ClinicalTrials.Veeva

Menu

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

L

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

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

Trial contacts and locations

1

Loading...

Central trial contact

Chen bing, doctor; lu debin, doctor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems