IRCT | Transplantation of allogenic mesenchymal stem cells (MSCs) derived from placenta and adipose tissue for the treatment of type 1 diabetes mellitus (T1DM): a clinical trial, phase 1 and 2.

Protocol summary

Study aim: To evaluate the safety and therapeutic effects of allogeneic MSCs transplantation (placenta and adipose tissue derived) in the treatment of T1DM.
Design: A double-blind randomized clinical trial with a parallel group design on 30 patients (10 patients in each group).
Settings and conduct: In this double-blind randomized clinical trial, 30 volunteer T1DM patients aged ≥18 from both sexes which diagnosed within 1 year will be recruited and randomly divided into three groups of control, Intervention group-1 and Intervention group-2 by sealedenvelope software. After injection of MSCs, all grouped are followed for 1 year.
Participants/Inclusion and exclusion criteria: Inclusion criteria: - All adults (≥ 18 year) with T1DM which diagnosis less than 1 year from the onset of diabetes - Have at least one T1DM related autoantibody Exclusion criteria: - Inability to fill informed consent - Pregnancy in women - Having any chronic complication of diabetes including nephropathy, retinopathy and vascular complications - Having a serious infection or have a positive test for hepatitis B, hepatitis C or HIV - Having other chronic comorbidities such as psychological, cardiovascular, renal, pulmonary, liver, hematologic and other serious autoimmune diseases (except T1DM or Hashimoto's disease) - History of cancer - History of diabetic ketoacidosis
Intervention groups: Intervention group-1: In this group, patients will be given allogeneic adipose tissue derived MSCs (single IV infusion of 1×10^6 cells/kg suspended in 100 mL of normal saline). Intervention group-2: In this group, patients will be given allogeneic placenta tissue derived MSCs (single IV infusion of 1×10^6 cells/kg suspended in 100 mL of normal saline). Control group: 100 mL of normal saline (single IV infusion).
Main outcome variables: Daily insulin requirement; HbA1c; Basal and stimulated C-peptide level; Side effects

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20210925052566N1

Registration date: 2022-01-23, 1400/11/03

Registration timing: prospective

Last update: 2022-01-23, 1400/11/03

Update count: 0
Registration date: 2022-01-23, 1400/11/03

Registrant information: Name

Sayed Mahmoud Sajjadi Jazi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 8822 0038

Email address

m_sajadi@tums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-05-22, 1401/03/01
Expected recruitment end date: 2023-05-22, 1402/03/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Transplantation of allogenic mesenchymal stem cells (MSCs) derived from placenta and adipose tissue for the treatment of type 1 diabetes mellitus (T1DM): a clinical trial, phase 1 and 2.

Public title: Transplantation of stem cells for the treatment of type 1 diabetes.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

All adults (≥ 18 year) with T1DM which diagnosis less than 1 year from the onset of diabetes Have at least one T1DM related autoantibody

Exclusion criteria:

Inability to fill informed consent Pregnancy in women Having any chronic complication of diabetes including nephropathy, retinopathy and vascular complications Having a serious infection or have a positive test for hepatitis B, hepatitis C or HIV Having other chronic comorbidities such as psychological, cardiovascular, renal, pulmonary, liver, hematologic and other serious autoimmune diseases (except T1DM or Hashimoto's disease) History of cancer History of diabetic ketoacidosis
Age: From 18 years old
Gender: Both

Phase

1-2

Groups that have been masked

Participant
Investigator

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

Randomization description

Block randomization method with block sizes of 3 will be use to randomize individuals using sealedenvelope online software (https://www.sealedenvelope.com/simple-randomiser/v1/lists). Allocation concealment will be carry out.

Blinding (investigator's opinion)

Double blinded

Blinding description

After randomization by sealedenvelope online software, the codes which generated by software are placed on stem cell or placebo bags by the stem cell production laboratory (stem cell and placebo bags are similar), both participants and researchers do not know the codes and are unaware of the study groups. The codes will be decrypted only after the end of the study or when serious complications occur.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Tehran University of Medical Sciences

Street address

Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.

City

Tehran

Province

Tehran

Postal code

1417653761
Approval date: 2021-09-15, 1400/06/24
Ethics committee reference number: IR.TUMS.MEDICINE.REC.1400.669

Health conditions studied

1

Description of health condition studied: Type 1 diabetes mellitus (T1DM)
ICD-10 code: E10
ICD-10 code description: Type 1 diabetes mellitus

Primary outcomes

1

Description: Daily insulin requirement
Timepoint: Before intervention and 1, 2, 3, 4, 8, 12, 24, 36, 48 weeks after intervention
Method of measurement: Total daily Insulin Requirement (in units of insulin)

2

Description: HbA1c
Timepoint: Before intervention and 1, 3, 6, 9, 12 month after intervention
Method of measurement: Blood sample

3

Description: Basal and stimulated C-peptide level
Timepoint: Before intervention and 1, 3, 6, 9, 12 month after intervention
Method of measurement: Blood sample

Secondary outcomes

1

Description: Side effects
Timepoint: Before intervention and 1, 2, 3, 4, 8, 12, 24, 36, 48 weeks after intervention
Method of measurement: History and physical examination

Intervention groups

1

Description: Intervention group-1: In this group, patients will be given allogeneic adipose tissue derived MSCs (single intravenous [IV] infusion of 1×10^6 cells/kg suspended in 100 mL of normal saline).
Category: Treatment - Drugs

2

Description: Intervention group-2: In this group, patients will be given allogeneic placenta tissue derived MSCs (single IV infusion of 1×10^6 cells/kg suspended in 100 mL of normal saline).
Category: Treatment - Drugs

3

Description: Control group: 100 mL of normal saline (single IV infusion).
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Dr. Shariati Hospital

Full name of responsible person

Sayed Mahmoud Sajjadi Jazi

Street address

Dr. Shariati Hospital, Jalal-AL-Ahmad Hwy., North Kargar St.

City

Tehran

Province

Tehran

Postal code

1411713135

Phone

+98 21 8822 0038

Email

m_sajadi@tums.ac.ir

2

Recruitment center: Name of recruitment center

Clinic of Diabetes and Metabolic Diseases

Full name of responsible person

Sayed Mahmoud Sajjadi Jazi

Street address

No. 33, Shahrivar St., North Kargar St.

City

Tehran

Province

Tehran

Postal code

1411716411

Phone

+98 21 8833 8740

Email

m_sajadi@tums.ac.ir

1

Sponsor: Name of organization / entity

Endocrinology and Metabolism Research Institute

Full name of responsible person

Dr. Bagher Larijani

Street address

No. 10, Next to Dr. Shariati Hospital, Jalal-AL-Ahmad Hwy.

City

Tehran

Province

Tehran

Postal code

1411713137

Phone

+98 21 8863 1296

Fax

+98 21 8822 0052

Email

emrc@tums.ac.ir

Web page address

http://emri.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Endocrinology and Metabolism Research 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

Tehran University of Medical Sciences

Full name of responsible person

Sayed Mahmoud Sajjadi Jazi

Position

Assistant professor

Latest degree

Subspecialist

Other areas of specialty/work

Endocrinology and Metabolism

Street address

Endocrinology and Metabolism Department, Dr. Shariati Hospital, Jalal-AL-Ahmad Hwy., North Kargar St.

City

Tehran

Province

Tehran

Postal code

1411713135

Phone

+98 21 8822 0038

Fax

+98 21 8822 0052

Email

m_sajadi@tums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Sayed Mahmoud Sajjadi Jazi

Position

Assistant professor

Latest degree

Subspecialist

Other areas of specialty/work

Endocrinology and Metabolism

Street address

Endocrinology and Metabolism Department, Dr. Shariati Hospital, Jalal-AL-Ahmad Hwy., North Kargar St.

City

Tehran

Province

Tehran

Postal code

1411713135

Phone

+98 21 8822 0038

Fax

+98 21 8822 0052

Email

m_sajadi@tums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Sayed Mahmoud Sajjadi Jazi

Position

Assistant professor

Latest degree

Subspecialist

Other areas of specialty/work

Endocrinology and Metabolism

Street address

Endocrinology and Metabolism Department, Dr. Shariati Hospital, Jalal-AL-Ahmad Hwy., North Kargar St.

City

Tehran

Province

Tehran

Postal code

1411713135

Phone

+98 21 8822 0038

Fax

+98 21 8822 0052

Email

m_sajadi@tums.ac.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: 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: 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: Not applicable
Title and more details about the data/document: All collected deidentified IPD
When the data will become available and for how long: Starting 6 months after publication
To whom data/document is available: Only available for people working in academic institutions
Under which criteria data/document could be used: The data can be analyzed after obtaining permission from the principal investigator
From where data/document is obtainable: Email to principal investigator m_sajadi@tums.ac.ir
What processes are involved for a request to access data/document: Email to primary investigator
Comments

Transplantation of allogenic mesenchymal stem cells (MSCs) derived from placenta and adipose tissue for the treatment of type 1 diabetes mellitus (T1DM): a clinical trial, phase 1 and 2.