and Effectivness of Expanded Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer
تعیین ایمنی (Safety) و اثربخشی (Efficacy) استفاده از سلولهای بنیادی آلوژنیک تکثیریافته مشتق شده از بافت چربی در درمان زخم مزمن پای دیابتی نوروپاتیک
تعیین ایمنی (Safety) و اثربخشی (Efficacy) استفاده از سلولهای بنیادی آلوژنیک تکثیریافته در درمان زخم مزمن پای دیابتی نوروپاتیک
تعیین ایمنی (Safety) و اثربخشی (Efficacy) استفاده از سلولهای بنیادی آلوژنیک تکثیریافته مشتق شده از بافت چربی در درمان زخم مزمن پای دیابتی نوروپاتیک
In this study, 20 volunteers with Wagner Grade 2 diabetic foot ulcer will be recruited. This study will be a phase I and II clinical trial that the patients after standard treatment (debridement, infection control and off-loading) will be undergone adipose drived mesenchymal stem cell injection. The investigators will follow the patients for weekly up to first months, biweekly up to third months and monthly up to six months. The outcomes will be local and systemic reactions, wound area changes, and frequency of complete healing during study period.
In this study, 20 volunteers with Wagner Grade 2 diabetic foot ulcer will be recruited. This study will be a phase I and II clinical trial that the patients after standard treatment (debridement, infection control and off-loading) will be undergone Menstrual blood drived mesenchymal stem cell injection. The investigators will follow the patients for weekly up to first months, biweekly up to third months and monthly up to six months. The outcomes will be local and systemic reactions, wound area changes, and frequency of complete healing during study period.
In this study, 20 volunteers with Wagner Grade 2 diabetic foot ulcer will be recruited. This study will be a phase I and II clinical trial that the patients after standard treatment (debridement, infection control and off-loading) will be undergone adiposeMenstrual blood drived mesenchymal stem cell injection. The investigators will follow the patients for weekly up to first months, biweekly up to third months and monthly up to six months. The outcomes will be local and systemic reactions, wound area changes, and frequency of complete healing during study period.
در این مطالعه تعداد 20 داوطلب مبتلا به زخم مزمن پای دیابتی درجه 2 وگنر مورد بررسی قرار می گیرند. نوع مطالعه یک کارآزمایی بالینی فاز یک و دو می باشد و بیماران پس از درمان استاندارد ((شامل دبریدمان جراحی، کنترل عفونت و حذف فشار) تحت درمان پیوند سلولهای بنیادی مزانشمی مشتق شده از بافت چربی طی یک جلسه قرار می گیرند. بیماران در ماه اول، هر هفته و سپس در ماه دوم و سوم هر دو هفته و سپس تا ماه ششم هر ماه یک بار مورد ارزیابی قرار می گیرند. پیامدهای مطالعه شامل واکنشهای پوستی و حساسیتی موضعی و سیستمیک به همراه نغییرات سطح زخم و فراوانی بهبودی کامل طی مدت پیگیری می باشد.
در این مطالعه تعداد 20 داوطلب مبتلا به زخم مزمن پای دیابتی درجه 2 وگنر مورد بررسی قرار می گیرند. نوع مطالعه یک کارآزمایی بالینی فاز یک و دو می باشد و بیماران پس از درمان استاندارد ((شامل دبریدمان جراحی، کنترل عفونت و حذف فشار) تحت درمان پیوند سلولهای بنیادی مزانشمی خون قاعدگی طی یک جلسه قرار می گیرند. بیماران در ماه اول، هر هفته و سپس در ماه دوم و سوم هر دو هفته و سپس تا ماه ششم هر ماه یک بار مورد ارزیابی قرار می گیرند. پیامدهای مطالعه شامل واکنشهای پوستی و حساسیتی موضعی و سیستمیک به همراه نغییرات سطح زخم و فراوانی بهبودی کامل طی مدت پیگیری می باشد.
در این مطالعه تعداد 20 داوطلب مبتلا به زخم مزمن پای دیابتی درجه 2 وگنر مورد بررسی قرار می گیرند. نوع مطالعه یک کارآزمایی بالینی فاز یک و دو می باشد و بیماران پس از درمان استاندارد ((شامل دبریدمان جراحی، کنترل عفونت و حذف فشار) تحت درمان پیوند سلولهای بنیادی مزانشمی مشتق شده از بافت چربیخون قاعدگی طی یک جلسه قرار می گیرند. بیماران در ماه اول، هر هفته و سپس در ماه دوم و سوم هر دو هفته و سپس تا ماه ششم هر ماه یک بار مورد ارزیابی قرار می گیرند. پیامدهای مطالعه شامل واکنشهای پوستی و حساسیتی موضعی و سیستمیک به همراه نغییرات سطح زخم و فراوانی بهبودی کامل طی مدت پیگیری می باشد.
Intervention group is the injection of adipose drived mesenchymal stem cells in one session.
Intervention group is the injection of allogenic mesenchymal stem cells in one session.
Intervention group is the injection of adipose drivedallogenic mesenchymal stem cells in one session.
گروه مداخله شامل تزریق موضعی سلولهای بنیادی مزانشمی مشتق شده از بافت چربی در یک جلسه می باشد.
گروه مداخله شامل تزریق موضعی سلولهای بنیادی مزانشمی آلوژنیک در یک جلسه می باشد.
گروه مداخله شامل تزریق موضعی سلولهای بنیادی مزانشمی مشتق شده از بافت چربیآلوژنیک در یک جلسه می باشد.
General information
2018-01-21, 1396/11/01
2019-03-21, 1398/01/01
20182019-0103-21 00:00:00
2018-06-22, 1397/04/01
2020-08-22, 1399/06/01
20182020-0608-22 00:00:00
empty
Due to the limitation of achieving healthy volunteers donating adipose tissue and the lack of GMP standardization by the clean room of Helal Medical Complex, the source of mesenchymal stem cells (MSCs) was changed to the commercial MSCs product (SinaBioMBcells) ontained from Avecina Institute.
Due to the limitation of achieving healthy volunteers donating adipose tissue and the lack of GMP standardization by the clean room of Helal Medical Complex, the source of mesenchymal stem cells (MSCs) was changed to the commercial MSCs product (SinaBioMBcells) ontained from Avecina Institute.
empty
با توجه به عدم امکان دستیابی به داوطلبین سالم اهدا کننده بافت چربی و عدم احراز استاندارد GMP توسط اتاق تمیز مجتمع درمانی هلال، منیع سلولهای بنیادی مزانشیمی به رده سلولی SinaBioMBcell تجاری از پژوهشگاه ابن سینا تغییر کرد.
با توجه به عدم امکان دستیابی به داوطلبین سالم اهدا کننده بافت چربی و عدم احراز استاندارد GMP توسط اتاق تمیز مجتمع درمانی هلال، منیع سلولهای بنیادی مزانشیمی به رده سلولی SinaBioMBcell تجاری از پژوهشگاه ابن سینا تغییر کرد.
Evaluation of Safety and Effectiveness of Expanded Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer (Phase I/II Clinical Trail)
Evaluation of Safety and Effectiveness of Expanded Allogenic Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer (Phase I/II Clinical Trail)
Evaluation of Safety and Effectiveness of Expanded Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer (Phase I/II Clinical Trail)
بررسی ایمنی و اثربخشی استفاده از سلولهای بنیادی مزانشیمی آلوژنیک تکثیر شده مشتق از بافت چربی در درمان زخم مزمن پای دیابتی نوروپاتیک (فاز یک و دو کارآزمایی بالینی)
بررسی ایمنی و اثربخشی استفاده از سلولهای بنیادی مزانشیمی آلوژنیک در درمان زخم مزمن پای دیابتی نوروپاتیک (فاز یک و دو کارآزمایی بالینی)
بررسی ایمنی و اثربخشی استفاده از سلولهای بنیادی مزانشیمی آلوژنیک تکثیر شده مشتق از بافت چربی در درمان زخم مزمن پای دیابتی نوروپاتیک (فاز یک و دو کارآزمایی بالینی)
empty
empty
empty
empty
Intervention groups
#1
Intervention group: the volunteers who will receive adipose drived mesenchymal stem cells in one session.
Intervention group: the volunteers who will receive allogenic mesenchymal stem cells in one session.
Intervention group: the volunteers who will receive adipose drivedallogenic mesenchymal stem cells in one session.
گروه مداخله: شامل داوطلبینی است که سلولهای بنیادی مزانشمی مشتق شده از بافت چربی به صورت موضعی در یک جلسه دریافت می دارند.
گروه مداخله: شامل داوطلبینی است که سلولهای بنیادی مزانشمی آلوژنیک به صورت موضعی در یک جلسه دریافت می دارند.
گروه مداخله: شامل داوطلبینی است که سلولهای بنیادی مزانشمی مشتق شده از بافت چربیآلوژنیک به صورت موضعی در یک جلسه دریافت می دارند.
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Helal Iran Pharmaceutic and Clinical Complex
Name of organization / entity - Persian: مجتمع دارویی درمانی هلال ایران
Full name of responsible person - English: Hamidreza Chobineh
Full name of responsible person - Persian: حمید رضا چوبینه
Street address - English: Tehranparsو Jashnvareh streetو Seyed Shohada
Street address - Persian: خیابان تهرانپارس - خیابان جشنواره - بعد از چهارراه سید الشهدا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1234567891
Phone: +98 21 7733 6006
Fax: +98 21 7733 6006
Email: hchobineh@tums.ac.ir
Web page address: http://www.helalclinic.com/
contact.organization_id:
Name of organization / entity - English: Avecinna Research Insititue
Name of organization / entity - Persian: پژوهشگاه فناوری های نوین علوم زیستی جهاد دانشگاهی - ابن سینا
Full name of responsible person - English: Somayeh Kazemnejad
Full name of responsible person - Persian: سمیه کاظم نژاد
Street address - English: Avecinna Institute, Shahid Beheshti University,
Street address - Persian: دانشگاه شهید بهشتی، پژوهشگاه ابن سینا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1936773493
Phone: +98 21 2243 2020
Fax: +98 21 2243 2021
Email: s.kazemnejad@ari.ir
Web page address: https://www.avicenna.ac.ir/
contact.organization_id: Name of organization / entity - English: Helal Iran Pharmaceutic and Clinical ComplexAvecinna Research Insititue Name of organization / entity - Persian: مجتمع دارویی درمانی هلال ایرانپژوهشگاه فناوری های نوین علوم زیستی جهاد دانشگاهی - ابن سینا Full name of responsible person - English: Hamidreza ChobinehSomayeh Kazemnejad Full name of responsible person - Persian: حمید رضا چوبینهسمیه کاظم نژاد Street address - English: Tehranparsو Jashnvareh streetو Seyed ShohadaAvecinna Institute, Shahid Beheshti University, Street address - Persian: خیابان تهرانپارس - خیابان جشنواره - بعد از چهارراه سید الشهدادانشگاه شهید بهشتی، پژوهشگاه ابن سینا City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 12345678911936773493 Phone: +98 21 7733 60062243 2020 Fax: +98 21 7733 60062243 2021 Email: hchobinehs.kazemnejad@tums.ac.irari.ir Web page address: httphttps://www.helalclinic.comwww.avicenna.ac.ir/
Yes
empty
1
38
100
38100
Private
Public
privatepublic
Other
Academic
otheracademic
Helal Iran Pharmaceutic and Clinical Complex
Academic Center for Education, Culture and Research (ACECR)
Helal Iran PharmaceuticAcademic Center for Education, Culture and Clinical ComplexResearch (ACECR)
مجتمع دارویی درمانی هلال ایران
جهاد دانشگاهی
مجتمع دارویی درمانی هلال ایرانجهاد دانشگاهی
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zahra Torabi Nasaj
Full name of responsible person - Persian: زهرا ترابی نساج
Position - English: Adiminstration
Position - Persian: کارشناس/مدارک پزشکی
Latest degree: bachelor
Area of specialty/work: 9
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 66 Abourihan Street
Street address - Persian: خیابان ابوریحان، پلاک 66
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1315673951
Phone: +98 21 6698 9110
Mobile: +98 912 890 7660
Fax: +98 21 6640 4720
Email: hosna_nassaj@yahoo.com
Web page address: http://jdtums.ir/
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mehrangiz Toutounchi
Full name of responsible person - Persian: مهرانگیز توتونچی
Position - English: Physician
Position - Persian: پزشک
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 66 Abourihan Street
Street address - Persian: خیابان ابوریحان، پلاک 66
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1315673951
Phone: +98 21 6698 9110
Mobile: +98 912 239 0644
Fax: +98 21 6640 4720
Email: hosna_nassaj@yahoo.com
Web page address: http://jdtums.ir/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Zahra Torabi NasajMehrangiz Toutounchi Full name of responsible person - Persian: زهرا ترابی نساجمهرانگیز توتونچی Position - English: AdiminstrationPhysician Position - Persian: کارشناس/مدارک پزشکیپزشک Latest degree: bachelormed_doctor Area of specialty/work: 930 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 66 Abourihan Street Street address - Persian: خیابان ابوریحان، پلاک 66 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1315673951 Phone: +98 21 6698 9110 Mobile: +98 912 890 7660239 0644 Fax: +98 21 6640 4720 Email: hosna_nassaj@yahoo.com Web page address: http://jdtums.ir/
Protocol summary
Study aim
Evaluation of Safety and Effectivness of Expanded Allogenic Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer
Design
In this study, 20 volunteers with Wagner Grade 2 diabetic foot ulcer will be recruited. This study will be a phase I and II clinical trial that the patients after standard treatment (debridement, infection control and off-loading) will be undergone Menstrual blood drived mesenchymal stem cell injection. The investigators will follow the patients for weekly up to first months, biweekly up to third months and monthly up to six months. The outcomes will be local and systemic reactions, wound area changes, and frequency of complete healing during study period.
Settings and conduct
This study will be conducted at Wound Healing Center of ACECR as a Phase I and II clinical trial in the volunteers with neuropatic diabetic foot wound.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: volunteers with chronic neuropathic diabetic foot ulcer (more than 6 weeks) with wound classification Wagner II, Suitable tissue perfusion (ABI>0.8) and full informed consent for recruitment in the study. Exclusion Criteria: Suspected osteomyelitis, using corticosteroid or immuno-suppressor drug, chronic renal failure of hemodialysis, and charco Joint.
Intervention groups
Intervention group is the injection of allogenic mesenchymal stem cells in one session.
Main outcome variables
1) Local and systemic side effects
2) complete healing rate
General information
Reason for update
Due to the limitation of achieving healthy volunteers donating adipose tissue and the lack of GMP standardization by the clean room of Helal Medical Complex, the source of mesenchymal stem cells (MSCs) was changed to the commercial MSCs product (SinaBioMBcells) ontained from Avecina Institute.
Acronym
IRCT registration information
IRCT registration number:IRCT20170612034485N2
Registration date:2018-02-11, 1396/11/22
Registration timing:prospective
Last update:2020-05-23, 1399/03/03
Update count:1
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Gholamreza Esmaeeli Djavid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6698 9110
Email address
djavid@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Safety and Effectiveness of Expanded Allogenic Mesenchymal Stem Cells for the Treatment of Neuropatic Diabetic Foot Ulcer (Phase I/II Clinical Trail)
Public title
Allogenic stem cell in diabetic wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic neuropathic diabetic foot ulcer (more than 6 weeks) with wound classification Wagner II
full informed consent for recruitment in the study
Suitable tissue perfusion (ABI>0.8) and normal flow of main arteries in lower extremities
Exclusion criteria:
Suspected osteomyelitis
Using corticosteroid or immuno-suppressor drug
Chronic renal failure of Hemodialysis
Charco Joint
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Biomedical Research Ethics Committeeَ of Academic Center for Education, Culture and Research (ACECR)
Street address
ACECR Central Office, No. 1270 Enqelab Avenue
City
Tehran
Province
Tehran
Postal code
4364 - 14155
Approval date
2018-01-07, 1396/10/17
Ethics committee reference number
IR.ACECR.REC.1396.2
Health conditions studied
1
Description of health condition studied
Chronic diabetic foot Ulcer
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer
Primary outcomes
1
Description
Local and systemic side-effects
Timepoint
Every month up to month 6th
Method of measurement
Clinical examination
2
Description
Complete wound healing during study (at least 6 months)
Timepoint
Every month up to month 6th
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the volunteers who will receive allogenic mesenchymal stem cells in one session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ٌWound Healing Center, ACECR of Tehran University of Medical Sciences Branch
Full name of responsible person
Gholamreza Esmaeeli Djavid
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6648 8973
Email
djavid@ut.ac.ir
Web page address
http://jdtums.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Seyed Mehdi Tabaie
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6640 4720
Fax
+98 21 6640 4720
Email
smtabaie@yahoo.com
Web page address
http://jdtums.ir/
Grant name
Official Center of ACECR
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
68
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
2
Sponsor
Name of organization / entity
Avecinna Research Insititue
Full name of responsible person
Somayeh Kazemnejad
Street address
Avecinna Institute, Shahid Beheshti University,
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Fax
+98 21 2243 2021
Email
s.kazemnejad@ari.ir
Web page address
https://www.avicenna.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Academic Center for Education, Culture and Research (ACECR)
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
Iranian academic center for education culture and research
Full name of responsible person
Gholamreza Esmaeeli Djavid
Position
MD-PhD/ Director
Latest degree
Ph.D.
Other areas of specialty/work
Biophysics
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6698 9110
Email
djavid@ut.ac.ir
Web page address
http://jdtums.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Seyed Mehdi Tabaie
Position
Head of TUMS Branch of ACECR
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6640 4720
Fax
+98 21 6640 4720
Email
smtabaie@yahoo.com
Web page address
http://jdtums.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Mehrangiz Toutounchi
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 66 Abourihan Street
City
Tehran
Province
Tehran
Postal code
1315673951
Phone
+98 21 6698 9110
Fax
+98 21 6640 4720
Email
hosna_nassaj@yahoo.com
Web page address
http://jdtums.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All NA data will be accessible after publication.
When the data will become available and for how long
Time duration for access to the data will begin after publication for 2 years.
To whom data/document is available
Academic faculty member
Under which criteria data/document could be used
Systematic review and meta-analysis
From where data/document is obtainable
Contact with scientific correspondence of the project
What processes are involved for a request to access data/document