Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes

Lu Debin

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Evidence of Liver Transplantation

Treatments: Biological: Autologous transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01157403

ldb201001

Details and patient eligibility

About

Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for T1DM,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. Therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.

Full description

Autologous transplantation of Bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously

Enrollment: 80 estimated patients

Sex: All

Ages: 10 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ability to provide written informed consent from patients or Child guardian
2. Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks •

Exclusion criteria

1. Body Mass Index >30
2. Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
3. Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
4. Infectious diseases, e.g. HIV infection, or hepatitis B or C infection
5. Presence of malignancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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80 participants in 1 patient group

mesenchymal stem cells

Experimental group

Description:

To study the safety and efficacy of autologous transplantation of bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.

Treatment:

Biological: Autologous transplantation