The safety of placental mesenchymal stem cell therapy for the treatment of type 1 diabetes mellitus

phase I clinical trial placental mesenchymal stem cell therapy for the treatment of type 1 diabetes mellitus

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20171021036903N2

Enrollment

Registered

2019-12-24

Start date

2019-09-23

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

Diabetes Mellitus type 1. Type 1 diabetes mellitus without complications

Interventions

one time placental mesenchymal stem cell transplantation -which produced in endocrinology and metabolism research institute of Tehran university of medical science- from peripheral vein to T1Dm patien

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

Inclusion criteria: both gender 12-18 years old type one diabetes mellitus at least one positive auto antibody of T1DM in first 6 month of diagnosis

Exclusion criteria

Exclusion criteria: malignancy simultaneous auto immune disorders pregnancy chronic disorder other than diabetes

Design outcomes

Primary

Measure	Time frame
Daily insulin requirement. Timepoint: Before intervention and 1,3,6,12 month after intervention. Method of measurement: daily insulin requirement per kilogram weight.;HbA1c. Timepoint: Before and 1,3,6,12 month after intervention. Method of measurement: blood sample.;C peptide level. Timepoint: Before and 1,3,6,12 month after intervention. Method of measurement: blood sample.	—

Secondary

Measure	Time frame
Life threatening major side effect. Timepoint: before and 1,3,6 ,12 months after intervention. Method of measurement: physical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyedeh Sedigheh Madani

Tehran University of Medical Sciences

sedigheh_madani@yahoo.com+98 21 8863 1298

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 22, 2026