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Investigation of the safety and efficacy of allogeneic mesenchymal stem cell transplantation derived from umbilical cord in patients with type 2 diabetes

Investigation of the safety and efficacy of allogeneic mesenchymal stem cell transplantation derived from umbilical cord in patients with type 2 diabetes: A before and after study.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130811014330N10
Enrollment
11
Registered
2024-11-11
Start date
2024-10-13
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Type 2 diabetes. Type 2 diabetes mellitus

Interventions

Intervention group: The administration of 1.5 x 10^6 mesenchymal stem cells derived from umbilical cord is to be conducted intravenously in three doses, spaced four weeks apart. (In the initial inject

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 35 kg/m2 = BMI = 24 kg/m2 10% = HbA1c= 8% The fasting C-peptide level is greater than or equal to 1 ng/mL. A stable dose of exogenous insulin between 0.5 and 1.5 U/kg/day for a minimum of 3 months prior to treatment. Not receiving biological drugs Patients who are receiving insulin analogs and have not been administered pioglitazone in the past three months.

Exclusion criteria

Exclusion criteria: Concurrent diagnosis of other chronic underlying diseases. Diabetic coma. Hyperosmolar syndrome. Renal failure with GFR < 60 ml/min. Myocardial or cerebral infarction within three months prior to treatment. Concurrent participation in other clinical trials. Failure to complete the informed consent form.

Design outcomes

Primary

MeasureTime frame
Investigating inflammatory factors. Timepoint: Six months after the intervention. Method of measurement: Gene expression levels measured by the real-time PCR method.

Secondary

MeasureTime frame
HbA1c level, the patient's need for insulin, blood glucose level, beta cell function (measured by the level of C-peptide), CBC? ESR. Timepoint: Six months after the intervention. Method of measurement: Biochemical and hematological laboratory tests.;Expression of inflammatory genes IKB-a, TNF-a, IL-6, and IL-1. Timepoint: Six months after the intervention. Method of measurement: Gene expression levels measured by the Real-time PCR method.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid reza Rahimi

Mashhad University of Medical Sciences

rahimihr@mums.ac.ir+98 51 3800 2301

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026