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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01157403

Enrollment

Registered

2010-07-07

Start date

2010-07-31

Completion date

2014-08-31

Last updated

2013-06-18

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

Conditions

Evidence of Liver Transplantation

Keywords

mesenchymal stem cells

Brief summary

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.

Detailed description

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

Interventions

BIOLOGICALAutologous transplantation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

10 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
C peptide release test	6 Months after intervention	The concentration of c-peptide at 90 minutes after the start of the C-peptide release test at 24 Months following the infusion or not with bone marrow mesenchymal stem cells

Countries

China

Contacts

Primary ContactChen bing, doctor

903262619@qq.com

Backup Contactlu debin, doctor

ldb2005056@yahoo.com.cn

Outcome results

None listed

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