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Phase I Clinical Trial to Examine the Safety of Transplantation of Mesenchymal Stem Cells in New-onset Type 1 Diabetes Patients

Protocol summary

Summary
In this study, according to immunomodulatory role of mesenchymal stem cells and their role in increasing of regeneration, these cells are used to treat type-1 diabetes. Patients of both sexes in a range of 8 to 40 years old who have been diagnosed to have type-1 diabetes in no more than 6 weeks, antibody against beta cells diagnosed in their blood, fasting c-peptide more than or equal to 0.3 ng/ml, and are not suffered from other acute or chronic diseases and cancers, would be studied. In a double blinded randomized placebo-controlled phase I clinical trial, 20 patients with newly diagnosed type-1 diabetes who visited in Children’s Growth and Development Research Center of Tehran University of Medical Sciences and Royan Institute Cell Therapy Center, would be assessed through two groups including the case group (1 million autologous mesenchymal stem cells per kg of patient’s body weight in each dose, week 0 and 3) and the placebo group. Interventions: Intravascular transplantation of 1 million autologous mesenchymal stem cells per kg of patient’s body weight in each dose in week 0 and 3 in the case group & placebo injection in the control group. Outcome variables: safety of this treatment in weeks 1, 2, 3, Months 1, 2, 3, 6, 9 & 12 after first injection will be evaluated.

General information

Acronym
MSCTX-T1DM
IRCT registration information
IRCT registration number: IRCT2016070428786N1
Registration date: 2016-08-20, 1395/05/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-20, 1395/05/30
Registrant information
Name
Hossein Baharvand
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 6485
Email address
baharvand@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute
Expected recruitment start date
2015-12-23, 1394/10/02
Expected recruitment end date
2017-08-24, 1396/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phase I Clinical Trial to Examine the Safety of Transplantation of Mesenchymal Stem Cells in New-onset Type 1 Diabetes Patients
Public title
Mesenchymal Stem Cells Transplantation in newly diagnosed Type-1 Diabetes Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type 1 diabetes detection in less than 6 weeks; diabetes diagnosis according to American Diabetes Association; Presence of Antibodies against pancreatic beta cells; Both Sexes; Age: 8-40 years; Fasting C-peptide ≥ 0.3 ng/ml Exclusion Criteria: Pregnancy or breastfeeding; Cancer; Any acute or severe disease (According to physicians diagnosis: such as cardiac, pulmonary, hepatic, kidney, mental,… diseases); Positive results for: HIV, HTLV, HBV, HCV, CMV; Immune deficient or hyper aesthesia; History of ketoacidosis
Age
From 8 years old to 40 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Royan Institute
Street address
Hafez st.- Northern Banihashem Ave.- Resalat Exp. Way
City
Tehran
Postal code
19395-4644
Approval date
2015-12-08, 1394/09/17
Ethics committee reference number
IR.ACECR.ROYAN.REC.1394.50

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Safety
Timepoint
weeks 1,2,3, Months 1,2,3,6,9 & 12
Method of measurement
Assessment based on evaluater & subjects

Secondary outcomes

1

Description
Hypoglycemic Unawareness episodes
Timepoint
weeks 1,2,3, Months 1,2,3,6,9 & 12
Method of measurement
Assessment based on evaluater & subjects

2

Description
fasting C-peptide enhancement
Timepoint
weeks 1,2,3, Months 1,2,3,6,9 & 12
Method of measurement
Blood Test

3

Description
Patient's Metabolic indexes enhancement
Timepoint
weeks 1,2,3, Months 1,2,3,6,9 & 12
Method of measurement
Assessing HbA1C, C-peptide & Insulin demand of patients

Intervention groups

1

Description
Case group: Intravenous injection of 1 million autologous mesenchymal stem cells per kg of patient’s body weight in each dose, week 0 and 3
Category
Treatment - Other

2

Description
Control: Receive placebo
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Ensiyeh Hajizadeh Saffar
Street address
Hafez st.- Northern Banihashem Ave.- Resalat Exp. Way
City
Tehran

2

Recruitment center
Name of recruitment center
Children's Growth and Development Research Center
Full name of responsible person
Ali Rabani
Street address
Children's Medical Center- Dr Gharib St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Hamid Gourabi
Street address
Hafez st.- Northern Banihashem Ave.- Resalat Exp. Way
City
Tehran
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Ensiyeh Hajizadeh Saffar
Position
MD\PhD in Medical Biotechnology
Other areas of specialty/work
Street address
Hafez st.- Northern Banihashem Ave.- Resalat Exp. Way
City
Tehran
Postal code
16635-148
Phone
+98 21 2233 9949
Fax
Email
hajizadeh.ehs@gmail.com
Web page address
www.royaninstitute.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Hossein Baharvand
Position
PhD in Developmental Biology
Other areas of specialty/work
Street address
Royan Institute for Stem cells Biology and Technology- Royan Institute- Hafez St.- Northern Banihashem Ave.- Resalat Exp Way
City
Tehran
Postal code
16635-148
Phone
+98 21 2230 6485
Fax
+98 21 2356 2507
Email
baharvand@royaninstitute.org
Web page address
www.royaninstitute.org

Person responsible for updating data

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Mahmoud Izadi
Position
MSc in Medical Biotehnology
Other areas of specialty/work
Street address
3rd floor- Royan Institute Cell Therapy Center- No. 9- Shaghayegh Dead end- Northern Banihashem Avenue- Resalat Exp. Way
City
Tehran
Postal code
16635-148
Phone
+98 21 2231 0368
Fax
+98 21 8879 3329
Email
ma14i@yahoo.com
Web page address
www.royaninstitute.org

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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