Mesenchymal Stem Cells Transplantation in newly diagnosed Type-1 Diabetes Patients

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016070428786N1

Enrollment

Registered

2016-08-20

Start date

2015-12-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes. Insulin-dependent diabetes mellitus

Interventions

Intervention 1: 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. Intervention 2: Control: Receive placebo.

Treatment - Other

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

Control: Receive placebo

Eligibility

Sex/Gender

All

Age

8 Years to 40 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Safety. Timepoint: weeks 1,2,3, Months 1,2,3,6,9 & 12. Method of measurement: Assessment based on evaluater & subjects.	—

Secondary

Measure	Time frame
Hypoglycemic Unawareness episodes. Timepoint: weeks 1,2,3, Months 1,2,3,6,9 & 12. Method of measurement: Assessment based on evaluater & subjects.;Fasting C-peptide enhancement. Timepoint: weeks 1,2,3, Months 1,2,3,6,9 & 12. Method of measurement: Blood Test.;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.	—

Measure

Time frame

Hypoglycemic Unawareness episodes. Timepoint: weeks 1,2,3, Months 1,2,3,6,9 & 12. Method of measurement: Assessment based on evaluater & subjects.;Fasting C-peptide enhancement. Timepoint: weeks 1,2,3, Months 1,2,3,6,9 & 12. Method of measurement: Blood Test.;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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEnsiyeh Hajizadeh Saffar

Royan Institute

hajizadeh.ehs@gmail.com+98 21 2233 9949

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026