Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646724

Enrollment

Registered

2008-03-28

Start date

2008-01-31

Completion date

2014-01-31

Last updated

2011-06-16

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

Conditions

Type 1 Diabetes Mellitus

Keywords

Islets of Langerhans Transplantation, Mesenchymal Stem Cells, Type 1 Diabetes Mellitus

Brief summary

The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation through the following mechanisms: protection of islet from inflammatory damage, immunological modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin and improve β-cell function.

Interventions

BIOLOGICALcotransplantation of islet and mesenchymal stem cell

islet of allograft and MSCs of autograft

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Male and female patients age 18 to 60 years of age * Ability to provide written informed consent * Manifest signs and symptoms that are severe enough to be incapacitating * Patients with poor diabetes control (HbA1c \> 7% but \< 12%) * Progressive diabetic complications

Exclusion criteria

* age \< 18 years or \> 60 years * diabetic history \< 5 years * BMI \> 27 * body weight \> 80 kg * exogenous insulin requirement \> 1 unit/kg/day * severe anemia (male \< 8 g/dl, female \< 7 g/dl) * low white blood cell count (\< 3000/dl) * liver dysfunction * Active infection including hepatitis B, hepatitis C, HIV, or TB * panel reactive antibody \> 20% * Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial

Design outcomes

Primary

Measure	Time frame
Exogenous insulin requirement	5
Hemoglobin A1c	5
Glucose and C-peptide levels	5

Secondary

Measure	Time frame
autoantibodies	5
liver function	5
Complete Blood Count	5
kidney function	5
Portal vein Ultrasound	1

Countries

China

Contacts

Primary ContactJianming Tan, Professor

TANJM156@YAHOO.COM.CN008613375918000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026